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Single anastomosis sleeve jejunal bypass compared to sleeve gastrectomy and to one anastomosis gastric bypass - Trial PACTR202310506240189

Access comprehensive clinical trial information for PACTR202310506240189 through Pure Global AI's free database. This Phase 3 trial is sponsored by Cairo University Hospital and is currently Completed. The study focuses on Surgery.

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PACTR202310506240189
Phase 3
Completed
procedure
Trial Details
Pan Africa Clinical Trials Registry โ€ข PACTR202310506240189
Pure Global
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Single anastomosis sleeve jejunal bypass compared to sleeve gastrectomy and to one anastomosis gastric bypass

Study Focus

Surgery

procedure

Sponsor & Location

Cairo University Hospital

Moheb Fikry Bebawy

Egypt

Timeline & Enrollment

Phase 3

Dec 31, 2021

Apr 30, 2023

Summary

Single anastomosis sleeve jejunal (SASJ) bypass is a modification of single anastomosis sleeve ileal (SASI) using a shorter biliopancreatic limb length compared to SASI to prevent long-term nutritional complications. The SASJ bypass appears to be safer than the SASI procedure in patients with excessive weight loss and nutritional deficiencies and is simpler due to its improved surgical ergonomics. The aim of the study was to assess the safety and efficacy of SASJ regarding weight loss, quality of life, resolution of obesity-related diseases, and gastro esophageal reflux disease.This study included 90 morbidly obese patients seeking weight loss surgery at Cairo University Hospitals. Laparoscopic sleeve gastrectomy was done for 30 patients, laparoscopic one anastomosis gastric bypass (OAGB) was done for 30 patients and laparoscopic SASJ bypass was done for 30 patients. Data obtained from patients were compared regarding the three different techniques. OAGB was associated with more excess body weight loss at 3, 6, and 12 months compared with the other two procedures. The mean score for SASJ was 28.2, 47.66, and 64.33; for OAGB was 31, 47.7, and 67; and for sleeve gastrectomy was 29.8, 46.2, and 65.6, respectively. All patients in the three groups experienced some degree of improvement regarding obesity related co-morbidities (statistically insignificant difference). When applying the GIQLI in the three groups it showed better results for SASJ patients than the other two procedures with statistical significance results (P value <0.001, < 0.001, <0.001). SASJ is a safe procedure with comparable results to sleeve gastrectomy and OAGB in terms of weight loss and resolution of obesity related comorbidities; however, SASJ was associated with significantly better results regarding GIQL and reflux with the advantage of being simple and reversible procedure.

ICD-10 Classifications

Other surgical procedures
Surgical procedure, unspecified
During surgical operation
During surgical operation
During surgical operation

Data Source

Pan Africa Clinical Trials Registry

PACTR202310506240189

Non-Device Trial