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Safety and clinical efficacy of laparoscopic sleeve gastrectomy versus laparoscopic sleeve gastrectomy plus jejunojejunal bypass: a single-center, prospective randomized controlled trial

Safety and clinical efficacy of laparoscopic sleeve gastrectomy versus laparoscopic sleeve gastrectomy plus jejunojejunal bypass: a single-center, prospective randomized controlled trial

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400082089
Enrollment
Unknown
Registered
2024-03-20
Start date
2023-05-19
Completion date
Unknown
Last updated
2024-03-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Obesity

Interventions

Experimental group:Laparoscopic sleeve gastrectomy plus jejunojejunal bypass
Control group:Laparoscopic sleeve gastrectomy

Sponsors

Sir Run Run Shaw Hospital, School of Medicine, Zhejiang University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 60 Years

Inclusion criteria

Inclusion criteria: (1) 40kg/?=BMI=50kg/?. (2) Age 18 to 60 years old. (3) ECOG score 0-1. (4) Laparoscopic bariatric metabolic surgery was planned and both surgical modalities in the protocol were voluntarily accepted. (5) Voluntary participation in the study and signing of the informed consent form.

Exclusion criteria

Exclusion criteria: (1) A definite diagnosis of type 1 diabetes or other special types of diabetes. (2) In patients with type 2 diabetes mellitus, the function of islet B cells has been basically lost. (3) Reflux esophagitis is Los Angeles classification grade B or higher or Barrett's esophagus. (4) Pregnancy. (5) Drug or alcohol abuse or uncontrollable mental illness. (6) Mental retardation or immaturity, inability to control behavior, or inability to understand the project. (7) The expectation of surgery is not in line with reality or is unwilling to bear the risk of potential complications of surgery. (8) Those who are unable to cooperate with the changes in diet and living habits after surgery and have poor compliance. (9) Severe gastrointestinal disease (such as inflammatory bowel disease), history of major abdominal surgery or contraindications to general anesthesia surgery (such as recent stroke history, serious cardiac-related diseases, etc.). (10) Previous bariatric surgery of any kind.

Design outcomes

Primary

MeasureTime frame
Weight;Postoperative complications;% Total weight loss;%Excess weight loss;—

Secondary

MeasureTime frame
HbA1c;fast blood glucose;LDL-C;HDL-C;TG;TC;blood pressure;lumbar vertebrae bone mineral density;Polycystic ovary syndrome;Quality of life;Vitamin;zinc;—

Countries

China

Contacts

Public ContactYu Weihua

Sir Run Run Shaw Hospital, School of Medicine, Zhejiang University

srrshwhy@zju.edu.cn+86 571 8788 8390

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026