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

NCT07038148 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 11

Last updated 2025-06-26

No results posted yet for this 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.

Conditions

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

Interventions

PROCEDURE

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.

Sponsors & Collaborators

  • Kasr El Aini Hospital

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-01-25
Primary Completion
2026-01-25
Completion
2026-01-30

Countries

  • Egypt

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07038148 on ClinicalTrials.gov