Karamanakos 2008.
| Methods |
Parallel randomised controlled clinical trial Randomisation ratio: not reported Superiority design |
|
| Participants |
Inclusion criteria: stated only that patients had BMI ≤ 50 and were on the waiting list pool for bariatric surgery. In response to a request for further information, the author clarified that the BMI inclusion criteria were 40 to 50 and 35 to 50 for patients with type 2 diabetes. Exclusion criteria: chronic medical or psychiatric illness, substance abuse, previous gastrointestinal surgery. Diagnostic criteria: BMI 40 to 50, and 35 to 50 for patients with type 2 diabetes. |
|
| Interventions |
Number of study centres: not reported but appears to be a single centre Treatment before study: none reported Titration period: n/a Interventions: 1. Laparoscopic Roux‐en‐Y gastric bypass (LRYGBP) + daily multivitamin and mineral supplementation including intramuscular vitamin B12 (+ daily iron supplement for all premenopausal women – time period of supplementation not stated). 2. Laparoscopic sleeve gastrectomy (LSG) + multivitamin and mineral supplementation for 6 months then according to requirement. |
|
| Outcomes | Outcomes reported in abstract of publication: weight loss, co‐morbidities, complications and additional procedures | |
| Study details |
Run‐in period: none reported Study terminated before regular end: no |
|
| Publication details |
Language of publication: English Funding: not reported Publication status: peer review journal |
|
| Stated aim for study | Quote: “to evaluate and compare the effects of LRYGBP to the effects of LSG … on body weight, appetite and also on ghrelin and PYY levels.” (Karamanakos 2008, p. 402) Quote: "...to compare the mid‐term outcomes in non‐superobese patients undergoing LRYGB and LSG" (Kehagias 2011, p. 1650) |
|
| Notes | BMI: body mass index; LRYGB: laparoscopic Roux‐en‐Y gastric bypass; LSG: laparoscopic sleeve gastrectomy; n/a = not applicable | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Quote from publication: “Computer‐generated random numbers were used to assign the type of surgery” (Kehagias 2011, p. 1651) |
| Allocation concealment (selection bias) | Unclear risk | Quote from publication: "... random numbers were used to assign the type of surgery which was written on a card sealed in a completely opaque envelope" (Kehagias 2011, p. 1651) Comment: unclear whether envelopes sequentially numbered, and when and to whom the information in the envelopes was disclosed |
| Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Quote from publication: "Blinding as to the type of procedure involved the patient and the medical staff and the independent data collector" (Kehagias 2011, p. 1651). Comment: no details were given about the blinding method or whether it may have been broken |
| Incomplete outcome data (attrition bias) Weight | Unclear risk | Comment: for 3‐year follow‐up it is unclear whether dropouts were included in the analysis; reasons for dropout were not reported |
| Incomplete outcome data (attrition bias) Comorbidities | Unclear risk | Comment: unclear whether all comorbidities were reported; timing of some comorbidities inconsistently defined; statistical significance of co‐morbidities reported inconsistently; unclear whether 3 missing patients at year 3 were analysed |
| Selective reporting (reporting bias) | Unclear risk | Comment: outcomes were assessed at 1, 3, 6, 12, 24 and 36 months but only reported yearly Duration of anaesthesia and length of stay were recorded but not reported Minor complications were reported narratively only, not separately by intervention group: Quote from publication: “…minor complications such as acid regurgitation, heartburn and vomiting were present in approximately 20% of LSG group patients during the first six post‐operative months and, in most cases, were not severe” |
| Other bias | Unclear risk | Comment: extent of vitamin supplementation unclear: stated in discussion that LSG group did not require supplementation but implied in methods section that they did receive supplements for at least 6 months. Overall, supplementation was more extensive in LRYGB than LSG group |