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

2026. augusztus 11. frissítette: Mohammed Al Sibani, Medical City for Military and Security Services

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.

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

A tanulmány áttekintése

Állapot

Még nincs toborzás

Körülmények

Beavatkozás / kezelés

Részletes leírás

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.

Tanulmány típusa

Beavatkozó

Beiratkozás (Becsült)

50

Fázis

  • Nem alkalmazható

Kapcsolatok és helyek

Ez a rész a vizsgálatot végzők elérhetőségeit, valamint a vizsgálat lefolytatásának helyére vonatkozó információkat tartalmazza.

Tanulmányi kapcsolat

  • Név: Mohammed Al Sibani, MD, FRCSC
  • Telefonszám: 0096899360515 0096899360515
  • E-mail: med1500@yahoo.com

Tanulmányozza a kapcsolattartók biztonsági mentését

Tanulmányi helyek

  • Omán
      • Muscat, Omán, 111
        • Division of Bariatric and Metabolic Surgery, Medical City for Military and Security Services
        • Kapcsolatba lépni:
        • Kutatásvezető:
          • Mohammed Al Sibani, MD, FRCSC
        • Kutatásvezető:
          • Wael Arba, MD, DEMS GS ALG
        • Kutatásvezető:
          • Mohsin Alriyami, MD, OMSB
        • Alkutató:
          • Jasper Viloria, MD, FICS
        • Alkutató:
          • Ruzdi Farouk, MBBS, MRCS
        • Kutatásvezető:
          • Younis Al-Mufargi, MD

Részvételi kritériumok

A kutatók olyan embereket keresnek, akik megfelelnek egy bizonyos leírásnak, az úgynevezett jogosultsági kritériumoknak. Néhány példa ezekre a kritériumokra a személy általános egészségi állapota vagy a korábbi kezelések.

Jogosultsági kritériumok

Tanulmányozható életkorok

  • Felnőtt
  • Idősebb felnőtt

Egészséges önkénteseket fogad

Nem

Leírás

Inclusion Criteria

  • 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.

Exclusion Criteria

  • 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.

Tanulási terv

Ez a rész a vizsgálati terv részleteit tartalmazza, beleértve a vizsgálat megtervezését és a vizsgálat mérését.

Hogyan készül a tanulmány?

Tervezési részletek

  • Elsődleges cél: Kezelés
  • Kiosztás: N/A
  • Beavatkozó modell: Egyetlen csoportos hozzárendelés
  • Maszkolás: Nincs (Open Label)

Fegyverek és beavatkozások

Résztvevő csoport / kar
Beavatkozás / kezelés
Kísérleti: 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
Eljárás: 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.

Mit mér a tanulmány?

Elsődleges eredményintézkedések

Eredménymérő
Intézkedés leírása
Időkeret
Proportion of Participants With Successful Technical Completion of the SIBS Procedure
Időkeret: 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.
During the index surgical procedure
Proportion of Participants With Major Postoperative Complications Within 30 Days
Időkeret: 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.
From the day of surgery through postoperative day 30

Másodlagos eredményintézkedések

Eredménymérő
Intézkedés leírása
Időkeret
Percentage Total Weight Loss (%TWL) at 12 Months
Időkeret: 12 months after surgery
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.
12 months after surgery
Percentage Excess Weight Loss (%EWL) at 12 Months
Időkeret: 12 months after surgery
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.
12 months after surgery
Change in Body Mass Index From Baseline to 12 Months
Időkeret: Baseline to 12 months after surgery
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.
Baseline to 12 months after surgery
Change in Glycated Hemoglobin (HbA1c) From Baseline to 12 Months
Időkeret: Baseline to 12 months after surgery
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.
Baseline to 12 months after surgery
Proportion of Participants With Type 2 Diabetes Remission at 12 Months
Időkeret: 12 months after surgery
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.
12 months after surgery
Operative Time
Időkeret: During the index surgical procedure
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.
During the index surgical procedure
Estimated Intraoperative Blood Loss
Időkeret: During the index surgical procedure
Estimated blood loss during the index surgical procedure will be recorded in milliliters and summarized using appropriate measures of central tendency and variability.
During the index surgical procedure
Postoperative Length of Hospital Stay
Időkeret: From the day of surgery until hospital discharge, assessed up to 30 days
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.
From the day of surgery until hospital discharge, assessed up to 30 days
Proportion of Participants With Unplanned Hospital Readmission Within 30 Days
Időkeret: From hospital discharge through postoperative day 30
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.
From hospital discharge through postoperative day 30
Proportion of Participants Requiring Unplanned Reoperation Within 30 Days
Időkeret: From the day of surgery through postoperative day 30
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.
From the day of surgery through postoperative day 30
Proportion of Participants With Duodenoileal Anastomotic Leak Within 30 Days
Időkeret: From the day of surgery through postoperative day 30
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.
From the day of surgery through postoperative day 30
Proportion of Participants With Duodenoileal Anastomotic Stenosis
Időkeret: From surgery through 12 months after surgery
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.
From surgery through 12 months after surgery
Proportion of Participants With Duodenoileal Anastomotic Ulceration
Időkeret: From surgery through 12 months after surgery
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.
From surgery through 12 months after surgery
Change in Selected Nutritional Laboratory Parameters From Baseline to 12 Months
Időkeret: Baseline to 12 months after surgery
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.
Baseline to 12 months after surgery

Egyéb eredményintézkedések

Eredménymérő
Intézkedés leírása
Időkeret
Proportion of Participants With Contrast Passage Through Both Gastrointestinal Pathways
Időkeret: At protocol-specified postoperative contrast imaging, within 3 months after surgery
In participants undergoing protocol-specified postoperative upper gastrointestinal contrast imaging, passage of contrast through the native pyloro-duodenojejunal pathway and through the side-to-side duodenoileal pathway will be assessed. Dual-pathway patency will be defined as visualization of contrast passage through both routes without evidence of anastomotic obstruction. The number and percentage of evaluable participants demonstrating dual-pathway passage will be reported.
At protocol-specified postoperative contrast imaging, within 3 months after surgery

Együttműködők és nyomozók

Itt találhatja meg a tanulmányban érintett személyeket és szervezeteket.

Szponzor

Medical City for Military and Security Services

Nyomozók

  • Kutatásvezető: Mohammed Al Sibani, MD, FRCSC, Medical City for Military and Security Services

Publikációk és hasznos linkek

A vizsgálattal kapcsolatos információk beviteléért felelős személy önkéntesen bocsátja rendelkezésre ezeket a kiadványokat. Ezek bármiről szólhatnak, ami a tanulmányhoz kapcsolódik.

Általános kiadványok

Tanulmányi rekorddátumok

Ezek a dátumok nyomon követik a ClinicalTrials.gov webhelyre benyújtott vizsgálati rekordok és összefoglaló eredmények benyújtásának folyamatát. A vizsgálati feljegyzéseket és a jelentett eredményeket a Nemzeti Orvostudományi Könyvtár (NLM) felülvizsgálja, hogy megbizonyosodjon arról, hogy megfelelnek-e az adott minőség-ellenőrzési szabványoknak, mielőtt közzéteszik őket a nyilvános weboldalon.

Tanulmány főbb dátumok

Tanulmány kezdete (Becsült)

2026. augusztus 1.

Elsődleges befejezés (Becsült)

2027. január 1.

A tanulmány befejezése (Becsült)

2027. december 31.

Tanulmányi regisztráció dátumai

Először benyújtva

2026. augusztus 11.

Először nyújtották be, amely megfelel a minőségbiztosítási kritériumoknak

2026. augusztus 11.

Első közzététel (Tényleges)

2026. augusztus 14.

Tanulmányi rekordok frissítései

Utolsó frissítés közzétéve (Tényleges)

2026. augusztus 14.

Az utolsó frissítés elküldve, amely megfelel a minőségbiztosítási kritériumoknak

2026. augusztus 11.

Utolsó ellenőrzés

2026. augusztus 1.

Több információ

A tanulmányhoz kapcsolódó kifejezések

Kulcsszavak

További vonatkozó MeSH feltételek

Egyéb vizsgálati azonosító számok

  • MCMSS-MREC 80/2026

Terv az egyéni résztvevői adatokhoz (IPD)

Tervezi megosztani az egyéni résztvevői adatokat (IPD)?

ELDÖNTETLEN

IPD terv leírása

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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Egy amerikai FDA által szabályozott eszközterméket tanulmányoz

Nem

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