Comparing Revisional Laparoscopic Roux-en-Y Gastric Bypass Versus Ringed Revisional Roux-en-Y Gastric Bypass After Laparoscopic Sleeve Gastrectomy

NCT07436013 | Recruiting

• 1 other identifier: Revisional ringed roux vs roux
• Study Type: interventional
• Target: 240
• Locations: 1 country
• Sites: 1

Brief Summary

Obesity remains a major global health challenge, with rising prevalence and significant metabolic, cardiovascular, and gastrointestinal comorbidities. Laparoscopic sleeve gastrectomy (LSG) has emerged as the most widely performed bariatric procedure due to its technical simplicity and satisfactory short- to mid-term results. However, a proportion of patients experience suboptimal weight loss, recurrent weight gain, or both. In this study, patients with recurrent weight gain of maximum weight loss or suboptimal weight loss or both following sleeve gastrectomy were included. Suboptimal weight loss is defined as total weight loss (TWL) of less than 20% of the preoperative weight and/or excess weight loss (EWL) of less than 50%, measured at least 12-18 months after the primary sleeve gastrectomy. Recurrent weight gain after sleeve gastrectomy is defined as an increase of ≥20% of the maximum weight loss (from nadir weight) or an increase in BMI of \>5, measured at least 24 months after the primary procedure.

Conditions

Revisional Bariatric Surgery

Keywords

Gastric Bypass; Revisional Laparoscopic Roux-en-Y; Ringed Revisional Roux-en-Y; Weight Loss; BAROS Score; Quality of Life; Food Tolerance

Outcome Measures

Primary Outcomes (1)

• Percent EWL (excess weight loss) and percent TWL (Total weight loss)

  relative to both the pre-primary surgery (sleeve gastrectomy) weight and the pre-revisional surgery (RYGB or ringed RYGB) weight by kilograms.

  1, 2, 3, 4, and 5 years postoperatively

Secondary Outcomes (18)

• Comorbidity resolution

  6 months, 1,2,3,4 and 5 years postoperatively

• Comorbidity resolution

  6 months, 1,2,3,4 and 5 years postoperatively

• Comorbidity resolution

  6 months, 1,2,3,4 and 5 years postoperatively

• Quality of Life (SF-36)

  1, 2, 3, 4, and 5 years postoperatively

• Food tolerance (FTQ)

  6 months, 3 and 5 years postoperatively.

Study Arms (2)

Group non banded

ACTIVE COMPARATOR

Standard revisional RYGB

Procedure: Standard revisional RYGB

Group banded

ACTIVE COMPARATOR

Revisional Banded RYGB

Procedure: Revisional Banded RYGB

Interventions

Standard revisional RYGB PROCEDURE

* Small gastric pouch (\~30 mL). * 100-150 cm alimentary limb, 50 cm biliopancreatic limb.

Group non banded

Revisional Banded RYGB PROCEDURE

* Standard RYGB as above. * Placement of a silastic ring (5.5-7.0 cm circumference) around the gastric pouch, \~2 cm above the gastrojejunal anastomosis.

Group banded

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults aged 18-65 years.
• Patients who experienced recurrent weight gain, suboptimal weight loss, or both within 12-24 months or more following sleeve gastrectomy.
• Eligible and fit for bariatric surgery.
• Willing to provide informed consent and adhere to follow-up.

You may not qualify if:

• Severe psychiatric disorders or uncontrolled substance abuse.
• Pregnancy or planned pregnancy within 2 years post-surgery.
• Chronic steroid use or immunosuppressive therapy.
• Active malignancy or history of gastrointestinal cancer.
• Severe cardiac or pulmonary disease precluding surgery.
• Uncontrolled endocrine disorders (other than T2DM).
• Inability to comply with follow-up or protocol requirements.

Sponsors & Collaborators

• General Committee of Teaching Hospitals and Institutes, Egypt: lead

Study Sites (1)

The surgical department of Medical Research Institute Hospital, Alexandria University

Alexandria, Alexandria Governorate, 21531, Egypt

RECRUITING

MeSH Terms

Conditions

Weight Loss

Condition Hierarchy (Ancestors)

Body Weight Changes; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Mohamed H Ashour, PhD

CONTACT

00201002600970; dr.mhany@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of General surgery

Study Record Dates

• First Submitted: February 14, 2026
• First Posted: February 27, 2026
• Study Start: March 15, 2026
• Primary Completion (Estimated): March 1, 2031
• Study Completion (Estimated): March 1, 2031
• Last Updated: April 29, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share

Locations

EG (1)