Clinical trial

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

Recruiting now · Not applicable · 1 countries · Registry ID NCT07436013

Recruiting nowNot applicableInterventional

What this study is about

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.

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age18 Years to 65 Years

SexAll

Healthy volunteersNot accepted

ConditionRevisional Bariatric Surgery

Full registry criteria

Inclusion Criteria: * 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 Criteria: * 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.

Treatments and study arms

Standard revisional RYGB

Procedure

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

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.

Primary outcomes

Percent EWL (excess weight loss) and percent TWL (Total weight loss)1, 2, 3, 4, and 5 years postoperatively

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

Study locations

1 locations were listed when this page was built. The first 40 are shown.

The surgical department of Medical Research Institute Hospital, Alexandria University🇪🇬 Alexandria, Alexandria Governorate, Egypt

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Mohamed H Ashour, PhDContact

Email · Call 00201002600970