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

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.

Study Overview

• Status: Recruiting
• Conditions: the Focus of the Study is to Assees Efficacy of Stapled Revision of Gastric Bypass to Sleeve Gastrectomy
• Intervention / Treatment: Procedure: Stapled reversal of gastric bypass to sleeve gastrectomy utilising stapling technique.

Detailed Description

Objectives: To study efficacy, safety, and patient outcomes following laparoscopic gastric bypass conversion to sleeve gastrectomy.

Study population & Sample size :

Adult patients undergoing single-stage laparoscopic stapled conversion of gastric bypass to sleeve gastrectomy in Kasr Alainy Sample size: 11 patients Study Design: This is a prospective single-arm clinical trial.

Methods: Patients who will attend our bariatric outpatient clinic will be enlisted according to inclusion criteria. A detailed history of anthropometric measures, chronic diseases, and previous surgeries will be recorded. After patient education, preoperative routine labs and imaging will be performed.

A preoperative 3D gastric volumetry CT scan will be performed to all patients included in this study.

The procedure will consist of converting the gastric bypass to a sleeve gastrectomy using a stapling technique.

The average length of hospital stay will be included. Follow up of nutritional status will be done using laboratory parameters (Hb, Ferritin, Vitamin D, Zn, Mg, serum Albumin, Calcium) in 3 months and 6 months postoperatively, quality of life will be assessed using bariatric quality of life index in 3 months and 6 months postoperatively.

Patient weight will be documented monthly to evaluate weight regain, GERD symptoms will be assessed using GERD score in 3 months and 6 months postoperatively.

Possible Risk (s) to study population:

1. Postoperative pain.
2. Postoperative nausea and vomiting.
3. Bleeding
4. Anastomotic leakage
5. Stricture

Outcome parameters:

• Primary outcomes

  1. Improvement of nutritional status.
  2. Weight regain.

• Secondary outcome parameters

  1. Quality of life
  2. GERD symptoms

Statistical analysis plan:

Data analysis packages will be SPSS version 21. Qualitative data will be presented by number and percentage, quantitative data will be presented by mean, standard deviation, median, and interquartile range.

Parametric and non-parametric tests of significant will be done (chi-square, student t-test, and Mann-Whitney test).

Correlation analysis tests and regression will be done. The level of significance was set at p equal to or below 0.05.

• Study Type: Interventional
• Enrollment (Estimated): 11
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Associate Professor of General and Laparosocpic Surgery; Phone Number: +201111577188; Email: a.abd.elsalam@kasralainy.edu.eg

Study Locations

• Egypt
  • Old Cairo
    • Cairo, Old Cairo, Egypt, 11956
      • Recruiting
      • Kasr Alainy Medical School, Cairo University
      • Contact: Maher Fawzy, Doctorate; Phone Number: +201222166937; Email: kasralainyrec@kasralainy.edu.eg
      • Sub-Investigator: Ahmed M Ghobashy, Doctorate
      • Sub-Investigator: Ahmed M Abdelatif, Doctorate
      • Sub-Investigator: Ahmed Y Khaled, Doctor

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Candidates of several of bypass to sleeve; This interventional study with a single arm assesses the effectiveness and safety of converting gastric bypass to sleeve gastrectomy using a laparoscopic stapling technique in adults who have complications from earlier gastric bypass procedures. The approach entails closing the prior gastrojejunostomy and performing a sleeve gastrectomy with a stapling method. The outcomes measured will include enhancements in nutritional status, weight regain, quality of life, and symptoms of GERD over a follow-up period of 6 months.

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Nutritional Status	nutritional status of patient will be assessed by general examination, assessment of lower limb edema, serum albumin and hemoglobin	one year
Weight Regain	The initial weight at the time of the procedure will be measured in kg, and at follow-up, it will be reassessed at three, six, and twelve months. Weight assessment will be part of the BMI assessment in kg/m2	one year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Quality of Life	The Short Form 36 (SF-36) questionnaire will be used to assess quality of life and overall health status.	one year
GERG symptoms	GERD symptoms will be assessed at three, six, and twelve months of follow-up. The GERD-Health Related Quality of Life (GERD-HRQL) Questionnaire will be used in this study.	One year

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Possible Risks	Post operative pain.; Post operative nausea and vomiting.; Bleeding; Anastomotic leakage; Stricture	One year

Collaborators and Investigators

• Sponsor: Kasr El Aini Hospital

Publications and helpful links

General Publications

• Sjostrom L, Lindroos AK, Peltonen M, Torgerson J, Bouchard C, Carlsson B, Dahlgren S, Larsson B, Narbro K, Sjostrom CD, Sullivan M, Wedel H; Swedish Obese Subjects Study Scientific Group. Lifestyle, diabetes, and cardiovascular risk factors 10 years after bariatric surgery. N Engl J Med. 2004 Dec 23;351(26):2683-93. doi: 10.1056/NEJMoa035622.
• Okut G, Turgut E, Kaplan K, Sumer F, Kayaalp C. Can revision of RYGB to sleeve gastrectomy be a solution to inadequate weight loss treatment? Cir Cir. 2022;90(S1):25-30. doi: 10.24875/CIRU.21000458.

Study record dates

Study Major Dates

• Study Start (Actual): January 25, 2025
• Primary Completion (Estimated): January 25, 2026
• Study Completion (Estimated): January 30, 2026

Study Registration Dates

• First Submitted: January 25, 2025
• First Submitted That Met QC Criteria: June 17, 2025
• First Posted (Actual): June 26, 2025

Study Record Updates

• Last Update Posted (Actual): June 26, 2025
• Last Update Submitted That Met QC Criteria: June 17, 2025
• Last Verified: January 1, 2025

More Information

Terms related to this study

• Other Study ID Numbers: N-8-2025

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No