Semaglutide Given Before and After Conversion of Sleeve Gastrectomy to Roux-en-Y Gastric Bypass for Recurrent Weight Gain

Semaglutide 2.4 mg weekly: 16 weeks before conversion, held 7 days before surgery, restarted 4 weeks after surgery, continued to 12 months after surgery.

Weekly subcutaneous injections from identical, pharmacy-labelled pens. The active arm receives semaglutide 2.4 mg. Escalation: 0.25, 0.5, 1.0, 1.7, 2.4 mg at 4-week steps. If 2.4 mg is not tolerated, the patient stays on the highest tolerated dose of at least 1.0 mg. Patients who cannot tolerate 1.0 mg stop injections but stay in the trial and are analyzed in their arm.

Matched placebo on the identical schedule.

Weekly subcutaneous injections from identical, pharmacy-labelled pens. The placebo arm receives matched placebo. Escalation: 0.25, 0.5, 1.0, 1.7, 2.4 mg at 4-week steps. If 2.4 mg is not tolerated, the patient stays on the highest tolerated dose of at least 1.0 mg. Patients who cannot tolerate 1.0 mg stop injections but stay in the trial and are analyzed in their arm.

Measured in kilograms at month 18 after randomization. Baseline is the randomization weight.

Equation: BMI = weight (In kilograms) / [height (In meters)]^2

An HbA1c level reflects your average blood sugar over the past two to three months, and any meaningful change typically takes at least 6 weeks to show because red blood cells live for about 3 months.

Normal: Below 5.7% Prediabetes: 5.7% to 6.4% Diabetes: 6.5% or higher

Normal blood pressure is less than 120 mm Hg systolic and less than 80 mm Hg diastolic.

Systolic (Top Number): Measures the pressure in your arteries when your heart beats and contracts.

Diastolic (Bottom Number): Measures the pressure in your arteries when your heart rests between beats.

Normal: Less than 120 mm Hg systolic and less than 80 mm Hg diastolic. Elevated: 120-129 mm Hg systolic and less than 80 mm Hg diastolic. Stage 1 Hypertension (High Blood Pressure): 130-139 mm Hg systolic or 80-89 mm Hg diastolic.

Stage 2 Hypertension: 140 mm Hg or higher systolic, or 90 mm Hg or higher diastolic.

Hypertensive Crisis: Higher than 180 mm Hg systolic and/or higher than 120 mm Hg diastolic. This requires immediate emergency medical care

Normal adult values for a lipid panel are measured in milligrams per deciliter (mg/dL):

Total Cholesterol: Below 200 mg/dL is desirable. (Borderline high is 200-239 mg/dL, and high is 240 mg/dL and above.) LDL ("Bad") Cholesterol: Below 100 mg/dL is optimal. (130-159 mg/dL is borderline high, and 160-189 mg/dL or higher is high.) HDL ("Good") Cholesterol: 60 mg/dL and higher is protective. Levels below 40 mg/dL for men or below 50 mg/dL for women are considered low.

Triglycerides: Below 150 mg/dL is normal. (Borderline high is 150-199 mg/dL, and high is 200-499 mg/dL.)

From the start till the end of the surgery measured in minutes

Adverse intraoperative events (AIEs) occur in approximately 3% to 7% of bariatric surgeries and increase the relative risk of overall postoperative complications by about 90%.

Organ Injuries: Unintentional lacerations or punctures to the liver, spleen, stomach, intestines, or major blood vessels during trocar placement or dissection.

Intraoperative Bleeding: Significant hemorrhage from staple lines, mesentery, or the abdominal wall requiring intervention or transfusion.

Anastomosis and Staple Line Issues: Leaks, bleeding, or technical difficulties during the creation of pouches or connections (such as in a Roux-en-Y Gastric Bypass), identified via intraoperative leak tests.

Equipment Malfunction: Failures involving laparoscopic staplers, cameras, insufflation systems, or energy devices.

Anesthesia-Related Events: Severe hemodynamic instability, difficult airway management, or allergic reactions linked to medications.

The Clavien-Dindo Classification grades 30-day postoperative complications based on the level of medical or surgical therapy needed to treat them.

Grade I: Any deviation from the normal postoperative course without the need for pharmacological treatment or surgical, endoscopic, and radiological interventions.

Grade II: Requiring pharmacological treatment with drugs other than those allowed for Grade I, including blood transfusions and total parenteral nutrition.

Grade III: Requiring surgical, endoscopic, or radiological intervention. Grade IIIa: Intervention not under general anesthesia. Grade IIIb: Intervention under general anesthesia. Grade IV: Life-threatening complication (including central nervous system complications) requiring intermediate care or intensive care unit (ICU) management.

Grade V: Death of a patient.

A change in the GerdQ score reflects how gastroesophageal reflux disease (GERD) symptoms and their daily impact respond to treatment or evolve over time.

Range: The total score spans from 0 to 18. Diagnosis Threshold: A score of 8 or higher indicates a high likelihood of GERD.

Components: It evaluates four positive predictors (heartburn, regurgitation, sleep disturbance, and over-the-counter medication use) and two negative predictors (epigastric pain and nausea) over the past 7 days.

Decrease in Score: A lowering score (especially moving from ≥ 8 to < 8) typically indicates successful treatment response, reduced symptom frequency, and lower disease impact.

Increase or No Change: A rising score or a score that remains persistently above 8 suggests ongoing treatment failure, unmanaged symptom triggers, or disease progression.

The IWQOL-Lite-CT (Impact of Weight on Quality of Life-Lite Clinical Trials Version) score ranges from 0 to 100, where 100 represents the best possible quality of life and functioning (meaning zero weight-related impairment).

Total Score Range: 0-100 (higher = better quality of life) Domain/Composite Scores: 0-100 Raw scores are converted or transformed to a 0-100 scale for standard reporting.

(bioelectrical impedance analysis, standardized hydration instructions), with fat-free mass loss reported as a proportion of total weight change and hand-grip strength measured at weeks 0, 32, and 68, so that mass is interpreted together with function per the ESPEN/EASO sarcopenic-obesity framework and current meta-analytic evidence.

A hand grip strength test measures the maximum force of your hand and forearm muscles using a portable device called a handgrip dynamometer.

Position yourself: Sit up straight with your feet flat on the floor. Place your arm by your side with your elbow bent at a 90-degree angle and your wrist in a neutral position.

Hold the device: Adjust the handle so it fits comfortably in your hand. Squeeze hard: Squeeze the handles as hard as you can for about 3 to 5 seconds without moving your arm or resting the device against your body.

Repeat trials: Take three measurements for each hand, resting for 15 to 30 seconds between attempts. Use either the highest score or the average of the trials.

A normal hand grip strength score typically ranges from 40 to 56 kg (88 to 123 lbs) for adult men and 25 to 36 kg (55 to 79 lbs) for adult women aged 20-29.

all adverse events, with events of special interest: pancreatitis, gallstones, severe gastrointestinal intolerance, hypoglycemia, dumping, aspiration at induction, venous thromboembolism, mortality.