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

NCT06598267 | Active Not Recruiting DMC

• 1 other identifier: 2024-557
• Study Type: interventional
• Target: 304
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Bariatric Surgery

Keywords

Obesity and Related Metabolic Disease

Outcome Measures

Primary Outcomes (1)

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

  Percentage of excess weight loss one year after surgery

  one year after surgery

Study Arms (2)

SASI group

EXPERIMENTAL

single anastomosis sleeve ileal bypass

Procedure: SASI

RYGB group

EXPERIMENTAL

Roux-en-Y gastric bypass

Procedure: RYGB

Interventions

SASI PROCEDURE

single anastomosis sleeve ileal bypass

SASI group

RYGB PROCEDURE

Roux-en-Y gastric bypass

RYGB group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School: lead

Study Sites (1)

Nanjing Drum Tower Hospital

Nanjing, Jiangsu, 210008, China

Location

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Xuehui Chu, Doctorate

  The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief physician

Study Record Dates

• First Submitted: September 11, 2024
• First Posted: September 19, 2024
• Study Start: September 3, 2024
• Primary Completion (Estimated): January 31, 2027
• Study Completion (Estimated): January 31, 2027
• Last Updated: September 19, 2024

Record last verified: 2024-08

Locations

CN (1)