Revisional Bariatric Surgery
Conditions
Keywords
Gastric Bypass, Revisional Laparoscopic Roux-en-Y, Ringed Revisional Roux-en-Y, Weight Loss, BAROS Score, Quality of Life, Food Tolerance
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.
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.
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.
Sponsors
General Committee of Teaching Hospitals and Institutes, Egypt
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Comorbidity resolution | 6 months, 1,2,3,4 and 5 years postoperatively | 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. |
| Quality of Life (SF-36) | 1, 2, 3, 4, and 5 years postoperatively | 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. |
| Food tolerance (FTQ) | 6 months, 3 and 5 years postoperatively. | 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. |
| Safety outcomes: Bleeding | perioperative until 1 month postoperatively | 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. |
| Safety outcomes: Anastomotic leak | perioperative until 1 month postoperatively | 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. |
| Safety outcomes: Infection | perioperative until 1 month postoperatively | 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. |
| Safety outcomes: DVT/PE | perioperative until 1 month postoperatively | 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. |
| Safety outcomes: Ring-related complications | At 1, 3, 4, and 5 years, or earlier if symptomatic (dysphagia, vomiting, suspected stricture, ulcer, or band-related complication). | Ring-related complications: Early: leak, hemorrhage, melena, vomiting, internal or port-site hernia. Late: slippage, erosion, stenosis, chronic vomiting, persistent food intolerance. |
| Reoperation rates | 1, 2, 3, 4, and 5 years postoperatively | The reoperation rates done in a number of patients between the 2 groups. |
| Operative data | Intraoperative | operative time between the 2 groups (RYGB vs. B-RYGB) |
| Metabolic/hormonal panel | 6months, 1,2,3 and 5 years postoperatively | 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. |
Countries
Egypt
Contacts
CONTACTMohamed H Ashour, PhD
Outcome results
None listed