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Clinical Trials in Egypt / NCT07038148
Recruiting Not applicable

Exploring the Efficacy of Single-stage Stapled Conversion of Gastric Bypass to Sleeve Gastrectomy, More Leak?

NCT07038148 · tracked via the Priya Life Science Egypt tracker
Phase
Not applicable
Started
2025-01-25
Last updated
2025-06-26

Condition(s) studied

the Focus of the Study is to Assees Efficacy of Stapled Revision of Gastric Bypass to Sleeve Gastrectomy

Investigational drug(s) / intervention(s)

Stapled reversal of gastric bypass to sleeve gastrectomy utilising stapling technique.

Stapled reversal of gastric bypass to sleeve gastrectomy utilising stapling technique.: This research entails a single-stage laparoscopic conversion of gastric bypass to sleeve gastrectomy. The procedure entails the closure of the gastrojejunostomy with an endo-stapler and the reconstruction of the stomach by resecting along the greater curvature to create a sleeve gastrectomy. An intraoperative leak test will be conducted using methylene blue. Patients are monitored postoperatively for at least 24 hours, with subsequent assessments of nutritional status, weight, gastroesophageal reflux disease (GERD) symptoms, and quality of life at 3 and 6 months.

Study summary

Laparoscopic gastric bypass - including both Roux-en-Y gastric bypass (RYGB) and one anastomosis gastric bypass (OAGB) - is one of the most frequently performed procedures. However, as the number of gastric bypass surgeries increases, complications are being reported more often. While most post-bypass complications can be managed non-surgically, a small number of persistent cases may require a reversal to normal anatomy or conversion to another procedure.

Many patients who experience severe complications from gastric bypass are reluctant to undergo a reversal to normal anatomy due to fears of regaining weight. As a result, converting to another type of surgery becomes a more logical alternative.

Complications requiring conversion are numerous and negatively affect the quality of life, such as retrograde intussusception, weight regain, intractable dumping syndrome, and nutritional deficiencies. The high cost of obligatory postoperative vitamins is a potential cause of conversion especially in low-income countries.

The conversion procedure is technically demanding and has a relatively higher rate of postoperative complications, making it less commonly performed. Additionally, limited data is available regarding the procedure and its long-term outcomes, making it an unexplored sea of hope for people who wish to manage intractable complications of gastric bypass and maintain weight loss.

Eligibility

Sex
ALL
Min age
18 Years
Max age
70 Years
Healthy volunteers
No
Inclusion Criteria: * Age between 18-70 * Adult patients undergoing single-stage laparoscopic stapled conversion of gastric bypass to sleeve gastrectomy. * Patients accept to sign an informed consent and will commit to follow-up. Exclusion Criteria: * Patients with reversal gastric bypass to normal anatomy. * Patient with uncontrolled systemic disease. * Patients with active psychological disorders. * Patients with active substance abuse. * Patients with intra-operative technical difficulties hindering the conversion of gastric bypass to sleeve gastrectomy. * Patients refusing to sign an informed consent.

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Kasr Alainy Medical School, Cairo University Cairo Old Cairo Recruiting

More Kasr El Aini Hospital trials in Egypt

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07038148 on ClinicalTrials.gov ↗ ← All trials in Egypt