Sharma 2013.
| Methods |
Parallel randomised controlled clinical trial Randomisation ratio: not reported Superiority design |
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| Participants |
Inclusion criteria: recruited patients all needed to meet the NIH criteria for Bariatric surgery (BMI over 40 or greater than 35 with at least one comorbidity) Exclusion criteria: none reported Diagnostic criteria: BMI > 40, or > 35 with ≥ 1 comorbidity |
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| Interventions |
Number of study centres: 1 Treatment before study: none reported Titration period: not applicable Interventions: 1. Laparoscopic gastric imbrication 2. Laparoscopic sleeve gastrectomy |
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| Outcomes | Outcomes reported in abstract of publication: weight loss; complications and additional operative procedures | |
| Study details |
Run‐in period: not reported Study terminated before regular end: no |
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| Publication details |
Language of publication: English Funding: not reported (authors declared they had no conflicts of interests) Publication status: unpublished manuscript (pending journal decision) |
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| Stated aim for study | Quote: 'To compare the surgical outcome after sleeve gastrectomy and gastric imbrication in patients with morbid obesity' (Narwaria 2011) | |
| Notes | ‐ | |
| 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: no information provided |
| Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Comment: outcome assessors were blinded to allocation group for the first year, but unblinded for years 2 and 3. However also stated (in Discussion) that ‘the third party administrator who followed the patients for weight‐loss outcomes also randomized the patients. We tried to account for this by having two different people perform each function and not having them communicate with one another about the study’ |
| Incomplete outcome data (attrition bias) Weight | Unclear risk | Comment: per protocol analysis. The authors imply that a patient flow chart is available but it was not provided with the manuscript. Without this, numbers of dropouts, and any reasons for dropouts, are not known. Stated 100% follow up but also dropouts and crossovers occurred – no reasons given Comment: baseline and year 2 data not reported for EWL |
| Selective reporting (reporting bias) | Unclear risk | Comment: the manuscript focuses on weight outcomes; 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 | High risk | Quote: "The one leak in our LGI group can be directly attributed to our lack of experience with the LGI. We are certain if our study had been conducted by one of the prominent LGI groups around the world the leak we experienced would have been avoided" Comment: a source of bias if the surgeons were consistently less skilled at gastric imbrication than sleeve gastrectomy but this only appears to have resulted in a serious outcome in one operation |