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

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.

Study Overview

• Status: Recruiting
• Conditions: Revisional Bariatric Surgery
• Intervention / Treatment: Procedure: Standard revisional RYGB; Procedure: Revisional Banded RYGB

Detailed Description

Roux-en-Y gastric bypass (RYGB) is considered the procedure of choice for revisional bariatric surgery following failed LSG, offering both restrictive and malabsorptive mechanisms and effectively controlling reflux symptoms. Despite its success, long-term weight regain may still occur due to gradual dilation of the gastric pouch or gastrojejunal anastomosis. To mitigate this, the incorporation of a fixed ring or silastic band around the gastric pouch-known as ringed RYGB (R-RYGB)-has been introduced to maintain restriction, prevent pouch enlargement, and enhance long-term weight maintenance.

While B-RYGB has shown promise in primary bariatric procedures, evidence in the revisional setting remains limited and inconclusive. Few studies have systematically compared standard revisional RYGB and ringed revisional RYGB following sleeve gastrectomy, particularly regarding long-term outcomes such as sustained weight loss, food tolerance, quality of life, and comprehensive composite outcomes like the Bariatric Analysis and Reporting Outcome System (BAROS) score.

This prospective randomized controlled trial aims to fill this gap by providing 5-year comparative data on revisional RYGB versus ringed revisional RYGB after sleeve gastrectomy, assessing not only the efficacy in maintaining weight loss but also the broader impact on patient well-being, food tolerance, and overall quality of life.

• Study Type: Interventional
• Enrollment (Estimated): 240
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Mohamed H Ashour, PhD; Phone Number: 00201002600970; Email: dr.mhany@gmail.com

Study Locations

• Egypt
  • Alexandria Governorate
    • Alexandria, Alexandria Governorate, Egypt, 21531
      • Recruiting
      • The surgical department of Medical Research Institute Hospital, Alexandria University
      • Contact: Mohamed H Ashour, PhD; Phone Number: 00201002600970; Email: dr.mhany@gmail.com

Participation Criteria

Eligibility Criteria

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

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Group non banded; Standard revisional RYGB	Procedure: Standard revisional RYGB; Small gastric pouch (~30 mL).; 100-150 cm alimentary limb, 50 cm biliopancreatic limb.
Active Comparator: Group banded; Revisional Banded RYGB	Procedure: Revisional 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Comorbidity resolution	T2DM (type 2 diabetes mellitus) Clinical Remission Criteria (T2DM) The American Diabetes Association (ADA) and other international experts define remission based on glycemic levels in the absence of glucose-lowering medications for at least 3 to 12 months. Complete Remission: HbA1c < 5.7% and Fasting Plasma Glucose (FPG) < 100 mg/dL. Partial Remission: HbA1c between 5.7% and 6.4% and FPG between 100-125 mg/dL. Improvement: A significant reduction in HbA1c (>1%) or FPG (>25 mg/dL), or a substantial decrease in medication dosage (e.g., stopping insulin) without meeting full remission criteria.	6 months, 1,2,3,4 and 5 years postoperatively
Comorbidity resolution	HTN (hypertension) Comparing pre- and postoperative results for hypertension (HTN) involves tracking clinical benchmarks that measure both blood pressure (BP) levels and the intensity of medical therapy required for control. Clinical Metrics for Comparison Blood Pressure Readings: Comparison of mean systolic and diastolic BP. Preoperative levels (typically around 140/90 mmHg) are compared against postoperative follow-up intervals. Medication Load: Tracking the total number of antihypertensive agents (AHMs). A common outcome is the likelihood of complete AHM discontinuation, which is significantly higher (around 32%) in surgical patients. Resolution vs. Improvement: Resolution: Often defined as achieving a BP <140/90 mmHg (or <130/80 mmHg per some AHA guidelines) while being off all medications. Improvement: Defined as a ≥30% reduction in antihypertensive medications while maintaining controlled BP.	6 months, 1,2,3,4 and 5 years postoperatively
Comorbidity resolution	OSA (obstructive sleep apnea) The most reliable way to compare status is through a follow-up polysomnography or home sleep test. Apnea-Hypopnea Index (AHI): This is the primary metric. It measures the number of pauses in breathing per hour of sleep. Cure/Resolution: Defined as an AHI < 5. Improvement: Often defined as an AHI reduction of at least 50% or reaching a threshold of AHI < 15. Oxygen Desaturation Index (ODI): Measures the number of times blood oxygen levels drop significantly per hour. Bariatric surgery typically leads to a marked decrease in this index. Mean and Nadir SpO2: Comparison of average and lowest oxygen saturation levels during sleep, which generally increase after surgery. Treatment Requirements CPAP Pressure: For patients who still require treatment, the required therapeutic pressure (measured in cmH2O or mbar) typically decreases post-operatively. Discontinuation Rate: A common comparison point is the percentage of patients who can stop using CPAP entirely.	6 months, 1,2,3,4 and 5 years postoperatively
Quality of Life (SF-36)	Quality of Life (QoL) scores typically show dramatic initial improvements, particularly in physical domains, followed by a stabilization or gradual decline over the long term. The Short Form-36 (SF-36) questionnaire measures eight health domains on a scale of 0 (lowest) to 100 (highest): Physical Component Summary (PCS): Includes Physical Functioning (PF), Role-Physical (RP), Bodily Pain (BP), and General Health (GH). Mental Component Summary (MCS): Includes Vitality (VT), Social Functioning (SF), Role-Emotional (RE), and Mental Health (MH). Typical Score Trends Pre-Surgery (Baseline): Patients often start with global QoL scores around 45.6 to 48.3. Physical component scores are typically significantly lower than population norms. 1 Year Post-Surgery: Global scores often peak, reaching approximately 79.7. Both PCS and MCS frequently return to or exceed general population norms (typically around 50 for summary scores) during this period.	1, 2, 3, 4, and 5 years postoperatively
Food tolerance (FTQ)	Food tolerance is a key measure of success after bariatric surgery, often assessed using the Food Tolerance Quality (FTQ), also known as the Suter Score or "Quality of Alimentation" questionnaire. This standardized tool quantifies how well you can ingest and digest various foods without symptoms like nausea, vomiting, or pain. The FTQ evaluates three main areas to produce a score between 1 and 27: Satisfaction: Your overall perception of your eating quality (from "excellent" to "very bad"). Food Variety: Your ability to eat 8 specific food groups (red meat, white meat, fish, vegetables, salad, rice, pasta, and bread) without difficulty. Vomiting/Regurgitation: The frequency of these symptoms (scored 0-6). Scoring Breakdown: ≥24: Good food tolerance. 20-24: Moderate food tolerance. <20: Poor food tolerance.	6 months, 3 and 5 years postoperatively.
Comorbidity resolution	Dyslipidemia Comparing pre-operative to post-operative lipid profiles involves monitoring specific biochemical markers and clinical milestones at standardized intervals. 1. Key Biochemical Markers Clinicians track four primary components to measure improvement or resolution: Triglycerides (TG): Usually show the most rapid and significant drop post-surgery. HDL ("Good") Cholesterol: Typically starts low pre-operatively and increases significantly over 12-15 months. LDL ("Bad") Cholesterol: Often decreases, though the extent of change can vary depending on the surgical procedure. TC/HDL Ratio: This ratio is a key indicator of cardiovascular risk reduction. Clinical Definition of Resolution A patient is often considered to have "resolved" dyslipidemia if they meet these post-operative criteria without the use of lipid-lowering medications: LDL: <160 mg/dL (or specific target based on risk). Triglycerides: <200 mg/dL. HDL: >40 mg/dL (men) or >50 mg/dL (women).	6 months, 1,2,3,4 and 5 years postoperatively
Reoperation rates	The reoperation rates done in a number of patients between the 2 groups.	1, 2, 3, 4, and 5 years postoperatively
Operative data	operative time between the 2 groups (RYGB vs. B-RYGB)	Intraoperative
Metabolic/hormonal panel	Clinical Significance Appetite Suppression: Elevated PYY promotes an early sense of satiety and reduced meal size, contributing to sustained weight loss. Diabetes Remission: PYY is a key humoral factor in the early recovery of impaired insulin and glucagon secretion after surgery, often independent of weight loss. Predicting Outcomes: The ability of PYY to increase early after surgery (measured 6 months post-op) is a strong predictor of long-term weight maintenance at 3 years. Common PYY Measurement Values Healthy circulating levels vary based on fasting state and sex: Fasting Levels: Typically range from 10 to 17 pmol/L in lean individuals. In mass units, average fasting levels are often around 100-120 pg/mL. Postprandial (After Meal) Peak: Levels usually rise within 1 hour of eating, typically reaching 23-45 pg/mL or higher depending on meal size and caloric density.	6months, 1,2,3 and 5 years postoperatively
Metabolic/hormonal panel	Measuring endogenous GLP-1 is challenging because it has a very short half-life of roughly 1-2 minutes before being degraded by enzymes. Fasting Levels: Typically range from 0 to 15 pmol/L. Post-Meal Levels: Can increase 2- to 3-fold following food consumption. Measurement Methods: Laboratory tests primarily use ELISA (Enzyme-Linked Immunosorbent Assay) to detect either "active" GLP-1 or "total" GLP-1. One of the primary reasons bariatric surgery is so effective for weight loss and type 2 diabetes remission is the dramatic natural increase in GLP-1 production after surgery. Postprandial (After-Meal) Levels: Following procedures like Roux-en-Y gastric bypass (RYGB), post-meal GLP-1 levels can increase by as much as 10-fold compared to pre-surgery levels. This happens because food reaches the distal part of the small intestine much faster than before. Weight Loss Marker: Higher post-surgical GLP-1 responses are often associated with more robust and sustained weight loss.	6months, 1,2,3 and 5 years postoperatively
Metabolic/hormonal panel	GIP (Gastric Inhibitory Polypeptide or Glucose-dependent Insulinotropic Polypeptide) measurements involve determining blood levels of this hormone, primarily for researching metabolism, obesity, and diabetes. Total GIP (active 1-42 + inactive 3-42) is measured using ELISA kits. RYGB typically leads to a decrease in GIP levels, particularly in response to food (postprandial). Mechanism: The "Foregut Hypothesis" suggests that bypassing the duodenum and proximal jejunum-where GIP-producing K-cells are most concentrated-prevents nutrients from stimulating these cells. Fasting Levels: Many studies show a significant decrease in fasting GIP levels within 1 to 6 months post-surgery. Postprandial Levels: Research consistently finds lower post-meal GIP concentrations compared to pre-operative levels. Clinical Impact: Lower GIP is associated with reduced fat accumulation and improved insulin sensitivity, contributing to the resolution of Type 2 Diabetes.	6months, 1,2,3 and 5 years postoperatively
Metabolic/hormonal panel	Leptin Bariatric surgery leads to significant decreases in fasting leptin levels, often reported as a decline from pre-operative obesity levels. Leptin is typically measured through blood tests using the following laboratory techniques: ELISA (Enzyme-Linked Immunosorbent Assay): The most common method used in clinical research to quantify serum or plasma leptin concentrations. Normal Ranges (Reference): Females: 0.5 to 15.2 ng/mL. Males: 0.5 to 12.5 ng/mL.	1,3 and 5 years postoperatively
Metabolic/hormonal panel	Ghrelin Measurement results are more heterogeneous. While some studies show a significant decrease in the first few months, others report that levels may return to or even exceed baseline at one year. Researchers and clinicians use several specialized techniques to measure ghrelin in bariatric patients: Assay Types: ELISA (Enzyme-Linked Immunosorbent Assay): The most common method for measuring total or acylated ghrelin in blood plasma or serum. Before surgery, ghrelin levels in obese individuals are typically lower than in lean individuals. Obese Baseline: Often ranges between 300-600 pg/mL for total ghrelin. Lean Reference: Generally higher, often exceeding 800 pg/mL.	1,3 and 5 years postoperatively
Safety outcomes: Bleeding	General perioperative complications: Bleeding: Major postoperative bleeding (mPOB) in bariatric patients is generally defined by the following metrics: Hemoglobin Drop: A decrease in hemoglobin levels of more than 2 g/dL, often within 48 hours. Clinical Intervention: A requirement for transfusion (e.g., more than or equal 2 units of red blood cells), therapeutic endoscopy, or surgical re-intervention. Clinical Symptoms: Tachycardia (more than 120 bpm), hypotension (less than 90 over 60 mmHg), dizzy spells, or the presence of bloody drainage.	perioperative until 1 month postoperatively
Safety outcomes: Anastomotic leak	General perioperative complications: Anastomotic leak: CT Scan with Oral/IV Contrast: Considered the most reliable imaging modality, though CT can sometimes fail to show minor leaks.	perioperative until 1 month postoperatively
Safety outcomes: Infection	General perioperative complications: Infection: Measurement and Diagnostic Metrics C-Reactive Protein (CRP): A key, non-specific blood marker used to predict postoperative infections. Studies indicate that high CRP levels on post-operative days (PODs) 3 and 5 are indicative of infectious complications, particularly in differentiating between simple, low-risk cases and those with severe infection. White Blood Cell Count (WBC): Frequently monitored alongside CRP for signs of systemic inflammation.	perioperative until 1 month postoperatively
Safety outcomes: DVT/PE	General perioperative complications: Deep vein thrombosis/Pulmonary embolism Measurement and Diagnostic Methods: Imaging (Gold Standard): Spiral CT angiography (PE protocol) is the definitive diagnostic method for pulmonary embolism. Venous Ultrasound: Used to detect lower extremity DVT, which can be suspected if there is >3 cm difference in circumference between legs, or symptomatic swelling. Laboratory Tests: D-dimer tests are used to detect fibrin degradation, helping to rule out thrombosis.	perioperative until 1 month postoperatively
Safety outcomes: Ring-related complications	Ring-related complications: Early: leak, hemorrhage, melena, vomiting, internal or port-site hernia. Late: slippage, erosion, stenosis, chronic vomiting, persistent food intolerance.	At 1, 3, 4, and 5 years, or earlier if symptomatic (dysphagia, vomiting, suspected stricture, ulcer, or band-related complication).

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): March 15, 2026
• Primary Completion (Estimated): March 1, 2031
• Study Completion (Estimated): March 1, 2031

Study Registration Dates

• First Submitted: February 14, 2026
• First Submitted That Met QC Criteria: February 20, 2026
• First Posted (Actual): February 27, 2026

Study Record Updates

• Last Update Posted (Actual): April 29, 2026
• Last Update Submitted That Met QC Criteria: April 24, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: Quality of Life; Weight Loss; Gastric Bypass; Revisional Laparoscopic Roux-en-Y; Ringed Revisional Roux-en-Y; BAROS Score; Food Tolerance
• Additional Relevant MeSH Terms: Body Weight; Body Weight Changes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Weight Loss
• Other Study ID Numbers: Revisional ringed roux vs roux

Plan for Individual participant data (IPD)

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

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No