Semaglutide Before Primary Metabolic and Bariatric Surgery in Patients With BMI 60 kg/m² or Higher

Semaglutide escalated to 2.4 mg weekly over 16 weeks before surgery, held 7 days before operation.

Weeks 0 to 16: semaglutide 0.25, 0.5, 1.0, 1.7, then 2.4 mg weekly in 4-weekly steps, or matched placebo. Slower escalation allowed for tolerance; minimum acceptable plateau 1.7 mg.

Last injection at least 7 days before surgery. Clear fluids for 24 hours before induction. Anesthesia manages every trial patient with full-stomach precautions.

Surgery in weeks 17 to 18: laparoscopic SG or RYGB by the standardized unit technique, chosen and declared before randomization. Every operation recorded in full.

Matched placebo pens on the identical schedule

Matched placebo pens on the identical schedule

Each anonymized video is rated independently by three blinded expert bariatric surgeons on five domains (liver size and handling; exposure; tissue fragility and adhesions; bleeding tendency; overall difficulty), each 1 to 5, total 5 to 25. The mean of the three raters is the patient's score. Raters are trained on a calibration set of 10 non-trial videos before unblinded rating begins; inter-rater reliability (ICC) is reported.

Total weight loss measured in Kilograms

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

Bleeding intraoperative measured in milliliters

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.

Number of cases converted from laparoscopic to open surgery.

Number of stapler loads in each case.

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.

By standardized ultrasound A normal adult liver span measured by ultrasound along the midclavicular line is typically less than 15 to 16 cm in the craniocaudal (vertical) dimension.

Right Lobe (Craniocaudal): Usually 13 to 15 cm; values above 15-16 cm often suggest hepatomegaly (enlarged liver).

Left Lobe (Width/Thickness): Usually less than 7 cm.

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.

Waist circumference is a direct measurement of belly fat that helps assess your risk for chronic health issues like heart disease and type 2 diabetes.

Health risk increases when waist size goes past certain thresholds:

• Men: High risk starts above 102 cm (40 inches) according to standard guidelines, though some organizations flag risks starting at 94 cm (37 inches).
• Women: High risk starts above 88 cm (35 inches), with tighter thresholds starting at 80 cm (31.5 inches) in some regional guidelines.

Of semaglutide including gastrointestinal adverse events and any aspiration event at induction.