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

Nanjing University

Status

Active, not recruiting

Conditions

Bariatric Surgery

Treatments

Procedure: SASI

Procedure: RYGB

Study type

Interventional

Funder types

Other

Identifiers

NCT06598267

2024-557

Details and patient eligibility

About

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.

Full 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.Patients who meet the inclusion criteria will receive informed consent before enrollment and be randomly assigned to either the experimental group (SASI group) or the control group (RYGB group) for weight loss surgery based on computer randomization results.

Monitor the patient's surgical condition and surgical complications before discharge.

Follow up will be conducted at each follow-up node after surgery (1 month/3 months/6 months/12 months).

This study aims to measure the weight of patients before and after surgery, analyze the degree of weight loss based on the percentage of excess weight loss (% EWL) one year after surgery, and compare the weight loss effects of two surgical procedures.At the same time,based on relevant laboratory results,the effectiveness of two surgical procedures for treating metabolic syndrome,the incidence of postoperative nutritional complications,the incidence of surgical related complications,the quality of life one year after surgery,and weight loss were compared.

Enrollment

304 estimated patients

Sex

All

Ages

18 to 65 years old

Volunteers

Accepts Healthy Volunteers

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