Prospective Evaluation of Stapled Intact-Duodenum Bipartition With Sleeve Gastrectomy (SIBS) (SIBS)
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
調査の概要
状態
状態
条件
条件
介入・治療
介入・治療
詳細な説明
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.
研究の種類
研究の種類
入学 (推定)
入学
段階
段階
- 適用できない
連絡先と場所
研究連絡先
研究連絡先
- 名前：Mohammed Al Sibani, MD, FRCSC
- 電話番号：0096899360515 0096899360515
- メール：med1500@yahoo.com
研究連絡先のバックアップ
- 名前：Younis Al-Mufargi, MD
- 電話番号：0096895622838 0096895622838
- メール：hashyounis96@gmail.com
研究場所
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Muscat、オマーン、111
- Division of Bariatric and Metabolic Surgery, Medical City for Military and Security Services
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コンタクト：
- Mohammed Al Sibani, MD, FRCSC
- 電話番号：+96899360515
- メール：med1500@yahoo.com
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主任研究者：
- Mohammed Al Sibani, MD, FRCSC
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主任研究者：
- Wael Arba, MD, DEMS GS ALG
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主任研究者：
- Mohsin Alriyami, MD, OMSB
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副調査官：
- Jasper Viloria, MD, FICS
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副調査官：
- Ruzdi Farouk, MBBS, MRCS
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主任研究者：
- Younis Al-Mufargi, MD
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参加基準
適格基準
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
説明
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.
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：なし
- 介入モデル：単一グループの割り当て
- マスキング：なし（オープンラベル）
アーム数
武器と介入
参加者グループ / アーム参加者グループ / アーム |
介入・治療介入・治療 |
|---|---|
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実験的：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
|
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.
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この研究は何を測定していますか？
主要な結果の測定
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Proportion of Participants With Successful Technical Completion of the SIBS Procedure
時間枠：During the index surgical procedure
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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.
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During the index surgical procedure
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Proportion of Participants With Major Postoperative Complications Within 30 Days
時間枠：From the day of surgery through postoperative day 30
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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.
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From the day of surgery through postoperative day 30
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二次結果の測定
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Percentage Total Weight Loss (%TWL) at 12 Months
時間枠：12 months after surgery
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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.
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12 months after surgery
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Percentage Excess Weight Loss (%EWL) at 12 Months
時間枠：12 months after surgery
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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.
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12 months after surgery
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Change in Body Mass Index From Baseline to 12 Months
時間枠：Baseline to 12 months after surgery
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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.
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Baseline to 12 months after surgery
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Change in Glycated Hemoglobin (HbA1c) From Baseline to 12 Months
時間枠：Baseline to 12 months after surgery
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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.
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Baseline to 12 months after surgery
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Proportion of Participants With Type 2 Diabetes Remission at 12 Months
時間枠：12 months after surgery
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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.
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12 months after surgery
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Operative Time
時間枠：During the index surgical procedure
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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.
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During the index surgical procedure
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Estimated Intraoperative Blood Loss
時間枠：During the index surgical procedure
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Estimated blood loss during the index surgical procedure will be recorded in milliliters and summarized using appropriate measures of central tendency and variability.
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During the index surgical procedure
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Postoperative Length of Hospital Stay
時間枠：From the day of surgery until hospital discharge, assessed up to 30 days
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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.
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From the day of surgery until hospital discharge, assessed up to 30 days
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Proportion of Participants With Unplanned Hospital Readmission Within 30 Days
時間枠：From hospital discharge through postoperative day 30
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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.
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From hospital discharge through postoperative day 30
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Proportion of Participants Requiring Unplanned Reoperation Within 30 Days
時間枠：From the day of surgery through postoperative day 30
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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.
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From the day of surgery through postoperative day 30
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Proportion of Participants With Duodenoileal Anastomotic Leak Within 30 Days
時間枠：From the day of surgery through postoperative day 30
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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.
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From the day of surgery through postoperative day 30
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Proportion of Participants With Duodenoileal Anastomotic Stenosis
時間枠：From surgery through 12 months after surgery
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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.
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From surgery through 12 months after surgery
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Proportion of Participants With Duodenoileal Anastomotic Ulceration
時間枠：From surgery through 12 months after surgery
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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.
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From surgery through 12 months after surgery
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Change in Selected Nutritional Laboratory Parameters From Baseline to 12 Months
時間枠：Baseline to 12 months after surgery
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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.
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Baseline to 12 months after surgery
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その他の成果指標
その他の成果指標
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Proportion of Participants With Contrast Passage Through Both Gastrointestinal Pathways
時間枠：At protocol-specified postoperative contrast imaging, within 3 months after surgery
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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.
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At protocol-specified postoperative contrast imaging, within 3 months after surgery
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協力者と研究者
捜査官
捜査官
- 主任研究者：Mohammed Al Sibani, MD, FRCSC、Medical City for Military and Security Services
出版物と役立つリンク
一般刊行物
- 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.
- 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.
- 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.
- 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.
研究記録日
主要日程の研究
研究開始 (推定)
研究開始
一次修了 (推定)
一次修了
研究の完了 (推定)
研究の完了
試験登録日
最初に提出
最初に提出
QC基準を満たした最初の提出物
QC基準を満たした最初の提出物
最初の投稿 (実際)
最初の投稿
学習記録の更新
投稿された最後の更新 (実際)
投稿された最後の更新
QC基準を満たした最後の更新が送信されました
QC基準を満たした最後の更新が送信されました
最終確認日
最終確認日
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本研究に関する用語
キーワード
その他の研究ID番号
その他の研究ID番号
- MCMSS-MREC 80/2026
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
IPD プランの説明
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
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