NCT07289555 Tailored Stapled SADI-S: Initial Report and Preliminary Results
| NCT ID | NCT07289555 |
| Status | Recruiting |
| Phase | — |
| Sponsor | El-Sahel Teaching Hospital |
| Condition | Morbid Obesity |
| Study Type | INTERVENTIONAL |
| Enrollment | 40 participants |
| Start Date | 2024-06-01 |
| Primary Completion | 2025-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 40 participants in total. It began in 2024-06-01 with a primary completion date of 2025-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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.
Contact & Investigator
Ahmed M Yousry, Lecturer of Surgery
PRINCIPAL INVESTIGATOR
El Sahel Teaching Hospital, Cairo, Egypt
Frequently Asked Questions
Who can join the NCT07289555 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 65 Years, studying Morbid Obesity. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07289555 currently recruiting?
Yes, NCT07289555 is actively recruiting participants. Contact the research team at ahmed.farid@alexmed.edu.eg for enrollment information.
Where is the NCT07289555 trial being conducted?
This trial is being conducted at Cairo, Egypt.
Who is sponsoring the NCT07289555 clinical trial?
NCT07289555 is sponsored by El-Sahel Teaching Hospital. The principal investigator is Ahmed M Yousry, Lecturer of Surgery at El Sahel Teaching Hospital, Cairo, Egypt. The trial plans to enroll 40 participants.
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