Actively Recruiting

Phase Not Applicable
Age: 18Years - 60Years
All Genders
Healthy Volunteers
ID05608772

Conversion of Failed Sleeve Gastrectomy Due to Weight Regain to SADI-S, RYGB or OAGB

Led by General Committee of Teaching Hospitals and Institutes, Egypt · Updated on 2025-09-16

234

Participants Needed

1

Research Sites

4 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

This research aims to compare three types of revisional surgeries—Single anastomosis duodeno-ileal bypass (SADI-S), Roux-en-Y gastric bypass (RYGB), and one anastomosis gastric bypass (OAGB)—to find which provides the best weight loss and lowest complications after a failed laparoscopic sleeve gastrectomy (LSG). The study also looks at nutritional lab status and whether related health problems improve after weight loss. The trial involves 234 patients randomly assigned to one of the three procedures to evaluate outcomes in a controlled setting. Participants who have had a primary LSG and experienced weight regain will receive one of the three revisional surgeries. Each participant is assigned randomly to undergo SADI-S, RYGB, or OAGB as a follow-up surgery. These procedures have different anatomical effects, and the study explores their comparative impacts on weight loss and health. The trial includes follow-ups at 2 weeks, 6 weeks, 3 months, 6 months, 12 months, and 24 months to monitor progress and complications. During the study, participants will be assessed for early and late surgical complications, excess body weight loss percentage, food tolerance, nutritional levels including albumin, protein, anemia, and calcium, reflux incidence, quality of life, pain, and various metabolic biomarkers such as GLP1, leptin, peptide YY, ghrelin, and insulin. These measurements will occur at multiple time points up to 24 months after surgery. The total participation duration is about two years, with ongoing monitoring to understand the benefits and risks of each revisional procedure.

CONDITIONS

Brief Title

Conversion to SADI-S, RYGB or OAGB After Failed Sleeve

Who Can Participate

Age: 18Years - 60Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Undergone primary laparoscopic sleeve gastrectomy in the past
  • Experienced weight regain defined as any increase in weight above the lowest point reached after surgery
  • BMI at the time of revisional surgery around 45 kg/m2
  • Weight regain defined as BMI exceeding 35 after bariatric surgery
  • With or without gastroesophageal reflux disease (GERD) grade A or B
Not Eligible

You will not qualify if you...

  • Patients with GERD grade C or higher according to Los Angeles (LA) classification
  • Did not follow preoperative consultation
  • Unable to provide signed informed consent

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

1
2
3
+1

Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Surgery

Duration - Day of surgery

Participants undergo a revisional surgical procedure to convert a failed sleeve gastrectomy to one of three types of bariatric surgery: SADI-S, RYGB, or OAGB.

1 surgery visit (in-person)

Surgery and Immediate Post-operative Care

Duration - Up to 6 weeks

Participants receive immediate post-operative care and monitoring for early complications following their revisional surgery.

Visits during the first 6 weeks post-surgery (in-person)

Post-operative Follow-up

Duration - Up to 24 months

Participants attend follow-up visits to assess weight loss, nutritional status, quality of life, and late complications after surgery.

Visits at 3, 6, 12, and 24 months post-surgery (in-person)

Trial Site Locations

Total: 1 location

1

Madina Women's Hospital

Alexandria, Alexandria Governorate, Egypt, 21531

Actively Recruiting

Loading map...

Research Team

B

Bart Torensma, PHD

M

Mohamed Ashour, MD

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

3

Similar Trials

9-Step Magnetic Assisted Conversion From Sleeve Gastrectomy ...

Bariatric Surgery Candidate

Actively Recruiting

1 location

A Multi-center, Single-dose, Parallel-group, Open-label Stud...

Diabetes Mellitus

Actively Recruiting

1 location

Frequently Asked Questions

Have more questions? Get in touch with our team for quick support

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here

Published Research Related To This Trial

One Anastomosis/Mini Gastric Bypass (OAGB-MGB) as revisional bariatric surgery after failed primary adjustable gastric band (LAGB) and sleeve gastrectomy (SG): A systematic review of 1075 patients.

Chetan D Parmar, Jonathan Gan, Christine Stier...

https://pubmed.ncbi.nlm.nih.gov/32738545

Mini/One Anastomosis Gastric Bypass Versus Roux-en-Y Gastric Bypass as a Second Step Procedure After Sleeve Gastrectomy-a Retrospective Cohort Study.

Sonja Chiappetta, Christine Stier, Oliver Scheffel...

https://pubmed.ncbi.nlm.nih.gov/30542828