Prospective Evaluation of Stapled Intact-Duodenum Bipartition With Sleeve Gastrectomy (SIBS)

Korábbi kezelés

• Contraindication to general anesthesia or laparoscopic metabolic/bariatric surgery.
• Previous gastrointestinal surgery resulting in anatomy that precludes safe performance of the planned SIBS procedure, except previous sleeve gastrectomy in participants undergoing an eligible revisional procedure.
• Pre-existing severe protein-calorie malnutrition or clinically significant nutritional deficiency that cannot be adequately corrected before surgery.

Más betegség

• Active inflammatory bowel disease involving the small intestine.
• Active gastrointestinal malignancy or other active malignancy for which the proposed operation or follow-up would be inappropriate.
• Severe hepatic dysfunction, severe renal dysfunction, or another major systemic illness considered to confer an unacceptable operative or nutritional risk.
• Active gastrointestinal ulceration or another gastrointestinal condition considered to substantially increase the risk of the planned procedure.
• Uncontrolled psychiatric illness or cognitive impairment that precludes valid informed consent or adherence to postoperative care.
• Active alcohol or substance use disorder considered incompatible with safe metabolic and bariatric surgery.
• Any medical, surgical, anatomical, or psychosocial condition that, in the judgment of the multidisciplinary bariatric team, makes participation or performance of SIBS inappropriate or unsafe.

Életkor

• Age \<18 years or \>65 years.

Egyéb

• Pregnancy or breastfeeding.
• Planned pregnancy during the 12-month postoperative study period.
• Intraoperative anatomy that prevents safe creation of a tension-free side-to-side duodenoileal anastomosis.
• Inability or unwillingness to adhere to postoperative dietary recommendations, nutritional supplementation, or scheduled follow-up.

• Age 18-65 years.
• Body mass index (BMI) ≥35 kg/m², regardless of the presence or severity of obesity-associated medical conditions; or BMI 30.0-34.9 kg/m² with type 2 diabetes mellitus or another clinically significant obesity-associated medical condition and inadequate weight loss or improvement following appropriate nonsurgical management.
• Eligible for metabolic and bariatric surgery following multidisciplinary clinical assessment.
• Considered suitable for laparoscopic Stapled Intact-Duodenum Bipartition with Sleeve Gastrectomy (SIBS) based on preoperative assessment.
• For primary procedures, no previous metabolic or bariatric surgical procedure.
• For revisional procedures, previous sleeve gastrectomy with a clinical indication for revisional metabolic/bariatric surgery and anatomy considered suitable for SIBS.
• Able to understand the investigational nature of the SIBS procedure, its potential risks and benefits, and established alternative bariatric procedures.
• Able and willing to provide written informed consent.
• Willing and able to comply with the scheduled postoperative clinical, nutritional, laboratory, and study follow-up for at least 12 months.