Tailored Stapled SADI-S: Initial Report and Preliminary Results

NCT07289555 | Recruiting

• 1 other identifier: 0307473
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

Obesity is a serious health problem worldwide and can lead to many diseases such as diabetes, high blood pressure, heart disease, and sleep apnea. When lifestyle changes and medications are not enough, metabolic and bariatric surgery (MBS) is currently the most effective and long-lasting treatment option. This study focuses on one of the newer types of bariatric surgery called Single Anastomosis Duodeno-Ileal Bypass with Sleeve Gastrectomy (SADI-S). This procedure combines two parts: Sleeve gastrectomy, which reduces the size of the stomach so the patient feels full after eating a small amount. Duodeno-ileal bypass, which shortens the path food takes through the small intestine to reduce calorie absorption. Our hospital's surgical team is studying a tailored version of this operation, where the length of the bypassed intestine is adjusted to each patient's anatomy. We believe this personalized approach may improve weight loss results while lowering the risk of vitamin and nutrient deficiencies. The study will include 40 adult patients with obesity who are undergoing SADI-S surgery, either as their first weight loss operation or as a revision surgery after an earlier sleeve gastrectomy. During the operation, surgeons will measure the total length of each patient's small intestine and use a formula to decide how much of it should be bypassed. The duodeno-ileal connection will be made using a stapled technique, which is expected to be safe and efficient. After surgery, patients will be followed regularly at 1, 3, 6, 9, and 12 months, and then once per year. At each visit, the study team will monitor weight loss, body mass index (BMI), resolution of diabetes and other obesity-related conditions, nutritional status (including vitamins and minerals), and any side effects such as diarrhea, reflux, or nutritional problems. The goal of this study is to learn whether this tailored SADI-S technique can provide strong, sustained weight loss and health improvement with fewer long-term complications. The results will help improve surgical planning for future patients by showing whether measuring and customizing the bypass length is safer and more effective than using a fixed length. All data collected will be kept confidential. Patients' participation in the study will not change their regular care or follow-up, and they can withdraw at any time without affecting their treatment.

Conditions

Morbid Obesity; Bariatric Surgery; Malnutrition; Comorbidities

Keywords

SADI-S; Bariatric surgery; Limb length tailoring; Weight loss outcomes; Nutritional status

Outcome Measures

Primary Outcomes (2)

• Weight loss effectiveness

  Change in weight

  6 months,1year, 2 years, 3 years, 4 years and 5 years

• Incidence of postoperative symptoms

  Vomiting, diarrhea, weakness, etc.

  6 months,1year, 2 years, 3 years, 4 years and 5 years

Secondary Outcomes (2)

• Nutritional status and its correlation with limb length

  6 months,1year, 2 years, 3 years, 4 years and 5 years

• Safety of stapled anastomosis

  6 months,1year, 2 years, 3 years, 4 years and 5 years

Study Arms (1)

Patients with morbid obesity

OTHER

Tailored SADI-S

Procedure: Bariatric surgery

Interventions

Bariatric surgery PROCEDURE

Only surgical procedure in the study

Also known as: SADI-S

Patients with morbid obesity

Eligibility Criteria

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

You may qualify if:

• Adults aged 18-65 years.
• BMI ≥35 kg/m² or BMI ≥30 kg/m² with obesity-related comorbidities such as type 2 diabetes mellitus (T2DM), hypertension, dyslipidemia, obstructive sleep apnea, or non-alcoholic fatty liver disease.
• Willingness to adhere to follow-up visits and testing.
• Indicated for revisional SADI-S post sleeve gastrectomy for inadequate weight loss or weight regain.

You may not qualify if:

• Severe uncontrolled medical or psychiatric conditions preventing adherence to the protocol.
• Known short bowel syndrome or previous extensive bowel resections or intraoperative finding of extensive bowel adhesions.

Sponsors & Collaborators

• El-Sahel Teaching Hospital: lead

Study Sites (1)

El Sahel Teaching Hospital

Cairo, Greater Cairo, 11697, Egypt

RECRUITING

Related Publications (15)

• Man J, Hrabe J. Anastomotic Technique-How to Optimize Success and Minimize Leak Rates. Clin Colon Rectal Surg. 2021 Nov 23;34(6):371-378. doi: 10.1055/s-0041-1735267. eCollection 2021 Nov.

  PMID: 34853557 BACKGROUND

• Liagre A, Martini F, Anduze Y, Boudrie H, Van Haverbeke O, Valabrega S, Kassir R, Debs T, Petrucciani N. Efficacy and Drawbacks of Single-Anastomosis Duodeno-Ileal Bypass After Sleeve Gastrectomy in a Tertiary Referral Bariatric Center. Obes Surg. 2021 Jun;31(6):2691-2700. doi: 10.1007/s11695-021-05323-y. Epub 2021 Apr 9.

  PMID: 33834374 BACKGROUND

• Salman MA, Abelsalam A, Nashed GA, Yacoub M, Abdalla A. Long Biliopancreatic Limb Roux-En-Y Gastric Bypass Versus One-Anastomosis Gastric Bypass: a Randomized Controlled Study. Obes Surg. 2023 Jul;33(7):1966-1973. doi: 10.1007/s11695-023-06631-1. Epub 2023 May 13.

  PMID: 37178225 BACKGROUND

• van der Voort M, Heijnsdijk EA, Gouma DJ. Bowel injury as a complication of laparoscopy. Br J Surg. 2004 Oct;91(10):1253-8. doi: 10.1002/bjs.4716.

  PMID: 15376204 BACKGROUND

• Mahawar KK, Parmar C, Carr WRJ, Jennings N, Schroeder N, Small PK. Impact of biliopancreatic limb length on severe protein-calorie malnutrition requiring revisional surgery after one anastomosis (mini) gastric bypass. J Minim Access Surg. 2018 Jan-Mar;14(1):37-43. doi: 10.4103/jmas.JMAS_198_16.

  PMID: 28695878 BACKGROUND

• Pereira AM, Moura D, Pereira SS, Andrade S, Almeida RF, Nora M, Monteiro MP, Guimaraes M. Beyond Restrictive: Sleeve Gastrectomy to Single Anastomosis Duodeno-Ileal Bypass with Sleeve Gastrectomy as a Spectrum of One Single Procedure. Obes Facts. 2024;17(4):364-371. doi: 10.1159/000539104. Epub 2024 May 27.

  PMID: 38801818 BACKGROUND

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

  PMID: 33409979 BACKGROUND

• Gazer B, Rosin D, Bar-Zakai B, Willenz U, Doron O, Gutman M, Nevler A. Accuracy and inter-operator variability of small bowel length measurement at laparoscopy. Surg Endosc. 2017 Nov;31(11):4697-4704. doi: 10.1007/s00464-017-5538-5. Epub 2017 Apr 13.

  PMID: 28409379 BACKGROUND

• Madan AK, Harper JL, Tichansky DS. Techniques of laparoscopic gastric bypass: on-line survey of American Society for Bariatric Surgery practicing surgeons. Surg Obes Relat Dis. 2008 Mar-Apr;4(2):166-72; discussion 172-3. doi: 10.1016/j.soard.2007.08.006. Epub 2007 Dec 19.

  PMID: 18069071 BACKGROUND

• Tacchino RM. Bowel length: measurement, predictors, and impact on bariatric and metabolic surgery. Surg Obes Relat Dis. 2015 Mar-Apr;11(2):328-34. doi: 10.1016/j.soard.2014.09.016. Epub 2014 Sep 30.

  PMID: 25614357 BACKGROUND

• Kallies K, Rogers AM; American Society for Metabolic and Bariatric Surgery Clinical Issues Committee. American Society for Metabolic and Bariatric Surgery updated statement on single-anastomosis duodenal switch. Surg Obes Relat Dis. 2020 Jul;16(7):825-830. doi: 10.1016/j.soard.2020.03.020. Epub 2020 Mar 30. No abstract available.

  PMID: 32371036 BACKGROUND

• Ferraris RP. Dietary and developmental regulation of intestinal sugar transport. Biochem J. 2001 Dec 1;360(Pt 2):265-76. doi: 10.1042/0264-6021:3600265.

  PMID: 11716754 BACKGROUND

• Sanchez-Pernaute A, Herrera MA, Perez-Aguirre ME, Talavera P, Cabrerizo L, Matia P, Diez-Valladares L, Barabash A, Martin-Antona E, Garcia-Botella A, Garcia-Almenta EM, Torres A. Single anastomosis duodeno-ileal bypass with sleeve gastrectomy (SADI-S). One to three-year follow-up. Obes Surg. 2010 Dec;20(12):1720-6. doi: 10.1007/s11695-010-0247-3.

  PMID: 20798995 BACKGROUND

• Clapp B, Ponce J, Corbett J, Ghanem OM, Kurian M, Rogers AM, Peterson RM, LaMasters T, English WJ. American Society for Metabolic and Bariatric Surgery 2022 estimate of metabolic and bariatric procedures performed in the United States. Surg Obes Relat Dis. 2024 May;20(5):425-431. doi: 10.1016/j.soard.2024.01.012. Epub 2024 Feb 1.

  PMID: 38448343 BACKGROUND

• Eisenberg D, Shikora SA, Aarts E, Aminian A, Angrisani L, Cohen RV, de Luca M, Faria SL, Goodpaster KPS, Haddad A, Himpens JM, Kow L, Kurian M, Loi K, Mahawar K, Nimeri A, O'Kane M, Papasavas PK, Ponce J, Pratt JSA, Rogers AM, Steele KE, Suter M, Kothari SN. 2022 American Society of Metabolic and Bariatric Surgery (ASMBS) and International Federation for the Surgery of Obesity and Metabolic Disorders (IFSO) Indications for Metabolic and Bariatric Surgery. Obes Surg. 2023 Jan;33(1):3-14. doi: 10.1007/s11695-022-06332-1.

  PMID: 36336720 BACKGROUND

MeSH Terms

Conditions

Obesity, Morbid; Malnutrition

Interventions

Bariatric Surgery

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Bariatrics; Obesity Management; Therapeutics; Surgical Procedures, Operative

Study Officials

• Ahmed M Yousry, Lecturer of Surgery

  El Sahel Teaching Hospital, Cairo, Egypt

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ahmed MFMH Mansour, Lecturer of Surgery

CONTACT

00201227196753; ahmed.farid@alexmed.edu.eg

Mostafa R ElKeleny, Assistant Professor of Surgery

CONTACT

00201005814622; mostafa.refaie@alexmed.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr

Model Details: Single centre, prospective

Study Record Dates

• First Submitted: November 24, 2025
• First Posted: December 17, 2025
• Study Start: June 1, 2024
• Primary Completion: December 31, 2025
• Study Completion (Estimated): December 31, 2026
• Last Updated: December 17, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)