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

NCT07765758 | Not Yet Recruiting

• 1 other identifier: MCMSS-MREC 80/2026
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

Obesity is a chronic disease that can be treated with metabolic and bariatric surgery when appropriate. This study will prospectively evaluate a new laparoscopic bariatric procedure called Stapled Intact-Duodenum Bipartition with Sleeve Gastrectomy (SIBS). SIBS combines sleeve gastrectomy with a side-to-side connection between the first part of the duodenum and the ileum. Unlike standard single-anastomosis duodenoileal bypass with sleeve gastrectomy (SADI-S), the duodenum is not divided. Instead, the new connection is created while the duodenum remains intact, allowing food to continue through the normal duodenal pathway while also providing an additional pathway to the ileum. The connection is created laparoscopically using a conventional linear surgical stapler. The main purpose of this prospective study is to evaluate the technical feasibility and short-term safety of the SIBS procedure in adults undergoing metabolic and bariatric surgery. The study will assess whether the planned procedure can be completed successfully and will record postoperative complications occurring within 30 days after surgery. Participants will also be followed after surgery to evaluate weight loss, changes in body mass index, glycemic control and other obesity-associated medical conditions, nutritional status, gastrointestinal symptoms, hospital readmission, reoperation, and procedure-related complications. Follow-up assessments are planned for up to 12 months after surgery. The study is intended to provide prospective evidence regarding the safety, feasibility, and early clinical outcomes of this surgical approach. Longer-term and comparative studies will be needed to determine how its outcomes compare with established metabolic and bariatric procedures

Conditions

Obesity; Obesity Type 2 Diabetes Mellitus

Keywords

Metabolic and Bariatric Surgery; Duodenoileal Bipartition; Duodenal Bipartition; Stapled Intact-Duodenum Bipartition with Sleeve Gastrectomy; SIBS; Sleeve Gastrectomy; Side-to-Side Duodenoileal Anastomosis; Metabolic Surgery; Linear Stapler

Outcome Measures

Primary Outcomes (2)

• Proportion of Participants With Successful Technical Completion of the SIBS Procedure

  Technical success is defined as successful laparoscopic completion of the planned Stapled Intact-Duodenum Bipartition with Sleeve Gastrectomy (SIBS), including creation of the side-to-side duodenoileal anastomosis with preservation of an intact, non-transected duodenum, without conversion to open surgery or conversion to an alternative bariatric procedure. The outcome will be reported as the number and percentage of participants who meet all criteria for technical success.

  During the index surgical procedure

• Proportion of Participants With Major Postoperative Complications Within 30 Days

  Major postoperative morbidity will be defined as the occurrence of one or more complications classified as Clavien-Dindo grade III or higher within 30 days after surgery. This includes complications requiring surgical, endoscopic, or radiological intervention; life-threatening complications requiring intensive care management; and death. Events of particular interest include anastomotic leak, intra-abdominal collection, gastrointestinal bleeding, bowel obstruction, unplanned reoperation, and unplanned endoscopic or radiological intervention. Results will be reported as the number and percentage of participants experiencing at least one major complication.

  From the day of surgery through postoperative day 30

Secondary Outcomes (14)

• Percentage Total Weight Loss (%TWL) at 12 Months

  12 months after surgery

• Percentage Excess Weight Loss (%EWL) at 12 Months

  12 months after surgery

• Change in Body Mass Index From Baseline to 12 Months

  Baseline to 12 months after surgery

• Change in Glycated Hemoglobin (HbA1c) From Baseline to 12 Months

  Baseline to 12 months after surgery

• Proportion of Participants With Type 2 Diabetes Remission at 12 Months

  12 months after surgery

Other Outcomes (1)

• Proportion of Participants With Contrast Passage Through Both Gastrointestinal Pathways

  At protocol-specified postoperative contrast imaging, within 3 months after surgery

Study Arms (1)

Stapled Intact-Duodenum Bipartition With Sleeve Gastrectomy (SIBS)

EXPERIMENTAL

Participants assigned to this single study arm will undergo laparoscopic Stapled Intact-Duodenum Bipartition with Sleeve Gastrectomy (SIBS). The procedure consists of sleeve gastrectomy followed by creation of a side-to-side duodenoileal anastomosis between the intact first portion of the duodenum and an ileal loop using a conventional laparoscopic linear stapler. The duodenum is not transected, preserving continuity of the native pyloro-duodenojejunal pathway while creating an additional duodenoileal pathway. Participants will undergo standardized postoperative follow-up to assess technical feasibility, perioperative safety, weight-loss outcomes, metabolic outcomes, nutritional status, and procedure-related complications

Procedure: Stapled Intact-Duodenum Bipartition With Sleeve Gastrectomy (SIBS)

Interventions

Stapled Intact-Duodenum Bipartition With Sleeve Gastrectomy (SIBS) PROCEDURE

SIBS is a laparoscopic metabolic and bariatric procedure combining sleeve gastrectomy with a side-to-side duodenoileal anastomosis without duodenal transection. Following sleeve gastrectomy, an ileal loop at a protocol-defined distance from the ileocecal valve is brought ante-colically to the first portion of the duodenum. Small enterotomies are created in the duodenum and ileum, and a conventional laparoscopic linear stapler is used to construct the side-to-side anastomosis. The common enterotomy is closed laparoscopically. The duodenum remains intact, preserving the native pyloro-duodenojejunal pathway while creating an additional duodenoileal pathway. Anastomotic integrity is assessed intraoperatively before completion of the procedure.

Stapled Intact-Duodenum Bipartition With Sleeve Gastrectomy (SIBS)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Age \<18 years or \>65 years.
• Pregnancy or breastfeeding.
• Planned pregnancy during the 12-month postoperative study period.
• 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.
• Intraoperative anatomy that prevents safe creation of a tension-free side-to-side duodenoileal anastomosis.
• 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.
• Pre-existing severe protein-calorie malnutrition or clinically significant nutritional deficiency that cannot be adequately corrected before surgery.
• 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.
• Inability or unwillingness to adhere to postoperative dietary recommendations, nutritional supplementation, or scheduled follow-up.
• 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.

Sponsors & Collaborators

• Medical City for Military and Security Services: lead

Study Sites (1)

Division of Bariatric and Metabolic Surgery, Medical City for Military and Security Services

Muscat, 111, Oman

Location

Related Publications (4)

• Cadiere GB, Poras M, Marechal MT, Pau L, Muteganya R, Gossum MV, Cadiere B, Sante NV, Gagner M. Sleeve gastrectomy with duodenoileal bipartition using linear magnets: feasibility and safety at 1-year follow-up. J Gastrointest Surg. 2024 May;28(5):640-650. doi: 10.1016/j.gassur.2024.02.001. Epub 2024 Feb 9.

  PMID: 38704201 BACKGROUND

• Gagner M, Abuladze D, Koiava L, Buchwald JN, Van Sante N, Krinke T. First-in-Human Side-to-Side Magnetic Compression Duodeno-ileostomy with the Magnet Anastomosis System. Obes Surg. 2023 Aug;33(8):2282-2292. doi: 10.1007/s11695-023-06708-x. Epub 2023 Jul 2.

  PMID: 37393568 BACKGROUND

• Brown WA, de Leon Ballesteros GP, Ooi G, Higa K, Himpens J, Torres A, Shikora S, Kow L, Herrera MF; IFSO appointed task force reviewing the literature on SADI-S/OADS. Single Anastomosis Duodenal-Ileal Bypass with Sleeve Gastrectomy/One Anastomosis Duodenal Switch (SADI-S/OADS) IFSO Position Statement-Update 2020. Obes Surg. 2021 Jan;31(1):3-25. doi: 10.1007/s11695-020-05134-7. Epub 2021 Jan 6.

  PMID: 33409979 BACKGROUND

• Sanchez-Pernaute A, Rubio Herrera MA, Perez-Aguirre E, Garcia Perez JC, Cabrerizo L, Diez Valladares L, Fernandez C, Talavera P, Torres A. Proximal duodenal-ileal end-to-side bypass with sleeve gastrectomy: proposed technique. Obes Surg. 2007 Dec;17(12):1614-8. doi: 10.1007/s11695-007-9287-8. Epub 2007 Nov 27.

  PMID: 18040751 BACKGROUND

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Mohammed Al Sibani, MD, FRCSC

  Medical City for Military and Security Services

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mohammed Al Sibani, MD, FRCSC

CONTACT

0096899360515; med1500@yahoo.com

Younis Al-Mufargi, MD

CONTACT

0096895622838; hashyounis96@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Consultant General, MIS, and Bariatric Surgeon

Study Record Dates

• First Submitted: August 11, 2026
• First Posted: August 14, 2026
• Study Start: August 1, 2026
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: August 14, 2026

Record last verified: 2026-08

Locations

OM (1)