RecruitingNot ApplicableNCT07436013

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

A Prospective Randomized Controlled Trial Comparing Revisional Laparoscopic Roux-en-Y Gastric Bypass Versus Ringed Revisional Roux-en-Y Gastric Bypass After Laparoscopic Sleeve Gastrectomy: 5-Year Outcomes on Weight Loss, BAROS Score, Quality of Life, and Food Tolerance


Sponsor

General Committee of Teaching Hospitals and Institutes, Egypt

Enrollment

240 participants

Start Date

Mar 15, 2026

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 YearsMax Age: 65 Years

Inclusion Criteria4

  • 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.

Exclusion Criteria7

  • 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.

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Interventions

PROCEDUREStandard revisional RYGB

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

PROCEDURERevisional Banded RYGB

* 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.


Locations(1)

The surgical department of Medical Research Institute Hospital, Alexandria University

Alexandria, Alexandria Governorate, Egypt

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NCT07436013


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