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  • 1.
    Bergström, Hannah
    et al.
    Department of Surgery, Faculty of Medicine and Health, Örebro University, Örebro, Sweden.
    Larsson, Lars-Göran
    Department of Surgery, Faculty of Medicine and Health, Örebro University, Örebro, Sweden.
    Stenberg, Erik
    Örebro University, School of Medical Sciences. Örebro University Hospital. Department of Surgery.
    Audio-video recording during laparoscopic surgery reduces irrelevant conversation between surgeons: a cohort study2018In: BMC Surgery, ISSN 1471-2482, E-ISSN 1471-2482, Vol. 18, no 1, article id 92Article in journal (Refereed)
    Abstract [en]

    BACKGROUND: The prevalence of perioperative surgical complications is a worldwide issue: In many cases, these events are preventable. Audio-video recording during laparoscopic surgery provides useful information for the purposes of education and event analyses, and may have an impact on the focus of the surgeons operating. The aim of the present study was to investigate how audio-video recording in the operating room during laparoscopic surgery affects the focus of the surgeon and his/her assistant.

    METHODS: A group of laparoscopic procedures where video recording only was performed was compared to a group where both audio and video recordings were made. All laparoscopic procedures were performed at Lindesberg Hospital, Sweden, during the period August to September 2017. The primary outcome was conversation not relevant to the ongoing procedure. Secondary outcomes were intra- and postoperative adverse events or complications, operation time and number of times the assistant was corrected by the surgeon.

    RESULTS: The study included 41 procedures, 20 in the video only group and 21 in the audio-video group. The material comprised laparoscopic cholecystectomies, totally extraperitoneal inguinal hernia repairs and bariatric surgical procedures. Irrelevant conversation time fell from 4.2% of surgical time to 1.4% when both audio and video recordings were made (p = 0.002). No differences in perioperative adverse event or complication rates were seen.

    CONCLUSION: Audio-video recording during laparoscopic abdominal surgery reduces irrelevant conversation time and may improve intraoperative safety and surgical outcome.

    TRIAL REGISTRATION: Available at FOU Sweden (ID: 232771) and retrospectively at Clinical trials.gov (ID: NCT03425175 ; date of registration 7/2 2018).

  • 2.
    Cao, Yang
    et al.
    Örebro University, School of Medical Sciences. Örebro University Hospital.
    Fang, Xin
    Unit of Biostatistics, Institute of Environmental Medicine, Karolinska Institutet, Stockholm, Sweden.
    Ottosson, Johan
    Örebro University, School of Medical Sciences. Örebro University Hospital. Department of Surgery.
    Näslund, Erik
    Division of Surgery, Department of Clinical Sciences, Danderyd Hospital, Karolinska Institutet, Stockholm, Sweden.
    Stenberg, Erik
    Örebro University, School of Medical Sciences. Örebro University Hospital. Department of Surgery.
    A Comparative Study of Machine Learning Algorithms in Predicting Severe Complications after Bariatric Surgery2019In: Journal of Clinical Medicine, ISSN 2077-0383, Vol. 8, no 5, article id 668Article in journal (Refereed)
    Abstract [en]

    Background: Severe obesity is a global public health threat of growing proportions. Accurate models to predict severe postoperative complications could be of value in the preoperative assessment of potential candidates for bariatric surgery. So far, traditional statistical methods have failed to produce high accuracy. We aimed to find a useful machine learning (ML) algorithm to predict the risk for severe complication after bariatric surgery.

    Methods: We trained and compared 29 supervised ML algorithms using information from 37,811 patients that operated with a bariatric surgical procedure between 2010 and 2014 in Sweden. The algorithms were then tested on 6250 patients operated in 2015. We performed the synthetic minority oversampling technique tackling the issue that only 3% of patients experienced severe complications.

    Results: Most of the ML algorithms showed high accuracy (>90%) and specificity (>90%) in both the training and test data. However, none of the algorithms achieved an acceptable sensitivity in the test data. We also tried to tune the hyperparameters of the algorithms to maximize sensitivity, but did not yet identify one with a high enough sensitivity that can be used in clinical praxis in bariatric surgery. However, a minor, but perceptible, improvement in deep neural network (NN) ML was found.

    Conclusion: In predicting the severe postoperative complication among the bariatric surgery patients, ensemble algorithms outperform base algorithms. When compared to other ML algorithms, deep NN has the potential to improve the accuracy and it deserves further investigation. The oversampling technique should be considered in the context of imbalanced data where the number of the interested outcome is relatively small.

  • 3.
    Jaensson, Maria
    et al.
    Örebro University, School of Health Sciences.
    Dahlberg, Karuna
    Örebro University, School of Health Sciences.
    Nilsson, Ulrica
    Division of Nursing, Department of Neurobiology, Care Sciences, and Society, Karolinska Institute, Stockholm, Sweden; Perioperative Medicine & Intensive Care, Karolinska University Hospital, Stockholm, Sweden.
    Stenberg, Erik
    Örebro University, School of Medical Sciences. Örebro University Hospital. Department of Surgery.
    The impact of self-efficacy and health literacy on outcome after bariatric surgery in Sweden: a protocol for a prospective, longitudinal mixed methods study2019In: BMJ Open, ISSN 2044-6055, E-ISSN 2044-6055, Vol. 9, no 5, article id e027272Article in journal (Refereed)
    Abstract [en]

    INTRODUCTION: A person-centred approach, to know about a person's individual weaknesses and strengths, is warranted in today's healthcare in Sweden. When a person suffers from obesity, there are not only risks for comorbidities but also increased risk for decreased health-related quality of life (HRQoL). After bariatric surgery, there are also risks for complications; however, healthcare service expects the person to have sufficient ability to handle recovery after surgery. The need is to investigate how a person's self-efficacy and health literacy(HL) skills are important to determine their effect on recovery as well as HRQoL after bariatric surgery. It can, involve the person in the care, improve shared decision-making, and perhaps decrease complications and readmissions.

    METHOD AND ANALYSIS: This is a prospective, longitudinal mixed-methods study with the intent of including 700 patients from three bariatric centres in Sweden (phase 1); 20 patients will be included in a qualitative study (phase 2). Inclusion criteria will be age >17 years, scheduled primary bariatric surgery and ability to read and understand the Swedish language in speech and in writing. Inclusion criteria for the qualitative study will be patients who reported a low self-efficacy, with a selection to ensure maximum variation regarding age and gender. Before bariatric surgery patients will answer a questionnaire including 20 items. Valid and reliable instruments will be used to investigate general self-efficacy (10 items) and functional and communicative and critical HL (10 items). This data collection will then be merged with data from the Scandinavian Obesity Surgery Registry. Analysis will be performed 30 days, 1 year and 2 years after bariatric surgery. One year after bariatric surgery the qualitative study will be performed. The main outcomes are the impact of a person's self-efficacy and HL on recovery after bariatric surgery.

    ETHICS AND DISSEMINATION: The study has received approval from the ethical review board in Uppsala, Sweden (number 2018/256). The study results will be disseminated through peer-reviewed publications and conference presentations to the scientific community and social media.

  • 4.
    Kedestig, Jonna
    et al.
    Department of Surgery, Faculty of Medicine and Health, Örebro University, Örebro, Sweden.
    Stenberg, Erik
    Örebro University, School of Medical Sciences. Örebro University Hospital. Department of Surgery.
    Loss to follow-up after laparoscopic gastric bypass surgery - a post hoc analysis of a randomized clinical trial2019In: Surgery for Obesity and Related Diseases, ISSN 1550-7289, E-ISSN 1878-7533, Vol. 15, no 6, p. 880-886Article in journal (Refereed)
    Abstract [en]

    Background: Follow-up after bariatric surgery is important if we are to identify long-term complications at an early stage and thereby improve long-term outcome. Despite great efforts, many patients are lost to follow-up. Definition of characteristics of patients failing to attend follow-up could help in defining a specific group for whom extra resources may be applied to improve the situation.

    Objectives: To identify characteristics of patients failing to attend follow-up 2 years after laparoscopic gastric bypass surgery.

    Setting: Multicenter study, Sweden.

    Methods: Post hoc analysis of a randomized clinical trial in which preoperative patient characteristics and postoperative outcome measures were compared between patients who attended or did not attend a 2-year follow-up visit after laparoscopic gastric bypass surgery.

    Results: Of the 2495 patients included, 260 did not attend a 2-year follow-up visit. Factors associated with higher risk for failure to attend were younger age (adjusted odds ratio [OR] .96, 95% confidence interval [CI].94.98/yr, P < .001); male sex (adjusted OR 2.34, 95% CI 1.51-3.63, P < .001); depression (adjusted OR 1.61, 95% CI 1.05-2.47, P = .029); history of smoking (adjusted OR 1.78, 95% CI 1.26-2.51, P = .001); being single (adjusted OR 1.47, 95% CI 1.03-2.11, P = .036); and being first generation immigrant (adjusted OR 1.74, 95% CI 1.05-2.88; P = .032). Elementary occupation (adjusted OR .42, 95% CI .18.99, P = .047) was associated with lower risk.

    Conclusion: These findings indicate that there are preoperative characteristics that may help in identifying patients likely to fail to attend follow-up visits after laparoscopic gastric bypass surgery. Special effort should be made to inform these patients of the importance of follow-up and to encourage them to attend.

  • 5.
    Lundvall, Emma
    et al.
    Department of Surgery, Faculty of Medicine and Health, Örebro University, Örebro, Sweden.
    Ottosson, Johan
    Örebro University, School of Medical Sciences. Örebro University Hospital. Department of Surgery.
    Stenberg, Erik
    Örebro University, School of Medical Sciences. Örebro University Hospital. Department of Surgery.
    The influence of staple height on postoperative complication rates after laparoscopic gastric bypass surgery using linear staplers2019In: Surgery for Obesity and Related Diseases, ISSN 1550-7289, E-ISSN 1878-7533, Vol. 15, no 3, p. 404-408Article in journal (Refereed)
    Abstract [en]

    Background: The use of circular staplers with a low staple height is associated with a lower risk for complication when used to construct the gastroenterostomy in laparoscopic gastric bypass surgery. The influence of staple height on outcome when using linear staplers has not been studied.

    Objectives: To investigate the influence of staple height when constructing the gastric pouch and gastroenterostomy using a linear stapler in laparoscopic gastric bypass surgery.

    Setting: Nationwide, Sweden.

    Methods: A retrospective, register-based cohort study, including all primary laparoscopic gastric bypass surgical procedures in Sweden registered in the Scandinavian Obesity Surgery Registry from January 2010 until January 2017, where linear staplers were used to construct the gastric pouch and the gastroenterostomy. Low stapler heights (closed height <= 1.0 mm) were compared with higher stapler heights (closed height >= 1.5 mm). The main outcome was postoperative complication within 30 days of surgery.

    Results: Within the study period, 27,975 patients were identified from the Scandinavian Obesity Surgery Registry. A closed staple height >= 1.5 mm was associated with higher risk for postoperative complication within 30 days of surgery compared with lower staple height. The risk was greater when used to construct the gastric pouch (adjusted odd ratio 1.30, 95% confidence interval 1.17-1.44, P < .001) as well as when constructing the gastroenterostomy (adjusted odd ratio 1.32, 95% confidence interval 1.20-1.45, P < .001).

    Conclusion: The use of low staple height for construction of the gastric pouch and gastroenterostomy in laparoscopic gastric bypass surgery was associated with lower complication rates. (C) 2019 American Society for Bariatric Surgery. Published by Elsevier Inc. All rights reserved.

  • 6.
    Stenberg, Erik
    Örebro University, School of Medical Sciences. Örebro University Hospital.
    Preventing complications in bariatric surgery2016Doctoral thesis, comprehensive summary (Other academic)
    Abstract [en]

    Obesity is a major public health problem. Bariatric surgery is currently the only available treatment that offers sufficient weight-loss and metabolic benefits over time. Although bariatric surgery is considered safe now, serious complications still occur. The aim of this thesis was to identify factors associated with an increased risk for postoperative complication after laparoscopic gastric bypass surgery.

    Study I included patients operated with laparoscopic gastric bypass surgery in Sweden from May 2007 until September 2012. The risk for serious complication was low (3.4%). Suffering an intraoperative adverse event or conversion of the operation to open surgery were the strongest risk factors for postoperative complication. The annual operative volume and experience of the procedure at the institution were also important risk factors. Patient-specific risk factors appeared to be less important although age was associated with an increased risk. In Study II, a raised glycated haemoglobin A1c (HbA1c) was evaluated as a risk factor for serious postoperative complications in non-diabetics. A higher incidence of serious postoperative complications was seen with elevated HbA1c values, even at levels classified as ‘‘pre-diabetic’’.

    Study III was a multicentre, randomised clinical trial (RCT). 2507 patients planned for laparoscopic gastric bypass surgery were randomised to either mesenteric defects closure or non-closure. Closure of the mesenteric defects reduced the rate of reoperation for small bowel obstruction from 10.2% to 5.5% at 3 years after surgery. A small increase in the rate of serious postoperative complication within the first 30 days was seen with mesenteric defects closure. This relatively small increase in risk was however outweighed by the marked reduction of later reoperations for small bowel obstruction.

    Study IV was a comparison between study III and an observational study on the same population under the same period of time. Although the observational study reached the same conlusion as the RCT, the efficacy of mesenteric defects closure was less pronounced. Observational studies may thus be an alternative to RCTs under situations when RCTs are not feasible. The efficacy may however be underestimated.

    List of papers
    1. Early complications after laparoscopic gastric bypass surgery: results from the Scandinavian Obesity Surgery Registry
    Open this publication in new window or tab >>Early complications after laparoscopic gastric bypass surgery: results from the Scandinavian Obesity Surgery Registry
    Show others...
    2014 (English)In: Annals of Surgery, ISSN 0003-4932, E-ISSN 1528-1140, Vol. 260, no 6, p. 1040-1047Article in journal (Refereed) Published
    Abstract [en]

    OBJECTIVE: To identify risk factors for serious and specific early complications of laparoscopic gastric bypass surgery using a large national cohort of patients.

    BACKGROUND: Bariatric procedures are among the most common surgical procedures today. There is, however, still a need to identify preoperative and intraoperative risk factors for serious complications.

    METHODS: From the Scandinavian Obesity Surgery Registry database, we identified 26,173 patients undergoing primary laparoscopic gastric bypass operation for morbid obesity between May 1, 2007, and September 30, 2012. Follow-up on day 30 was 95.7%. Preoperative data and data from the operation were analyzed against serious postoperative complications and specific complications.

    RESULTS: The overall risk of serious postoperative complications was 3.4%. Age (adjusted P = 0.028), other additional operation [odds ratio (OR) = 1.50; confidence interval (CI): 1.04-2.18], intraoperative adverse event (OR = 2.63; 1.89-3.66), and conversion to open surgery (OR = 4.12; CI: 2.47-6.89) were all risk factors for serious postoperative complications. Annual hospital volume affected the rate of serious postoperative complications. If the hospital was in a learning curve at the time of the operation, the risk for serious postoperative complications was higher (OR = 1.45; CI: 1.22-1.71). The 90-day mortality rate was 0.04%.

    CONCLUSIONS: Intraoperative adverse events and conversion to open surgery are the strongest risk factors for serious complications after laparoscopic gastric bypass surgery. Annual operative volume and total institutional experience are important for the outcome. Patient related factors, in particular age, also increased the risk but to a lesser extent.

    Place, publisher, year, edition, pages
    Lippincott Williams & Wilkins, 2014
    Keywords
    bariatric surgery; laparoscopic gastric bypass; postoperative complications; risk factors
    National Category
    Surgery
    Research subject
    Surgery
    Identifiers
    urn:nbn:se:oru:diva-40584 (URN)10.1097/SLA.0000000000000431 (DOI)000345217200018 ()24374541 (PubMedID)2-s2.0-84922330659 (Scopus ID)
    Conference
    6th Congress of the International Federation for the Surgery of Obesity and Metabolic Disorders, European Chapter, Brussels, Belgium, April 30 - May 3, 2014
    Projects
    Preventing complications in bariatric surgery
    Available from: 2015-01-15 Created: 2015-01-08 Last updated: 2018-06-15Bibliographically approved
    2. Is glycosylated hemoglobin A1c associated with increased risk for severe early postoperative complications in nondiabetics after laparoscopic gastric bypass?
    Open this publication in new window or tab >>Is glycosylated hemoglobin A1c associated with increased risk for severe early postoperative complications in nondiabetics after laparoscopic gastric bypass?
    2014 (English)In: Surgery for Obesity and Related Diseases, ISSN 1550-7289, E-ISSN 1878-7533, Vol. 10, no 5, p. 801-805Article in journal (Refereed) Published
    Abstract [en]

    BACKGROUND: Glycosylated hemoglobin A1 c (HbA1 c) has been described as a risk factor for adverse outcome after cardiovascular and colorectal surgery, but not for obese patients undergoing bariatric surgery. The objective of this study was to see if there is an association between HbA1 c and adverse outcome in laparoscopic gastric bypass surgery.

    METHODS: From the Scandinavian Obesity Surgery Registry we identified 12,850 patients, without treatment for diabetes and operated with laparoscopic gastric bypass between January 1, 2010 and September 30, 2012, and where a baseline HbA1 c value was registered. Preoperative data were compared with data from a 30-day follow-up. Severe complications were defined according to the Clavien-Dindo-Scale as Grade 3 b or higher.

    RESULTS: HbA1 c levels below 5.7 % were associated with a lower incidence of severe complications (2.7 %) than higher levels (HbA1 c 5.7-6.49% incidence 3.5%, P = .015; HbA1 c>6.5%, incidence 4.5%, P = .012). After multivariate analysis with patient-specific confounders the difference remained significant (HbA1 c 5.7-6.49% adjusted P = .046; HbA1 c>6.5% adjusted P = .023) CONCLUSION: Elevated HbA1 c levels in patients without pharmacologic treatment for diabetes undergoing laparoscopic gastric bypass surgery is associated with an increased risk for severe complications during the first 30 postoperative days. This is the case, even at levels not regarded as diagnostic for diabetes.

    Place, publisher, year, edition, pages
    Elsevier, 2014
    Keywords
    hemoglobin A1c, Nondiabetic, Postoperative complications, laparoscopic gastric bypass, risk factor
    National Category
    Surgery
    Research subject
    Surgery
    Identifiers
    urn:nbn:se:oru:diva-40585 (URN)10.1016/j.soard.2014.05.005 (DOI)000344719200009 ()25304835 (PubMedID)2-s2.0-84928828943 (Scopus ID)
    Conference
    Obesity week, Atlanta, Georgia, USA, November 11-16, 2013
    Projects
    Preventing complications in bariatric surgery
    Note

    Sponsor:

    Orebro County Council

    Available from: 2015-01-15 Created: 2015-01-08 Last updated: 2018-04-16Bibliographically approved
    3. Closure of mesenteric defects in laparoscopic gastric bypass: a multicentre, randomised, parallel, open-label trial
    Open this publication in new window or tab >>Closure of mesenteric defects in laparoscopic gastric bypass: a multicentre, randomised, parallel, open-label trial
    Show others...
    2016 (English)In: The Lancet, ISSN 0140-6736, E-ISSN 1474-547X, Vol. 387, no 10026, p. 1397-1404Article in journal (Refereed) Published
    Abstract [en]

    Background: Small bowel obstruction due to internal hernia is a common and potentially serious complication after laparoscopic gastric bypass surgery. Whether closure of surgically created mesenteric defects might reduce the incidence is unknown, so we did a large randomised trial to investigate.

    Method: This study was a multicentre, randomised trial with a two-arm, parallel design done at 12 centres for bariatric surgery in Sweden. Patients planned for laparoscopic gastric bypass surgery at any of the participating centres were off ered inclusion. During the operation, a concealed envelope was opened and the patient was randomly assigned to either closure of mesenteric defects beneath the jejunojejunostomy and at Petersen's space or non-closure. After surgery, assignment was open label. The main outcomes were reoperation for small bowel obstruction and severe postoperative complications. Outcome data and safety were analysed in the intention-to-treat population. This trial is registered with ClinicalTrials. gov, number NCT01137201.

    Findings: Between May 1, 2010, and Nov 14, 2011, 2507 patients were recruited to the study and randomly assigned to closure of the mesenteric defects (n= 1259) or non-closure (n= 1248). 2503 (99.8%) patients had follow-up for severe postoperative complications at day 30 and 2482 (99.0%) patients had follow-up for reoperation due to small bowel obstruction at 25 months. At 3 years after surgery, the cumulative incidence of reoperation because of small bowel obstruction was signifi cantly reduced in the closure group (cumulative probability 0.055 for closure vs 0.102 for non-closure, hazard ratio 0.56, 95% CI 0.41-0.76, p= 0.0002). Closure of mesenteric defects increased the risk for severe postoperative complications (54 [4.3%] for closure vs 35 [2.8%] for non-closure, odds ratio 1.55, 95% CI 1.01-2.39, p= 0.044), mainly because of kinking of the jejunojejunostomy.

    Interpretation: The results of our study support the routine closure of the mesenteric defects in laparoscopic gastric bypass surgery. However, closure of the mesenteric defects might be associated with increased risk of early small bowel obstruction caused by kinking of the jejunojejunostomy.

    Place, publisher, year, edition, pages
    Elsevier, 2016
    National Category
    General Practice
    Research subject
    Family Medicine
    Identifiers
    urn:nbn:se:oru:diva-50057 (URN)10.1016/S0140-6736(15)01126-5 (DOI)000373217500032 ()26895675 (PubMedID)2-s2.0-84958064283 (Scopus ID)
    Note

    Funding Agencies:

    Örebro County Council

    Stockholm City Council

    Erling-Persson Family Foundation

    Available from: 2016-05-02 Created: 2016-05-02 Last updated: 2019-03-07Bibliographically approved
    4. Laparoscopic gastric bypass: comparison of outcomes from a randomised controlled trial and a concurrent observational study
    Open this publication in new window or tab >>Laparoscopic gastric bypass: comparison of outcomes from a randomised controlled trial and a concurrent observational study
    (English)Manuscript (preprint) (Other academic)
    National Category
    Surgery
    Research subject
    Surgery
    Identifiers
    urn:nbn:se:oru:diva-52069 (URN)
    Available from: 2016-09-09 Created: 2016-09-08 Last updated: 2017-10-17Bibliographically approved
  • 7.
    Stenberg, Erik
    et al.
    Örebro University, School of Medical Sciences. Örebro University Hospital. Department of Surgery, Örebro University Hospital, Örebro, Sweden.
    Cao, Yang
    Örebro University, School of Medical Sciences. Örebro University Hospital. Unit of Biostatistics, Institute of Environmental Medicine, Karolinska Institutet, Stockholm, Sweden.
    Szabo, Eva
    Örebro University, School of Medical Sciences. Örebro University Hospital. Department of Surgery, Örebro University Hospital, Örebro, Sweden.
    Näslund, Erik
    Division of Surgery, Department of Clinical Sciences, Danderyd Hospital, Karolinska Institutet, Stockholm, Sweden.
    Näslund, Ingmar
    Department of Surgery, Örebro University Hospital, Örebro, Sweden.
    Ottosson, Johan
    Örebro University, School of Medical Sciences. Örebro University Hospital. Department of Surgery, Örebro University Hospital, Örebro, Sweden.
    Risk Prediction Model for Severe Postoperative Complication in Bariatric Surgery2018In: Obesity Surgery, ISSN 0960-8923, E-ISSN 1708-0428, Vol. 28, no 7, p. 1869-1875Article in journal (Refereed)
    Abstract [en]

    BACKGROUND: Factors associated with risk for adverse outcome are important considerations in the preoperative assessment of patients for bariatric surgery. As yet, prediction models based on preoperative risk factors have not been able to predict adverse outcome sufficiently.

    OBJECTIVE: This study aimed to identify preoperative risk factors and to construct a risk prediction model based on these.

    METHODS: Patients who underwent a bariatric surgical procedure in Sweden between 2010 and 2014 were identified from the Scandinavian Obesity Surgery Registry (SOReg). Associations between preoperative potential risk factors and severe postoperative complications were analysed using a logistic regression model. A multivariate model for risk prediction was created and validated in the SOReg for patients who underwent bariatric surgery in Sweden, 2015.

    RESULTS: Revision surgery (standardized OR 1.19, 95% confidence interval (CI) 1.14-0.24, p < 0.001), age (standardized OR 1.10, 95%CI 1.03-1.17, p = 0.007), low body mass index (standardized OR 0.89, 95%CI 0.82-0.98, p = 0.012), operation year (standardized OR 0.91, 95%CI 0.85-0.97, p = 0.003), waist circumference (standardized OR 1.09, 95%CI 1.00-1.19, p = 0.059), and dyspepsia/GERD (standardized OR 1.08, 95%CI 1.02-1.15, p = 0.007) were all associated with risk for severe postoperative complication and were included in the risk prediction model. Despite high specificity, the sensitivity of the model was low.

    CONCLUSION: Revision surgery, high age, low BMI, large waist circumference, and dyspepsia/GERD were associated with an increased risk for severe postoperative complication. The prediction model based on these factors, however, had a sensitivity that was too low to predict risk in the individual patient case.

  • 8.
    Stenberg, Erik
    et al.
    Örebro University, School of Medical Sciences. Örebro University Hospital. Department of Surgery.
    Mohseni, Shahin
    Örebro University, School of Medical Sciences. Örebro University Hospital. Department of Surgery.
    Cao, Yang
    Örebro University, School of Medical Sciences. Örebro University Hospital.
    Näslund, Erik
    Division of Surgery, Department of Clinical Sciences, Danderyd Hospital, Karolinska Institute, Stockholm, Sweden.
    Limited Effect of Beta-blockade on Postoperative Outcome After Laparoscopic Gastric Bypass Surgery2019In: Obesity Surgery, ISSN 0960-8923, E-ISSN 1708-0428Article in journal (Refereed)
    Abstract [en]

    BACKGROUND: The benefit of beta-blockade on postoperative outcome remains controversial, though recent studies have suggested a role during major non-cardiac surgery. The benefit of beta-blockade during minimally invasive gastric bypass surgery remains unclear. The aim of the present study was to evaluate the possible association between preoperative beta-blocker therapy and postoperative outcome after laparoscopic gastric bypass surgery.

    METHODS: Patients operated with primary laparoscopic gastric bypass surgery in Sweden between 2007 and 2017 were identified through the Scandinavian Obesity Surgery Registry. The dataset was linked to the Swedish National Patient Registry, the Swedish Prescribed Drug Registry, and Statistics Sweden. The main outcome was serious postoperative complication within 30 days of surgery; with postoperative complication, 90-day and 1-year mortality, and weight loss at 2 years after surgery as secondary endpoints. The Poisson regression model was used to evaluate primary and secondary categorical outcomes. A general mixed model was performed to evaluate 2-year weight loss.

    RESULTS: In all, 50281 patients were included in the study. No difference was seen between patients on beta-blockade and the control group regarding postoperative complications (adjusted incidence rate ratio 1.04 (95%CI 0.93-1.15), p = 0.506), serious postoperative complication (adjusted IRR 1.06 95%CI 0.89-1.27), p = 0.515), 90-day mortality (adjusted IRR 0.71 (95%CI 0.24-2.10), p = 0.537), and 1-year mortality (adjusted IRR 1.26 (95%CI 0.67-2.36), p = 0.467). Weight loss 2 years after surgery was slightly greater in patients on beta-blockade (adjusted coefficient 0.53 (95%CI 0.19-0.87), p = 0.002).

    CONCLUSIONS: Beta-blockade has limited impact on postoperative outcome after laparoscopic gastric bypass surgery.

  • 9.
    Stenberg, Erik
    et al.
    Örebro University, School of Medical Sciences. Örebro University Hospital. Department of Surgery.
    Näslund, Ingmar
    Department of Surgery, Faculty of Medicine and Health, Örebro University, Örebro , Sweden.
    Szabo, Eva
    Örebro University, School of Medical Sciences. Örebro University Hospital. Department of Surgery.
    Ottosson, Johan
    Örebro University, School of Medical Sciences. Örebro University Hospital. Department of Surgery.
    Impact of mesenteric defect closure technique on complications after gastric bypass2018In: Langenbeck's archives of surgery (Print), ISSN 1435-2443, E-ISSN 1435-2451, Vol. 403, no 4, p. 481-486Article in journal (Refereed)
    Abstract [en]

    BACKGROUND: Closure of mesenteric defects during laparoscopic gastric bypass surgery markedly reduces the risk for small bowel obstruction due to internal hernia. However, this procedure is associated with an increased risk for early small bowel obstruction and pulmonary complication. The purpose of the present study was to evaluate whether the learning curve and subsequent adaptions made to the technique have had an effect on the risk for complications.

    METHODS: The results of patients operated with a primary laparoscopic gastric bypass procedure, including closure of the mesenteric defects with sutures, during a period soon after introduction (January 1, 2010-December 31, 2011) were compared to those of patients operated recently (January 1, 2014-June 30, 2017). Data were retrieved from the Scandinavian Obesity Surgery Registry (SOReg). The main outcome was reoperation for small bowel obstruction within 30 days after surgery.

    RESULTS: A total of 5444 patients were included in the first group (period 1), and 1908 in the second group (period 2). Thirty-day follow-up rates were 97.1 and 97.5% respectively. The risk for early (within 30 days) small bowel obstruction was lower in period 2 than in period 1 (13/1860, 0.7% vs. 67/5285, 1.3%, OR 0.55 (0.30-0.99), p = 0.045). The risk for pulmonary complication was also reduced (5/1860, 0.3%, vs. 41/5285, 0.8%, OR 0.34 (0.14-0.87), p = 0.019).

    CONCLUSION: Closure of mesenteric defects during laparoscopic gastric bypass surgery can be performed safely and should be viewed as a routine part of that operation.

  • 10.
    Stenberg, Erik
    et al.
    Örebro University, School of Medical Sciences. Örebro University Hospital. Department of Surgery.
    Ottosson, Johan
    Örebro University, School of Medical Sciences. Örebro University Hospital. Department of Surgery.
    Szabo, Eva
    Örebro University, School of Medical Sciences. Örebro University Hospital. Department of Surgery.
    Näslund, Ingmar
    Department of Surgery, Faculty of Medicine and Health, Örebro University, Örebro, Sweden.
    Comparing Techniques for Mesenteric Defects Closure in Laparoscopic Gastric Bypass Surgery: a Register-Based Cohort Study2019In: Obesity Surgery, ISSN 0960-8923, E-ISSN 1708-0428, Vol. 29, no 4, p. 1229-1235Article in journal (Refereed)
    Abstract [en]

    BACKGROUND: Routine closure of mesenteric defects is generally considered standard part of laparoscopic gastric bypass surgery today. Controversy still exists regarding the optimal method for mesenteric defects closure. The objective was to compare different methods for mesenteric defects handling in laparoscopic gastric bypass surgery.

    METHODS: Primary laparoscopic gastric bypass procedures from 2010 until 2015 reported to the Scandinavian Obesity Surgery Registry (SOReg), where the mesenteric defects closure method was identifiable, were included. Main outcome measures were serious postoperative complication within 30 days after surgery, and reoperation for small bowel obstruction within 5 years after surgery. Quality-of-life before and after surgery, duration of surgery, and risk factors for complication were also analyzed. Information on operation for small bowel obstruction was based on data from the SOReg, the Swedish National Patient Register and reviews of hospital charts.

    RESULTS: In all, 34,707 patients were included. Serious postoperative complication occurred in 174 (2.9%) patients with sutures, in 592 (3.1%, adjusted p = 0.079) with clips, and 278 (3.1%; adjusted p = 0.658) in the non-closure group. Reoperation for small bowel obstruction within 5 years after surgery was lower with sutures (cumulative incidence 6.9%) and clips (cumulative incidence 7.3%; adjusted HR 1.16, 95% CI 1.02-1.32, p = 0.026), compared to non-closure (cumulative incidence 11.2%; adjusted HR 1.63, 95% CI 1.44-1.84, p < 0.0001).

    CONCLUSION: Closure of the mesenteric defects using either non-absorbable metal clips or non-absorbable running sutures is a safe and effective measure to reduce the risk for small bowel obstruction after laparoscopic gastric bypass surgery. Sutures appear slightly more effective and should remain gold standard for mesenteric defects closure.

  • 11.
    Stenberg, Erik
    et al.
    Örebro University, School of Medical Sciences. Örebro University Hospital. Department of Surgery.
    Persson, Carina
    Department of Community Medicine and Public Health, Faculty of Medicine and Health, Örebro University, Örebro, Sweden; Department for Sustainable Development, Region Örebro County, Örebro, Sweden.
    Näslund, Erik
    Division of Surgery, Department of Clinical Sciences, Danderyd Hospital, Karolinska Institutet, Stockholm, Sweden.
    Ottosson, Johan
    Örebro University, School of Medical Sciences. Örebro University Hospital. Department of Surgery.
    Sundbom, Magnus
    Department of Surgical Sciences, Uppsala University, Uppsala, Sweden.
    Szabo, Eva
    Örebro University, School of Medical Sciences. Örebro University Hospital. Department of Surgery.
    Näslund, Ingmar
    Department of Surgery, Faculty of Medicine and Health, Örebro University, Örebro, Sweden.
    The impact of socioeconomic factors on the early postoperative complication rate after laparoscopic gastric bypass surgery: A register-based cohort study2019In: Surgery for Obesity and Related Diseases, ISSN 1550-7289, E-ISSN 1878-7533, Vol. 15, no 4, p. 575-581Article in journal (Refereed)
    Abstract [en]

    Background: Socioeconomic factors may influence the outcome of certain surgical procedures, but it is not known whether such factors influence the risk for postoperative complication after bariatric surgery.

    Objectives: Determining whether different socioeconomic factors influence the risk for postoperative complication after laparoscopic gastric bypass surgery.

    Setting: Nationwide in Sweden.

    Methods: Retrospective register-based cohort study that includes all primary laparoscopic gastric bypass procedures in Sweden between 2010 and 2016, using data from the Scandinavian Obesity Surgery Registry, Statistics Sweden, and the Swedish Population Register. Main outcome measures were occurrence and severity of early postoperative complications.

    Results: Included in this study were 41,537 patients with 30-day follow-up percentage of 96.7%. Study groups with increased risk for postoperative complication (age, sex, body mass index, and co-morbidity adjusted odds ratio with 95% confidence intervals) were as follows: being divorced, a widow, or a widower (1.14 [1.03-1.23]); receiving disability pension (1.37 [1.23-1.53]) or social assistance (1.22 [1.07-1.401); and being first- (1.22 [1.04-1.44]) or second-generation (1.20 [1.09-1.32]) immigrant. In contrast, being single (.90 [.83.991), having higher disposable income (50th-80th percentile:.84 [.76.93]; >80th percentile:.84 [72.98]), and living in a medium (.90 [.83.98]) or small (.84 [.76.92]) town were associated with lower risk. Increased risk for severe postoperative complication was seen for divorced, widowm, or widower (1.30 [1.12-1.521) and those receiving disability pension (1.37 [1.16-1.611) or social assistance (1.32 [1.08-1.62]), while higher disposable income (50th-80th percentile:.79 [.68.92]; >80th percentile .57 [.46.72]) was associated with lower risk.

    Conclusion: Socioeconomic factors influence the risk for early postoperative complication after laparoscopic gastric bypass surgery. The impact is not enough to exclude patients from surgery, but they must be taken into account in preoperative risk assessment.

  • 12.
    Stenberg, Erik
    et al.
    Örebro University, School of Medical Sciences. Department of Surgery.
    Ruoqing, Chen
    Örebro University, School of Medical Sciences. Örebro University Hospital. Department of Medical Epidemiology and Biostatistics, Karolinska Institutet, Stockholm, Sweden.
    Hildén, Karin
    Örebro University, School of Medical Sciences. Department of Obstetrics and Gynecology.
    Fall, Katja
    Örebro University, School of Medical Sciences. Department of Medical Epidemiology and Biostatistics, Karolinska Institutet, Stockholm, Sweden.
    Pregnancy As a Risk Factor for Small Bowel Obstruction After Laparoscopic Gastric Bypass Surgery2018In: Annals of Surgery, ISSN 0003-4932, E-ISSN 1528-1140Article in journal (Refereed)
    Abstract [en]

    OBJECTIVE: To evaluate whether pregnancy is associated with increased risk for small bowel obstruction after laparoscopic gastric bypass surgery.

    BACKGROUND: Small bowel obstruction is a common and feared long-term complication to laparoscopic gastric bypass surgery that may be more common during pregnancy. It is unclear if the risk truly increases during pregnancy.

    METHODS: Women, 18 to 55 years, operated with a primary laparoscopic gastric bypass procedure from 2010 until 2015 were identified through the Scandinavian Obesity Surgery Registry (n = 25,853). Through record-linkage to the Medical Birth Registry, the National Patient Registry, and review of hospital charts, information on pregnancy periods and outcome were obtained. The main outcome was operation due to small bowel obstruction after the laparoscopic gastric bypass procedure.

    RESULTS: Pregnancy was associated with increased risk for small bowel obstruction following laparoscopic gastric bypass surgery (incidence rates 46.5, 95% CI 38.0-56.9/1000 person-years, vs 20.9 95% CI 19.9-22.0; adjusted-HR 1.72, 95% CI 1.39-2.12, P < 0.001). While no excess risk was observed during the first trimester, the second (adjusted-HR 1.67, 95% CI 1.17-2.39, P = 0.005) and third (adjusted-HR 2.69, 95% CI 2.02-3.59, P < 0.001) conferred increased risk. The incidence rate of small bowel obstruction during pregnancy was 42.9 (95% CI 32.4-57.0/1000 person-years) among women for whom the mesenteric defects had been closed during the primary procedure, and 53.2 (95% CI 38.9-72.8/1000 person-years) for women in whom they had been left open.

    CONCLUSION: Pregnancy is associated with increased risk for small bowel obstruction after laparoscopic gastric bypass surgery during the second and third trimesters.

  • 13.
    Stenberg, Erik
    et al.
    Örebro University Hospital. Department of Surgery, Örebro University Hospital, Örebro, Sweden; Department of Surgery, Lindesberg Hospital, Lindesberg, Sweden .
    Szabo, Eva
    Örebro University Hospital. Department of Surgery.
    Näslund, Ingmar
    Örebro University Hospital. Department of Surgery.
    Is glycosylated hemoglobin A1c associated with increased risk for severe early postoperative complications in nondiabetics after laparoscopic gastric bypass?2014In: Surgery for Obesity and Related Diseases, ISSN 1550-7289, E-ISSN 1878-7533, Vol. 10, no 5, p. 801-805Article in journal (Refereed)
    Abstract [en]

    BACKGROUND: Glycosylated hemoglobin A1 c (HbA1 c) has been described as a risk factor for adverse outcome after cardiovascular and colorectal surgery, but not for obese patients undergoing bariatric surgery. The objective of this study was to see if there is an association between HbA1 c and adverse outcome in laparoscopic gastric bypass surgery.

    METHODS: From the Scandinavian Obesity Surgery Registry we identified 12,850 patients, without treatment for diabetes and operated with laparoscopic gastric bypass between January 1, 2010 and September 30, 2012, and where a baseline HbA1 c value was registered. Preoperative data were compared with data from a 30-day follow-up. Severe complications were defined according to the Clavien-Dindo-Scale as Grade 3 b or higher.

    RESULTS: HbA1 c levels below 5.7 % were associated with a lower incidence of severe complications (2.7 %) than higher levels (HbA1 c 5.7-6.49% incidence 3.5%, P = .015; HbA1 c>6.5%, incidence 4.5%, P = .012). After multivariate analysis with patient-specific confounders the difference remained significant (HbA1 c 5.7-6.49% adjusted P = .046; HbA1 c>6.5% adjusted P = .023) CONCLUSION: Elevated HbA1 c levels in patients without pharmacologic treatment for diabetes undergoing laparoscopic gastric bypass surgery is associated with an increased risk for severe complications during the first 30 postoperative days. This is the case, even at levels not regarded as diagnostic for diabetes.

  • 14.
    Stenberg, Erik
    et al.
    Örebro University, School of Medical Sciences. Örebro University Hospital. Department of Surgery, Örebro University Hospital, Örebro, Sweden.
    Szabo, Eva
    Örebro University, School of Medical Sciences. Örebro University Hospital. Department of Surgery, Örebro University Hospital, Örebro, Sweden.
    Näslund, Ingmar
    Department of Surgery, Örebro University Hospital, Örebro, Sweden.
    Ottosson, Johan
    Department of Surgery, Örebro University Hospital, Örebro, Sweden.
    Bleeding during laparoscopic gastric bypass surgery as a risk factor for less favorable outcome: A cohort study from the Scandinavian Obesity Surgery Registry2017In: Surgery for Obesity and Related Diseases, ISSN 1550-7289, E-ISSN 1878-7533, Vol. 13, no 10, p. 1735-1740Article in journal (Refereed)
    Abstract [en]

    BACKGROUND: Intraoperative adverse events are known to be associated with postoperative complications; however, little is known about whether or not blood loss during laparoscopic gastric bypass surgery affects the outcome.

    OBJECTIVE: To see if intraoperative bleeding was associated with a less favorable outcome, and to identify patient-specific risk factors for intraoperative bleeding.

    SETTING: Nationwide, Sweden.

    METHODS: Patients who underwent laparoscopic gastric bypass surgery between January 8, 2007, and September 15, 2015, were included in the study. The volume of intraoperative blood loss was compared with data from follow-up at day 30 and 1 and 2 years after surgery. Patient-specific factors were analyzed as potential risk factors for intraoperative bleeding.

    RESULTS: The study included 43,157 patients. Intraoperative bleeding was associated with an increased risk for postoperative complication (100-499 mL, odds ratio [OR] 2.97, 95% confidence interval [95%CI] 2.53-3.50;>500 mL OR 3.34, 95%CI 2.05-5.44), lower weight loss (<100 mL, 82.4±24.19% excess body mass index-loss [%EBMIL]; 100-499 mL, 76.9±24.24 %EBMIL, P<.0001;>500 mL 76.9±23.89 %EBMIL, P = .063) and lower reported quality-of-life 2 years after surgery (<100 mL, Obesity-related Problem scale (OP) 21.1±24.46; 100-499 mL, OP 25.0±26.62, P = .008;>500 mL, OP 25.2±24.46, P = .272). Diabetes (OR 1.30, 95%CI 1.08-1.58), age (OR 1.02, 95%CI 1.02-1.03), and body mass index (OR 1.03, 95%CI 1.02-1.05) were patient-specific risk factors for intraoperative bleeding≥100 mL, whereas intentional preoperative weight loss was associated with a lower risk (OR .50, 95%CI .43-.57).

    CONCLUSION: Intraoperative bleeding was associated with less favorable outcome after laparoscopic gastric bypass surgery. Age, body mass index, and diabetes were risk factors for intraoperative bleeding, while preoperative weight reduction seems to be protective.

  • 15.
    Stenberg, Erik
    et al.
    Örebro University, School of Medical Sciences. Department of Surgery.
    Szabo, Eva
    Department of Surgery, Faculty of Medicine and Health, Örebro University, Örebro, Sweden.
    Ottosson, Johan
    Department of Surgery, Faculty of Medicine and Health, Örebro University, Örebro, Sweden.
    Näslund, Ingmar
    Department of Surgery, Faculty of Medicine and Health, Örebro University, Örebro, Sweden.
    Laparoscopic gastric bypass: comparison of outcomes from a randomised controlled trial and a concurrent observational studyManuscript (preprint) (Other academic)
  • 16.
    Stenberg, Erik
    et al.
    Örebro University, School of Medical Sciences. Örebro University Hospital. Department of Surgery, Örebro University Hospital, Örebro, Sweden.
    Szabo, Eva
    Örebro University, School of Medical Sciences. Örebro University Hospital. Department of Surgery, Örebro University Hospital, Örebro, Sweden.
    Ottosson, Johan
    Department of Surgery, Faculty of Medicine and Health, Örebro University, Örebro, Sweden.
    Thorell, Anders
    Department of Surgery, Ersta Hospital, Stockholm, Sweden; Department of Clinical Sciences, Danderyd Hospital, Karolinska Institutet, Stockholm, Sweden.
    Näslund, Ingmar
    Department of Surgery, Faculty of Medicine and Health, Örebro University, Örebro, Sweden.
    Health-Related Quality-of-Life after Laparoscopic Gastric Bypass Surgery with or Without Closure of the Mesenteric Defects: a Post-hoc Analysis of Data from a Randomized Clinical Trial2018In: Obesity Surgery, ISSN 0960-8923, E-ISSN 1708-0428, Vol. 28, no 1, p. 31-36Article in journal (Refereed)
    Abstract [en]

    BACKGROUND: Mesenteric defect closure in laparoscopic gastric bypass surgery has been reported to reduce the risk for small bowel obstruction. Little is known, however, about the effect of mesenteric defect closure on patient-reported outcome. The aim of the present study was to see if mesenteric defect closure affects health-related quality-of-life (HRQoL) after laparoscopic gastric bypass.

    METHODS: Patients operated at 12 centers for bariatric surgery participated in this randomized two-arm parallel study. During the operation, patients were randomized to closure of the mesenteric defects or non-closure. This study was a post-hoc analysis comparing HRQoL of the two groups before surgery, at 1 and 2 years after the operation. HRQoL was estimated using the short form 36 (SF-36-RAND) and the obesity problems (OP) scale.

    RESULTS: Between May 1, 2010, and November 14, 2011, 2507 patients were included in the study and randomly assigned to mesenteric defect closure (n = 1259) or non-closure (n = 1248). In total, 1619 patients (64.6%) reported on their HRQoL at the 2-year follow-up. Mesenteric defect closure was associated with slightly higher rating of social functioning (87 ± 22.1 vs. 85 ± 24.2, p = 0.047) and role emotional (85 ± 31.5 vs. 82 ± 35.0, p = 0.027). No difference was seen on the OP scale (open defects 22 ± 24.8 vs. closed defects 20 ± 23.8, p = 0.125).

    CONCLUSION: When comparing mesenteric defect closure with non-closure, there is no clinically relevant difference in HRQoL after laparoscopic gastric bypass surgery.

  • 17.
    Stenberg, Erik
    et al.
    Örebro University Hospital. Department of Surgery, Lindesberg Hospital, Lindesberg, Sweden; Department of Surgery, Örebro University Hospital, Örebro, Sweden .
    Szabo, Eva
    Örebro University Hospital. Department of Surgery, Örebro University Hospital, Örebro, Sweden.
    Ågren, Göran
    Department of Surgery, Örebro University Hospital, Örebro, Sweden .
    Näslund, Erik
    Division of Surgery, Department of Clinical Sciences, Danderyd Hospital, Stockholm, Sweden .
    Boman, Lars
    Department of Surgery, Lycksele Hospital, Lycksele, Sweden .
    Bylund, Ami
    Department of Surgery, Ersta Hospital, Stockholm, Sweden .
    Hedenbro, Jan
    Skåne University Hospital, Lund University, Lund, Sweden; Department of Surgery, Aleris Obesity Skåne, Lund, Sweden .
    Laurenius, Anna
    Department of Surgery, Sahlgrenska University Hospital, University of Gothenburg, Gothenburg, Sweden .
    Lundegårdh, Göran
    Österlenskirurgin, Simrishamn Hospital, Simrishamn, Sweden .
    Lönroth, Hans
    Österlenskirurgin, Simrishamn Hospital, Simrishamn, Sweden .
    Möller, Peter
    Department of Surgery, Kalmar County Hospital, Kalmar, Sweden .
    Sundbom, Magnus
    Department of Surgical Sciences, Uppsala University, Uppsala, Sweden .
    Ottosson, Johan
    Örebro University Hospital. Department of Surgery, Lindesberg Hospital, Lindesberg, Sweden; Department of Surgery, Örebro University Hospital, Örebro, Sweden .
    Näslund, Ingmar
    Örebro University Hospital. Department of Surgery, Örebro University Hospital, Örebro, Sweden.
    Early complications after laparoscopic gastric bypass surgery: results from the Scandinavian Obesity Surgery Registry2014In: Annals of Surgery, ISSN 0003-4932, E-ISSN 1528-1140, Vol. 260, no 6, p. 1040-1047Article in journal (Refereed)
    Abstract [en]

    OBJECTIVE: To identify risk factors for serious and specific early complications of laparoscopic gastric bypass surgery using a large national cohort of patients.

    BACKGROUND: Bariatric procedures are among the most common surgical procedures today. There is, however, still a need to identify preoperative and intraoperative risk factors for serious complications.

    METHODS: From the Scandinavian Obesity Surgery Registry database, we identified 26,173 patients undergoing primary laparoscopic gastric bypass operation for morbid obesity between May 1, 2007, and September 30, 2012. Follow-up on day 30 was 95.7%. Preoperative data and data from the operation were analyzed against serious postoperative complications and specific complications.

    RESULTS: The overall risk of serious postoperative complications was 3.4%. Age (adjusted P = 0.028), other additional operation [odds ratio (OR) = 1.50; confidence interval (CI): 1.04-2.18], intraoperative adverse event (OR = 2.63; 1.89-3.66), and conversion to open surgery (OR = 4.12; CI: 2.47-6.89) were all risk factors for serious postoperative complications. Annual hospital volume affected the rate of serious postoperative complications. If the hospital was in a learning curve at the time of the operation, the risk for serious postoperative complications was higher (OR = 1.45; CI: 1.22-1.71). The 90-day mortality rate was 0.04%.

    CONCLUSIONS: Intraoperative adverse events and conversion to open surgery are the strongest risk factors for serious complications after laparoscopic gastric bypass surgery. Annual operative volume and total institutional experience are important for the outcome. Patient related factors, in particular age, also increased the risk but to a lesser extent.

  • 18.
    Stenberg, Erik
    et al.
    Department of Surgery, Faculty of Medicine and Health, Örebro University, Örebro, Sweden.
    Szabo, Eva
    Department of Surgery, Faculty of Medicine and Health, Örebro University, Örebro, Sweden.
    Ågren, Göran
    Department of Surgery, Faculty of Medicine and Health, Örebro University, Örebro, Sweden.
    Ottosson, Johan
    Department of Surgery, Faculty of Medicine and Health, Örebro University, Örebro, Sweden.
    Marsk, Richard
    Division of Surgery, Department of Clinical Sciences, Danderyd Hospital, Karolinska Institutet, Stockholm, Sweden.
    Lönroth, Hans
    Institute of Surgery, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden.
    Boman, Lars
    Department of Surgery, Lycksele Hospital, Lycksele, Sweden.
    Magnuson, Anders
    Thorell, Anders
    Division of Surgery, Department of Clinical Sciences, Danderyd Hospital, Karolinska Institutet, Stockholm, Sweden; Department of Surgery, Ersta Hospital, Stockholm, Sweden.
    Näslund, Ingmar
    Department of Surgery, Faculty of Medicine and Health, Örebro University, Örebro, Sweden.
    Closure of mesenteric defects in laparoscopic gastric bypass: a multicentre, randomised, parallel, open-label trial2016In: The Lancet, ISSN 0140-6736, E-ISSN 1474-547X, Vol. 387, no 10026, p. 1397-1404Article in journal (Refereed)
    Abstract [en]

    Background: Small bowel obstruction due to internal hernia is a common and potentially serious complication after laparoscopic gastric bypass surgery. Whether closure of surgically created mesenteric defects might reduce the incidence is unknown, so we did a large randomised trial to investigate.

    Method: This study was a multicentre, randomised trial with a two-arm, parallel design done at 12 centres for bariatric surgery in Sweden. Patients planned for laparoscopic gastric bypass surgery at any of the participating centres were off ered inclusion. During the operation, a concealed envelope was opened and the patient was randomly assigned to either closure of mesenteric defects beneath the jejunojejunostomy and at Petersen's space or non-closure. After surgery, assignment was open label. The main outcomes were reoperation for small bowel obstruction and severe postoperative complications. Outcome data and safety were analysed in the intention-to-treat population. This trial is registered with ClinicalTrials. gov, number NCT01137201.

    Findings: Between May 1, 2010, and Nov 14, 2011, 2507 patients were recruited to the study and randomly assigned to closure of the mesenteric defects (n= 1259) or non-closure (n= 1248). 2503 (99.8%) patients had follow-up for severe postoperative complications at day 30 and 2482 (99.0%) patients had follow-up for reoperation due to small bowel obstruction at 25 months. At 3 years after surgery, the cumulative incidence of reoperation because of small bowel obstruction was signifi cantly reduced in the closure group (cumulative probability 0.055 for closure vs 0.102 for non-closure, hazard ratio 0.56, 95% CI 0.41-0.76, p= 0.0002). Closure of mesenteric defects increased the risk for severe postoperative complications (54 [4.3%] for closure vs 35 [2.8%] for non-closure, odds ratio 1.55, 95% CI 1.01-2.39, p= 0.044), mainly because of kinking of the jejunojejunostomy.

    Interpretation: The results of our study support the routine closure of the mesenteric defects in laparoscopic gastric bypass surgery. However, closure of the mesenteric defects might be associated with increased risk of early small bowel obstruction caused by kinking of the jejunojejunostomy.

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