Himpens 2006.
| Methods |
Parallel randomised controlled clinical trial Randomisation ratio: not reported Superiority design |
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| Participants |
Inclusion criteria: only inclusion criteria mentioned are candidates for laparoscopic restrictive operation Exclusion criteria: not reported Diagnostic criteria: not reported (baseline BMI range 30‐53) |
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| Interventions |
Number of study centres: not reported but appears to be a single centre Treatment before study: prior to surgery, 6 GB and 8 SG patients experienced GERD and needed daily treatment with proton pump inhibitor (unclear whether treatment was given before or after randomisation). Titration period: n/a Interventions: 1. Laparoscopic adjustable gastric band (LAGB) 2. Laparascopic isolated Sleeve Gastrectomy (LISG). |
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| Outcomes | Outcomes reported in abstract of publication: co‐morbidities, complications and additional operative procedures, weight loss | |
| Study details |
Run‐in period: none reported Study terminated before regular end: no |
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| Publication details |
Language of publication: English Funding: not reported Publication status: peer review journal |
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| Stated aim for study | Quote from publication: “to compare the laparoscopic adjustable GB and laparoscopic isolated SG in terms of weight loss, feeling of hunger, craving for eating sweets, gastroesophageal reflux disease (GERD), complications and re‐operations, reporting the results after 1 year and 3 years” (Himpens 2006, p. 1451) | |
| Notes | BMI: body mass index; GB: laparoscopic adjustable gastric banding; GERD: gastroesophageal reflux disease; LAGBL: laparoscopic adjustable gastric band; LISG: laparoscopic isolated sleeve gastrectomy; n/a: not applicable; SG: solated sleeve gastrectomy | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | Comment: states patients operated consecutively and randomly assigned. No details of randomisation sequence reported |
| Allocation concealment (selection bias) | Unclear risk | Comment: no details reported |
| Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Comment: no details reported |
| Incomplete outcome data (attrition bias) Weight | Unclear risk | Comment: states that 80 randomised, 40 in each group. No discussion of any attrition or exclusions, appears to be no losses at 3 years but unable to check as numbers not presented in any details of weight loss results |
| Incomplete outcome data (attrition bias) Comorbidities | Unclear risk | Comment: GERD outcomes ‐ all numbers were reported, but data were statistically analysed by subgroup for this outcome ‐ those without GERD at baseline to see if it appeared, those with it at baseline to see if it disappeared. |
| Selective reporting (reporting bias) | Unclear risk | Comment: reports data on outcomes listed in methods, but study protocol not available, Only reports mean change and range, not standard deviations |
| Other bias | Unclear risk | Comment: the characteristics of the patients were reported to be similar for the two groups, although states medians and ranges were performed unclear what the reason is for this. Insufficient information to assess whether an important risk of bias exists |