Status:
ACTIVE_NOT_RECRUITING
Evaluate the Efficacy and Safety of SASI Compared with RYGB in the Treatment of Obesity and Related Metabolic Diseases
Lead Sponsor:
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Conditions:
Bariatric Surgery
Eligibility:
All Genders
18-65 years
Phase:
NA
Brief Summary
Single anastomosis sleeve ileal bypass (SASI) is an improved surgical technique for sleeve gastrectomy (SG), which combines the advantages of SG and Roux-en-Y gastric bypass (RYGB) while avoiding thei...
Detailed Description
Routine preoperative examinations should be conducted on patients planning to undergo weight loss surgery,and inclusion screening should be conducted according to the inclusion and exclusion criteria....
Eligibility Criteria
Inclusion
- Patients undergoing weight loss surgery,aged 18-65 years old
- Simple obesity with a BMI exceeding 35 or a BMI exceeding 32 combined with at least 2 metabolic syndromes
- Preoperative gastroscopy examination showed no high-risk factors for gastric cancer
- Preoperative multidisciplinary evaluation is suitable for gastric bypass or dual channel surgery
- Patients understand and accept long-term follow-up
- The patient agrees to participate in the clinical study and signs an informed consent form
Exclusion
- The patient has type 1 diabetes
- Gastroscopy indicates active gastroduodenal ulcers within the past 2 months without treatment
- The patient has a history of chronic inflammatory bowel disease
- The patient is pregnant or has a recent pregnancy plan
- Having psychological disorders that require monitoring
- The patient has undergone weight loss surgery in the past to undergo corrective surgery
Key Trial Info
Start Date :
September 3 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 31 2027
Estimated Enrollment :
304 Patients enrolled
Trial Details
Trial ID
NCT06598267
Start Date
September 3 2024
End Date
January 31 2027
Last Update
September 19 2024
Active Locations (1)
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1
Nanjing Drum Tower Hospital
Nanjing, Jiangsu, China, 210008