Actively Recruiting
Tailored Stapled SADI-S: Initial Report and Preliminary Results
Led by El-Sahel Teaching Hospital · Updated on 2025-12-17
40
Participants Needed
1
Research Sites
134 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Tailored Stapled SADI-S: Initial Report and Preliminary Results
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 18-65 years
- BMI 35 kg/m2 or higher, or BMI 30 kg/m2 or higher with obesity-related conditions such as type 2 diabetes, hypertension, dyslipidemia, sleep apnea, or fatty liver disease
- Willingness to attend follow-up visits and complete testing
- Candidates for revisional SADI-S after sleeve gastrectomy due to inadequate weight loss or weight regain
You will not qualify if you...
- Severe uncontrolled medical or psychiatric conditions that prevent following the study protocol
- Known short bowel syndrome or previous extensive bowel removal
- Extensive bowel adhesions found during surgery
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
El Sahel Teaching Hospital
Cairo, Greater Cairo, Egypt, 11697
Actively Recruiting
Research Team
A
Ahmed MFMH Mansour, Lecturer of Surgery
CONTACT
M
Mostafa R ElKeleny, Assistant Professor of Surgery
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here