ObesitySIBSNCT07765758
Prospective Evaluation of Stapled Intact-Duodenum Bipartition With Sleeve Gastrectomy (SIBS)
A study testing Stapled Intact-Duodenum Bipartition With Sleeve Gastrectomy (SIBS) in people with Obesity and Obesity Type 2 Diabetes Mellitus, run by Medical City for Military and Security Services at 1 site in Oman.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Obesity, Obesity Type 2 Diabetes Mellitus
- What is being tested?
- Stapled Intact-Duodenum Bipartition With Sleeve Gastrectomy (SIBS)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteOman
- Study dates
- 1 Aug 2026to 31 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Oman1 site
Division of Bariatric and Metabolic Surgery, Medical City for Military and Security Services
Muscat, 111
Mohammed Al Sibani, MD, FRCSC, +96899360515, med1500@yahoo.com
Mohammed Al Sibani, MD, FRCSC
About this study
Official title: Safety, Feasibility, and Clinical Outcomes of Laparoscopic Side-to-Side Duodenoileal Bipartition Without Duodenal Transection Using a Conventional Linear Stapler: A Prospective Interventional Study
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.
Read more
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
Read the detailed description
This is a prospective, single-arm, open-label interventional study evaluating Stapled Intact-Duodenum Bipartition with Sleeve Gastrectomy (SIBS) in adults undergoing metabolic and bariatric surgery.
Standard single-anastomosis duodenoileal bypass with sleeve gastrectomy (SADI-S) combines sleeve gastrectomy with transection of the proximal duodenum and creation of a duodenoileal anastomosis. SIBS modifies this anatomical configuration by preserving continuity of the duodenum and creating a side-to-side duodenoileal anastomosis without duodenal transection. The rationale for this approach is to establish a duodenoileal pathway while avoiding creation of a blind-ending duodenal stump and maintaining continuity of the native proximal intestinal pathway. Whether these anatomical differences translate into clinically meaningful differences in safety, weight loss, metabolic outcomes, nutritional outcomes, or gastrointestinal function requires prospective evaluation.
The procedure is performed laparoscopically. Sleeve gastrectomy is performed using standard bariatric surgical principles. An ileal loop is then identified at a protocol-defined distance proximal to the ileocecal valve and brought ante-colically to the first portion of the duodenum in an isoperistaltic orientation. Small enterotomies are created in the duodenum and ileum, and a conventional laparoscopic linear stapler is used to construct a side-to-side duodenoileal anastomosis. The common enterotomy is closed laparoscopically. The duodenum is not transected, thereby maintaining continuity of the native pyloro-duodenojejunal pathway in addition to the newly created duodenoileal pathway. Anastomotic integrity is assessed intraoperatively before completion of the procedure.
The primary objectives of the study are to assess technical feasibility and short-term safety. Technical feasibility will be evaluated by successful laparoscopic completion of the planned SIBS procedure with creation of the side-to-side duodenoileal anastomosis while preserving an intact duodenum and without conversion to an alternative bariatric procedure or open surgery. Short-term safety will be evaluated by prospectively recording major postoperative complications occurring within 30 days after surgery.
Perioperative outcomes will include operative time, estimated blood loss, conversion, length of hospital stay, postoperative complications, unplanned intervention, readmission, reoperation, and mortality. Particular attention will be given to complications potentially related to the duodenoileal anastomosis, including anastomotic leak, bleeding, obstruction, stenosis, ulceration, intra-abdominal collection, and other gastrointestinal complications.
Participants will undergo standardized postoperative clinical and laboratory follow-up for up to 12 months. Weight-related outcomes will include body weight, body mass index (BMI), percentage total weight loss (%TWL), and percentage excess weight loss (%EWL) at predefined postoperative time points. Metabolic assessment will include glycemic measures such as glycated hemoglobin (HbA1c) and changes in treatment requirements among participants with type 2 diabetes mellitus or prediabetes. Changes in other obesity-associated medical conditions, including hypertension and dyslipidemia, will also be documented where applicable.
Nutritional follow-up will include clinically appropriate laboratory assessment of hematological, protein, mineral, and micronutrient parameters according to the institutional metabolic and bariatric surgery follow-up protocol. Gastrointestinal symptoms and clinically relevant postoperative events will be prospectively recorded throughout follow-up.
Where specified in the final study protocol, postoperative imaging may be used to assess anastomotic patency and passage of contrast through the native duodenojejunal and duodenoileal pathways. Any imaging or metabolic investigations performed specifically for research purposes will be predefined in the approved study protocol.
The study is designed as an initial prospective evaluation of the feasibility, safety, and clinical outcomes of SIBS. It is not designed to establish superiority or noninferiority to SADI-S, Roux-en-Y gastric bypass, sleeve gastrectomy, or other established bariatric procedures. Findings from this study are intended to inform subsequent larger and comparative studies evaluating the longer-term effectiveness, metabolic effects, nutritional consequences, and safety of the procedure.
- Conditions
- Obesity, Obesity Type 2 Diabetes Mellitus
- Being tested
- Stapled Intact-Duodenum Bipartition With Sleeve Gastrectomy (SIBS)
- 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
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stapled Intact-Duodenum Bipartition With Sleeve Gastrectomy (SIBS)Procedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Procedure: Stapled Intact-Duodenum Bipartition With Sleeve Gastrectomy (SIBS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: From the day of surgery through postoperative day 30
Secondary outcomes (14)
Percentage Total Weight Loss (%TWL) at 12 Months
Percentage total weight loss will be calculated as: %TWL = [(preoperative weight - postoperative weight) / preoperative weight] × 100. The mean %TWL and corresponding measures of variability will be reported for participants with available 12-month follow-up data.
Measured: 12 months after surgery
Percentage Excess Weight Loss (%EWL) at 12 Months
Percentage excess weight loss will be calculated as: %EWL = [(preoperative weight - postoperative weight) / (preoperative weight - ideal body weight)] × 100. Ideal body weight will be defined using the prespecified method in the study protocol. The mean %EWL and corresponding measures of variability will be reported.
Measured: 12 months after surgery
Change in Body Mass Index From Baseline to 12 Months
Body mass index (BMI) will be calculated as body weight in kilograms divided by height in meters squared (kg/m²). Change in BMI will be calculated as 12-month postoperative BMI minus preoperative BMI and reported as the mean change with corresponding measures of variability.
Measured: Baseline to 12 months after surgery
Change in Glycated Hemoglobin (HbA1c) From Baseline to 12 Months
Glycated hemoglobin (HbA1c) will be measured before surgery and at 12 months after surgery. Change in HbA1c will be calculated as the 12-month value minus the baseline value and reported in percentage points. Analyses will be performed for participants with available paired measurements, with additional assessment among participants with type 2 diabetes mellitus or prediabetes where appropriate.
Measured: Baseline to 12 months after surgery
Proportion of Participants With Type 2 Diabetes Remission at 12 Months
Among participants with type 2 diabetes mellitus at baseline, remission will be assessed at 12 months using prespecified consensus criteria. Remission will be defined as HbA1c <6.5% persisting for at least 3 months in the absence of glucose-lowering pharmacotherapy. The outcome will be reported as the number and percentage of participants with baseline type 2 diabetes who meet the remission criteria.
Measured: 12 months after surgery
Operative Time
Total operative time for the SIBS procedure will be recorded in minutes according to the prespecified operative start and completion points and summarized using appropriate measures of central tendency and variability.
Measured: During the index surgical procedure
Estimated Intraoperative Blood Loss
Estimated blood loss during the index surgical procedure will be recorded in milliliters and summarized using appropriate measures of central tendency and variability.
Measured: During the index surgical procedure
Postoperative Length of Hospital Stay
Postoperative hospital length of stay will be measured from the date of the index operation until hospital discharge and reported in days using appropriate measures of central tendency and variability.
Measured: From the day of surgery until hospital discharge, assessed up to 30 days
Proportion of Participants With Unplanned Hospital Readmission Within 30 Days
Any unplanned hospital readmission occurring within 30 days after the index SIBS procedure will be recorded. The outcome will be reported as the number and percentage of participants with at least one unplanned readmission.
Measured: From hospital discharge through postoperative day 30
Proportion of Participants Requiring Unplanned Reoperation Within 30 Days
Any unplanned surgical reoperation related to the index procedure occurring within 30 days after SIBS will be recorded. The indication and type of reoperation will also be documented. The outcome will be reported as the number and percentage of participants requiring at least one unplanned reoperation.
Measured: From the day of surgery through postoperative day 30
Proportion of Participants With Duodenoileal Anastomotic Leak Within 30 Days
Duodenoileal anastomotic leak will be defined as clinically, radiologically, endoscopically, or surgically confirmed leakage from the duodenoileal anastomosis. The outcome will be reported as the number and percentage of participants with a confirmed anastomotic leak within 30 days after surgery.
Measured: From the day of surgery through postoperative day 30
Proportion of Participants With Duodenoileal Anastomotic Stenosis
Duodenoileal anastomotic stenosis will be defined as symptomatic narrowing of the anastomosis confirmed by upper gastrointestinal imaging or endoscopy and/or requiring therapeutic intervention. The outcome will be reported as the number and percentage of participants with confirmed stenosis.
Measured: From surgery through 12 months after surgery
Proportion of Participants With Duodenoileal Anastomotic Ulceration
Clinically suspected anastomotic ulceration will be investigated according to standard clinical practice. Confirmed ulceration involving the duodenoileal anastomosis will be recorded when demonstrated endoscopically. The outcome will be reported as the number and percentage of participants with confirmed anastomotic ulceration.
Measured: From surgery through 12 months after surgery
Change in Selected Nutritional Laboratory Parameters From Baseline to 12 Months
Nutritional status will be assessed using prespecified laboratory parameters including hemoglobin, serum albumin, ferritin, vitamin B12, folate, calcium, and 25-hydroxyvitamin D. Values will be measured at baseline and 12 months after surgery. Absolute change from baseline will be calculated separately for each laboratory parameter and summarized using appropriate measures of central tendency and variability.
Measured: Baseline to 12 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2026
- Study start1 Aug 2026 (estimated)
- Primary completion1 Jan 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical City for Military and Security Services
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Mohammed Al Sibani, Medical City for Military and Security Services
- Investigators
- Mohammed Al Sibani, MD, FRCSC, Principal investigator, Medical City for Military and Security Services
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07765758
- Sponsor's protocol ID
- MCMSS-MREC 80/2026
- Acronym
- SIBS
- Status last verified
- Aug 2026
- First submitted
- 11 Aug 2026
- Last updated
- 14 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Individual participant data are not currently planned for public sharing because of participant confidentiality, the small study population, and institutional data-protection requirements. De-identified aggregate study results will be reported through peer-reviewed publications and scientific presentations in accordance with applicable ethical and institutional requirements.
Publications
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.
PubMed 38704201Gagner 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.
PubMed 37393568Brown 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.
PubMed 33409979Sanchez-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.
PubMed 18040751
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety, Feasibility, and Clinical Outcomes of Laparoscopic Side-to-Side Duodenoileal Bipartition Without Duodenal Transection Using a Conventional Linear Stapler: A Prospective Interventional Study
- ClinicalTrials.gov ID
- NCT07765758
- Acronym / sponsor ID
- SIBS / MCMSS-MREC 80/2026
- 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
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Medical City for Military and Security ServicesOther government
- Study start
- 1 Aug 2026 (estimated)
- Primary completion
- 1 Jan 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 14 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
This is a prospective, single-arm, open-label interventional study evaluating Stapled Intact-Duodenum Bipartition with Sleeve Gastrectomy (SIBS) in adults undergoing metabolic and bariatric surgery.
Standard single-anastomosis duodenoileal bypass with sleeve gastrectomy (SADI-S) combines sleeve gastrectomy with transection of the proximal duodenum and creation of a duodenoileal anastomosis. SIBS modifies this anatomical configuration by preserving continuity of the duodenum and creating a side-to-side duodenoileal anastomosis without duodenal transection. The rationale for this approach is to establish a duodenoileal pathway while avoiding creation of a blind-ending duodenal stump and maintaining continuity of the native proximal intestinal pathway. Whether these anatomical differences translate into clinically meaningful differences in safety, weight loss, metabolic outcomes, nutritional outcomes, or gastrointestinal function requires prospective evaluation.
The procedure is performed laparoscopically. Sleeve gastrectomy is performed using standard bariatric surgical principles. An ileal loop is then identified at a protocol-defined distance proximal to the ileocecal valve and brought ante-colically to the first portion of the duodenum in an isoperistaltic orientation. Small enterotomies are created in the duodenum and ileum, and a conventional laparoscopic linear stapler is used to construct a side-to-side duodenoileal anastomosis. The common enterotomy is closed laparoscopically. The duodenum is not transected, thereby maintaining continuity of the native pyloro-duodenojejunal pathway in addition to the newly created duodenoileal pathway. Anastomotic integrity is assessed intraoperatively before completion of the procedure.
The primary objectives of the study are to assess technical feasibility and short-term safety. Technical feasibility will be evaluated by successful laparoscopic completion of the planned SIBS procedure with creation of the side-to-side duodenoileal anastomosis while preserving an intact duodenum and without conversion to an alternative bariatric procedure or open surgery. Short-term safety will be evaluated by prospectively recording major postoperative complications occurring within 30 days after surgery.
Perioperative outcomes will include operative time, estimated blood loss, conversion, length of hospital stay, postoperative complications, unplanned intervention, readmission, reoperation, and mortality. Particular attention will be given to complications potentially related to the duodenoileal anastomosis, including anastomotic leak, bleeding, obstruction, stenosis, ulceration, intra-abdominal collection, and other gastrointestinal complications.
Participants will undergo standardized postoperative clinical and laboratory follow-up for up to 12 months. Weight-related outcomes will include body weight, body mass index (BMI), percentage total weight loss (%TWL), and percentage excess weight loss (%EWL) at predefined postoperative time points. Metabolic assessment will include glycemic measures such as glycated hemoglobin (HbA1c) and changes in treatment requirements among participants with type 2 diabetes mellitus or prediabetes. Changes in other obesity-associated medical conditions, including hypertension and dyslipidemia, will also be documented where applicable.
Nutritional follow-up will include clinically appropriate laboratory assessment of hematological, protein, mineral, and micronutrient parameters according to the institutional metabolic and bariatric surgery follow-up protocol. Gastrointestinal symptoms and clinically relevant postoperative events will be prospectively recorded throughout follow-up.
Where specified in the final study protocol, postoperative imaging may be used to assess anastomotic patency and passage of contrast through the native duodenojejunal and duodenoileal pathways. Any imaging or metabolic investigations performed specifically for research purposes will be predefined in the approved study protocol.
The study is designed as an initial prospective evaluation of the feasibility, safety, and clinical outcomes of SIBS. It is not designed to establish superiority or noninferiority to SADI-S, Roux-en-Y gastric bypass, sleeve gastrectomy, or other established bariatric procedures. Findings from this study are intended to inform subsequent larger and comparative studies evaluating the longer-term effectiveness, metabolic effects, nutritional consequences, and safety of the procedure.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Stapled Intact-Duodenum Bipartition With Sleeve Gastrectomy (SIBS) | Experimental | Procedure: Stapled Intact-Duodenum Bipartition With Sleeve Gastrectomy (SIBS)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 |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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.
Key exclusion criteria (15 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Stapled Intact-Duodenum Bipartition With Sleeve Gastrectomy (SIBS)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. | Procedure or surgery | Stapled Intact-Duodenum Bipartition With Sleeve Gastrectomy (SIBS) |
Primary outcome
Proportion of Participants With Successful Technical Completion of the SIBS Procedure
Time frame: During the index surgical 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.
Proportion of Participants With Major Postoperative Complications Within 30 Days
Time frame: From the day of surgery through postoperative day 30
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.
14 secondary outcomes
Percentage Total Weight Loss (%TWL) at 12 Months
Time frame: 12 months after surgery
Percentage Excess Weight Loss (%EWL) at 12 Months
Time frame: 12 months after surgery
Change in Body Mass Index From Baseline to 12 Months
Time frame: Baseline to 12 months after surgery
Change in Glycated Hemoglobin (HbA1c) From Baseline to 12 Months
Time frame: Baseline to 12 months after surgery
Proportion of Participants With Type 2 Diabetes Remission at 12 Months
Time frame: 12 months after surgery
Operative Time
Time frame: During the index surgical procedure
Estimated Intraoperative Blood Loss
Time frame: During the index surgical procedure
Postoperative Length of Hospital Stay
Time frame: From the day of surgery until hospital discharge, assessed up to 30 days
Proportion of Participants With Unplanned Hospital Readmission Within 30 Days
Time frame: From hospital discharge through postoperative day 30
Proportion of Participants Requiring Unplanned Reoperation Within 30 Days
Time frame: From the day of surgery through postoperative day 30
Proportion of Participants With Duodenoileal Anastomotic Leak Within 30 Days
Time frame: From the day of surgery through postoperative day 30
Proportion of Participants With Duodenoileal Anastomotic Stenosis
Time frame: From surgery through 12 months after surgery
Proportion of Participants With Duodenoileal Anastomotic Ulceration
Time frame: From surgery through 12 months after surgery
Change in Selected Nutritional Laboratory Parameters From Baseline to 12 Months
Time frame: Baseline to 12 months after surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2026.
- Background: PubMed 38704201Cadiere 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.
- Background: PubMed 37393568Gagner 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.
- Background: PubMed 33409979Brown 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.
- Background: PubMed 18040751Sanchez-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.
- Individual participant dataSharing planned: Undecided. Individual participant data are not currently planned for public sharing because of participant confidentiality, the small study population, and institutional data-protection requirements. De-identified aggregate study results will be reported through peer-reviewed publications and scientific presentations in accordance with applicable ethical and institutional requirements.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Mohammed Al Sibani, MD, FRCSC principal investigator
Medical City for Military and Security Services
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Stapled Intact-Duodenum Bipartition With Sleeve Gastrectomy (SIBS) in people with Obesity and Obesity Type 2 Diabetes Mellitus, run by Medical City for Military and Security Services at 1 site in Oman.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 14 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Oman. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mohammed Al Sibani, MD, FRCSC (0096899360515 ext. 0096899360515, med1500@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of Participants With Successful Technical Completion of the SIBS Procedure (time frame: During the index surgical procedure). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07765758, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Aug 2026.