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

NCT06598267 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 304

Last updated 2024-09-19

No results posted yet for this 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.

Conditions

  • Bariatric Surgery

Interventions

PROCEDURE

SASI

single anastomosis sleeve ileal bypass

PROCEDURE

RYGB

Roux-en-Y gastric bypass

Sponsors & Collaborators

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

    lead OTHER

Principal Investigators

  • Xuehui Chu, Doctorate · The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-09-03
Primary Completion
2027-01-31
Completion
2027-01-31

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06598267 on ClinicalTrials.gov