Vix 2013.
| Methods |
Parallel randomised controlled clinical trial Randomisation ratio: not reported Inferiority design |
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| Participants |
Inclusion criteria: not reported other than patients meeting the criteria for bariatric surgery Exclusion criteria: BMI < 40 and > 60; patient preference for a specific procedure; inability to provide informed consent; age < 18 or > 60 years; previous upper or lower gastrointestinal surgery; and hiatal hernia > 2 cm. Diagnostic criteria: BMI 40‐60 |
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| Interventions |
Number of study centres: 1 Treatment before study: patients presenting with vitamin D deficiency were supplied with cholecalciferol in the preoperative (and also postoperative period) and continued until normalization was achieved. Titration period: n/a Interventions: 1. Laparoscopic Roux‐en‐Y gastric bypass 2. Laparoscopic sleeve gastrectomy |
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| Outcomes | Outcomes reported in abstract of publication: weight loss | |
| Study details |
Run‐in period: not applicable Study terminated before regular end: no |
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| Publication details |
Language of publication: English Funding: not reported Publication status: peer reviewed journal |
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| Stated aim for study | Quote: "To assess postoperative outcomes of sleeve gastrectomy (SG) versus Roux‐en‐Y gastric bypass (RYGB)" | |
| Notes | n/a: not applicable | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | Comment: no information provided |
| Allocation concealment (selection bias) | Unclear risk | Comment: stated (Surg Endosc paper) that patients were assigned to group by sealed‐envelope randomisation. Stated (Obes Res paper) “Randomization was achieved using closed envelopes. For the first 100 patients, 120 envelopes were prepared, with an estimated minimum of 10 % failure rate after randomization to the allocated procedure for specific French health insurance issues. Patients in which the randomization procedure failed after medical adviser decision‐making were excluded from the study.” Comment: Neither statement gives sufficient details to judge low risk of bias (e.g. unclear whether envelopes were opaque). |
| Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Comment: no information provided |
| Incomplete outcome data (attrition bias) Weight | Unclear risk | Comment: there are discrepancies in the reported attrition rate between the two linked papers. Obes Surg paper states 8 were lost to follow up of which 7 were in the LSG group (13% of those randomised); Surg Endosc paper states only 1 per group was lost to follow up. Reason given for loss to follow up was lost contact. |
| Selective reporting (reporting bias) | Unclear risk | Comment: results were reported for all outcomes mentioned in the methods; a study protocol with a priori definitions would help to clarify risk of reporting bias |
| Other bias | Low risk | Comment: no evidence of other bias |
Note: where the judgement is 'Unclear' and the description is blank, the study did not report that particular outcome. ITT: intention‐to‐treat QoL: quality of life RCT: randomised controlled trial