Randomized double-blinded trial of laparoscopic gastric imbrication v laparoscopic sleeve gastrectomy at a single Indian institution

Abstract

Background: Currently, there is a debate whether the laparoscopic gastric imbrication (LGI) offers similar weight loss when compared to the laparoscopic sleeve gastrectomy (LSG). On the surface, they seem to offer similar-sized stomachs after the procedures are performed. We chose to perform a randomized double-blinded trial to see if similar-sized pouches result in similar types of weight loss. Our belief was that sleeve gastrectomy would offer at least a 10% better weight loss over a 3-year period.

Methods: Thirty patients were randomized to one of two arms. The patients and the third party administrator following the patients were blinded as to which procedure was chosen. The surgeon had full knowledge of the patients' surgery throughout the treatment. The decision of which arm to place them was made by a single employee of the third party administrator and not shared with the employees following the patients. Patients were then followed for 3 years.

Results: There were no differences in weight, age, or BMI preoperatively. There were no differences between the two groups at any follow-up time point from 6 months to 3 years. Follow-up was 100%.

Conclusion: Due to the large standard deviations present in both groups, there was no statistical difference between either of the groups in terms of weight loss.