Evaluate the Efficacy and Safety of SASI Compared with RYGB in the Treatment of Obesity and Related Metabolic Diseases

NCT06598267 · tracked via the Priya Life Science China tracker

Sponsor

The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

Phase

Not applicable

Started

2024-09-03

Last updated

2024-09-19

Condition(s) studied

Bariatric Surgery

Investigational drug(s) / intervention(s)

SASIRYGB

SASI: single anastomosis sleeve ileal bypass

RYGB: Roux-en-Y gastric bypass

Study 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 their disadvantages,in order to achieve better treatment outcomes.On the one hand,SASI surgery improves the effectiveness of weight loss surgery by adding gastrointestinal anastomosis on the basis of SG,while reducing gastric pressure and improving postoperative gastroesophageal reflux symptoms.On the other hand,it also avoids the regret of RYGB surgery leaving the stomach open for gastroscopy examination and reduces the risk of postoperative nutrition related complications.Therefore,SASI surgery has demonstrated good application prospects and is expected to be promoted in clinical practice.So far,there has been no comparative study of RCTs between RYGB and SASI internationally.In order to compare the weight loss effects of SASI and RYGB surgery,this study intends to conduct a randomized controlled trial on patients who meet the criteria and require weight loss surgery,providing high-level evidence-based medicine for the further clinical development of SASI surgery in the future.

Eligibility

Sex

ALL

Min age

18 Years

Max age

65 Years

Healthy volunteers

Accepted

Inclusion Criteria: * 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 Criteria: * 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

Primary outcome measure(s)

Percentage of excess weight loss one year after surgery (% EWL) — one year after surgery
Percentage of excess weight loss one year after surgery

Trial sites (1)

Facility	City	Region	Status
Nanjing Drum Tower Hospital	Nanjing	Jiangsu

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06598267 on ClinicalTrials.gov ↗ ← All trials in China