[Summary text]
Study design: Randomized controlled trial
Study grouping: Parallel group
Open Label:
Cluster RCT:
Baseline Characteristics
Defects closed
Defects not closed
Included criteria: Primary laparoscopic gastric bypass
Excluded criteria: Revisional bariatric surgery
Pretreatment: Ingen
Intervention Characteristics
Defects closed
Defects not closed
Admission due to abdominal pain
Reoperation
Quality of Life
Chronic abdominal pain
Sponsorship source: ?
Country: USA
Setting:
Comments: Ethicon and Covidien
Authors name: Roses U, Ahmed S, Leva N, Garg T, Rives H et al
Institution: Divission of bariatric and minimal invasive surgery of Standford Hospital and Clinics
Email: morton@stanford.edu
Address: 300 Pasteur Drive, Stanford
V Kristiansen on 13/03/2016 02:47
Interventions
Alle 105 patienter fik lukket Petersens space.Intervention var +/- lukning af defekten under JJ anastomosen
V Kristiansen on 13/03/2016 02:53
Outcomes
105 patienter indgik i stuet, 50 med lukning af defekt og 55 uden lukning.Der er opfølgning på 48 med lukning og 54 uden lukning.Den ene patient med internt hernie er beskrevet under JJ anastomosen
Study design: Randomized controlled trial
Study grouping: Parallel group
Open Label:
Cluster RCT:
Baseline Characteristics
Defects closed
Defects not closed
Included criteria: All patients met the criteria for bariatric surgery as recommended by the Swedish National Board of Health and Welfare (body-mass index [BMI] ≥35 kg/m²) and written consent.
Excluded criteria: Conversion to open surgery prior to the randomizationPatients not giving a written consent (Clinical trials) (Ønsker ikke at deltage. 60 patienter)
Pretreatment: 60 patienter i gruppen lukning af defekt udgik9 patienter i gruppen uden lukning udgik
Intervention Characteristics
Defects closed
Defects not closed
Admission due to abdominal pain
Reoperation
Quality of Life
Chronic abdominal pain
Sponsorship source: Orebro County Council, Stockholm City Council and the Erling-Persson Family Foundation
Country: Sweden
Setting:
Comments: Multi center
Authors name: Erik Stenberg, Eva Szabo, Göran Ågren, Johan Ottosson, Richard Marsk, Hans Lönroth, Lars Boman, Anders Magnuson, Anders Thorell , Ingmar Näslund
Institution: Department of Surgery, Faculty of Medicine and Health, Örebro University Hospital, Örebro SE-70185
Email: erik.stenberg@regionorebrolan.se
Address: Department of Surgery, Faculty of Medicine and Health, Örebro University Hospital, Örebro SE-70185, Sweden
V Kristiansen on 14/03/2016 05:29
Study Design
Multi center, 12 centre.Ikke alle centre var med i hele perioden og alle læger.Intension-to-treat analyse.Ikke blindet for behandler og patient.
V Kristiansen on 15/03/2016 01:09
Outcomes
2 års follow up Lukning af defekter Ikke lukning af defekterObstruktion af JJ anastomosen 16 5Internt hernie 28 91Diag. laparoskopi p gr a smerter, men uden hernie 30 27Alle data er på operations reg. og ikke indl. reg.Diag internt hernie er diff.
Wrong study design
Wrong study design
Wrong study design
Selection bias (biased allocation to interventions) due to inadequate generation of a randomised sequence
Selection bias (biased allocation to interventions) due to inadequate concealment of allocations prior to assignment
Performance bias due to knowledge of the allocated interventions by participants and personnel during the study
Detection bias due to knowledge of the allocated interventions by outcome assessors
Attrition bias due to amount, nature or handling of incomplete outcome data
Reporting bias due to selective outcome reporting
Bias due to problems not covered elsewhere in the table
Describe the method used to generate the allocation sequence in sufficient detail to allow an assessment of whether it should produce comparable groups.
Judgement Comment: random nummer
Quote: "Randomisation was done by use of a computerised random numbers list generated by the Department of Clinical Epidemiology and Biostatistics at Örebro University (Örebro, Sweden). Patients were randomly assigned in a 1:1 ratio, with permuted blocks of diff erent sizes, stratifi ed by centre."
Describe the method used to conceal the allocation sequence in sufficient detail to determine wether intervention allocations could have been foreseen in advance of, during, enrolement.
Judgement Comment: "random number table"
Quote: "Randomisation was done by use of a computerised random numbers list generated by the Department of Clinical Epidemiology and Biostatistics at Örebro University (Örebro, Sweden). Patients were randomly assigned in a 1:1 ratio, with permuted blocks of diff erent sizes, stratifi ed by centre. As decided"
Describe all measures used, if any to blind study participants and personnel from knowledge of which intervention a participant received. Provide any information relating to whether the intended blinding was effective.
Judgement Comment: Personalet er ikke blindet og formentlig gælder dette også for patienten
Judgement Comment: No blinding
Quote: "Because of ethical concerns in the study design, the study"
Describe all measures used, if any to blind outcome assessors from knowledge of which intervention a participant received. Provide any information relating to whether the intended blinding was effective.
Judgement Comment: No blinding
Quote: "online February 16, 2016 http://dx.doi.org/10.1016/S0140-6736(15)01126-5 <b>was not blinded after the operation. This design might aff ect the interpretation of clinical symptoms and thus the handling of endpoints.</b> To ensure that a uniform"
Describe the completeness of outcome data for each main outcome, including attrition and exlusions from the analysis. State whether attrition and exclusions were reported, the numbers in each intervention group (compared with total randomized participants), reasons for attrition/exclusions where reported, and any re-inclusions in analyses performed by the review authors.
Judgement Comment: 75% after 12 months, 100% after 36 months
Quote: "As registered in SOReg, 2503 (99·8%) of 2507 patients had clinical follow-up on day 30, 2439 (97%) had follow- up at 1 year, and 2245 (90%) had follow-up at 2 years. With additional data about abdominal surgery from the Swedish patient register, follow-up for reoperations for small bowel obstruction at Dec 31, 2013 (at least 25 months after surgery for all participants), covered 2482 (99%) of 2507 participants. Five individuals did not have an address in Sweden at this time and were deemed to be lost to follow-up after their last recorded follow-up visit. 20 individuals (1%) died during the follow-up period, with six dying from accident or suicide, three from cardiovascular disease, three from malignant disease, one from infectious disease, one from incarcerated port-site hernia, one from pulmonary disease, and fi ve from other or unknown causes."
State how the possibility of selective outcome reporting was examined by the review authors and what was found.
Judgement Comment: No study protocol reference
State any important concerns about bias not addressed in the other domains in the tool. If particular questions/entries were re-specified in the review's protocol, responses should be provided for each question/entry.
Judgement Comment: Funding unclear, however, possibly there is no other funding sources tahn the mention Stanford Bariatric and Metabolic Interdisciplinary Clinic
Judgement Comment: No inoformation