Metabolic Surgery, Obesity & Overweight
Conditions
Keywords
Stapled versus Hand-sewn Technique, SADI-s, Metabolic Bariatric Surgery
Brief summary
This study aims to compare the stapled and handsewn techniques of duodeno-ileal anastomosis in SADI-S regarding short-term outcomes in the form of anastomotic leak rate and anastomotic stricture rate, operative time, post-operative hospital stay, and complication rate (Clavien-Dindo≥ II).
Interventions
PROCEDUREHand-sewn Single Anastomosis Duodeno-Ileal Sleeve (SADI-S)
Arm 1 - Hand-sewn Duodeno-Ileal Anastomosis Following sleeve gastrectomy, a hand-sewn duodeno-ileal anastomosis is performed in two layers, with the inner layer constructed using absorbable barbed sutures and the outer reinforcing layer using absorbable monofilament sutures. Approximately 300 cm of the distal ileum from the ileocecal junction is used for the anastomosis. All procedures are performed by the same surgeon following a standardized operative protocol.
PROCEDUREStapled Single Anastomosis Duodena-ileal Sleeve
Arm 2 - Stapled Single Anastomosis Duodena-ileal Sleeve Following sleeve gastrectomy, a stapled duodeno-ileal anastomosis is created using endoscopic linear stapling devices, followed by closure of the enterotomy in a single layer using absorbable barbed sutures. Approximately 300 cm of the distal ileum from the ileocecal junction is used for the anastomosis. All procedures are performed by the same surgeon following a standardized operative protocol.
Sponsors
Kasr El Aini Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
1. Age between 18-70 2. Patients who will undergo SADI-S surgery
Exclusion criteria
1. Patients with severe medical conditions such as heart failure and interstitial lung disease. 2. Patients with short bowel 3. Patients with severe GERD 4. Patients with cognitive and intellectual impairment with poor compliance to treatment and dietary supplements 5. Difficulty in intraoperative bowel measurement, i.e., extensive adhesions.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Intestinal Injury | One month after surgery |
| Anastomotic Leak Rate | one month after the surgery |
| Post operative Bleeding | One month after surgery |
| Anastomotic Stircture | Six months after surgery |
| Operative Time | Immediately after surgery |
Secondary
| Measure | Time frame |
|---|---|
| Weight loss | Six months after surgery |
| Length of Hosptial Stay | One month after surgery |
Countries
Egypt
Outcome results
None listed