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

September 13, 2024 updated by: Xuehui Chu, The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

A Prospective,Single-center,Randomized,Controlled Study to Evaluate the Efficacy and Safety of SASI Compared with RYGB in the Treatment of Obesity and Related Metabolic Diseases

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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.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.

Study Type

Interventional

Enrollment (Estimated)

304

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Jiangsu
      • Nanjing, Jiangsu, China, 210008
        • Nanjing Drum Tower Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: SASI group
single anastomosis sleeve ileal bypass
Procedure: SASI
single anastomosis sleeve ileal bypass
Experimental: RYGB group
Roux-en-Y gastric bypass
Procedure: RYGB
Roux-en-Y gastric bypass

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of excess weight loss one year after surgery (% EWL)
Time Frame: one year after surgery
Percentage of excess weight loss one year after surgery
one year after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

Investigators

  • Principal Investigator: Xuehui Chu, Doctorate, The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 3, 2024

Primary Completion (Estimated)

January 31, 2027

Study Completion (Estimated)

January 31, 2027

Study Registration Dates

First Submitted

September 11, 2024

First Submitted That Met QC Criteria

September 13, 2024

First Posted (Estimated)

September 19, 2024

Study Record Updates

Last Update Posted (Estimated)

September 19, 2024

Last Update Submitted That Met QC Criteria

September 13, 2024

Last Verified

August 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2024-557

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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