Personalized stapled SADI-S operation with tailored bypass length

Tailored Stapled Single Anastomosis Duodeno-ileal Bypass With Sleeve Gastrectomy (SADI-S): Initial Report and Preliminary Results

This trial tests a personalized SADI‑S operation that adjusts the length of the bypassed intestine to try to improve weight loss and lower the risk of vitamin and nutrient deficiencies in adults needing revisional surgery after a sleeve gastrectomy.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 40 (estimated)
• Ages: 18 Years to 65 Years
• Sex: All
• Sponsor: El-Sahel Teaching Hospital (other gov)
• Locations: 1 site (Cairo, Greater Cairo)
• Trial ID: NCT07289555 on ClinicalTrials.gov

What this trial studies

This single-center interventional protocol uses Single-Anastomosis Duodeno-Ileal Bypass with Sleeve Gastrectomy (SADI‑S) performed with a stapled technique and an intraoperative, patient-specific adjustment of the bypassed small‑bowel length. Eligible adults who previously had sleeve gastrectomy and show inadequate weight loss or weight regain undergo the revisional procedure and regular postoperative follow-up for weight, metabolic outcomes, and nutritional markers. The team tracks weight-loss metrics, comorbidity changes, and laboratory measures of vitamin and protein status to compare outcomes with historical norms. The work aims to balance effective weight loss with lower rates of malabsorption-related complications by personalizing limb length.

Who should consider this trial

Good fit: Adults 18–65 years with BMI ≥35 kg/m² (or ≥30 kg/m² with obesity-related comorbidities) who previously had sleeve gastrectomy and are indicated for revisional SADI‑S for inadequate weight loss or weight regain are the intended participants.

Not a fit: Patients with known short bowel syndrome, prior extensive bowel resections, severe uncontrolled medical or psychiatric conditions, or those unable to attend required follow-up are unlikely to benefit from this protocol.

Why it matters

Potential benefit: If successful, personalizing the bypass length could produce strong weight loss while reducing long-term vitamin and protein deficiencies compared with a one-size-fits-all bypass length.

How similar studies have performed: SADI‑S has shown strong weight-loss and metabolic benefits in prior reports, but tailoring the limb length intraoperatively is a newer modification with limited long-term published data.

Eligibility criteria

Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Where this trial is running

Cairo, Greater Cairo

• El Sahel Teaching Hospital — Cairo, Greater Cairo, Egypt (RECRUITING)

Study contacts

• Principal investigator: Ahmed M Yousry, Lecturer of Surgery — El Sahel Teaching Hospital, Cairo, Egypt
• Study coordinator: Ahmed MFMH Mansour, Lecturer of Surgery

Conditions: Morbid Obesity, Bariatric Surgery, Malnutrition, Comorbidities, SADI-S, Bariatric surgery, Limb length tailoring, Weight loss outcomes