Comparisons of Metabolic Effect of Sleeve Gastrectomy With Duodenojejunal Bypass and Sleeve Gastrectomy (MEDUSA): A Multicenter Randomized Controlled Trial

Summary

In this study, the effects of SG with DJB and SG alone for the treatment of type 2 diabetes mellitus (T2DM) will be compared in patients other than the two groups at both extremes who are expected to show excellent effects of metabolic surgery with SG alone (mild T2DM) and who need SG with DJB (severe T2DM).

This study is to target patients with poor blood sugar control despite current medical treatment, although the beta-cell function of the pancreas is preserved. Therefore, this study is aimed at patients who have been using insulin for less than 10 years with T2DM, or taking diabetic medications with HbA1c ≥ 7.0% for less than 10 years with T2DM.

The investigators hypothesize that the treatment effects of SG with DJB for T2DM will be superior to that of SG in this group

Conditions

• Diabetes Mellitus, Type 2
• Bariatric Surgery
• Surgical Procedures, Operative
• Asians

Interventions

PROCEDURE

Duodenojejunal bypass

Sleeve gastrectomy will be performed in the same manner as in the SG group. DJB will be performed by transection of the duodenum and bypassing 250 cm of the proximal jejunum. The handsewn suture will be used for duodenojejunal anastomosis, and the size of anastomosis will be 1.5 - 2 cm. Single anastomosis will be performed rather than Roux-en-Y fashion.

PROCEDURE

Sleeve gastrectomy

Sleeve gastrectomy will be performed using 36-38 Fr bougie. The initial stapling start point will be between 4-6 cm from the pylorus, and the last stapling will be performed at least 1 cm away from His angle. The height of the automatic stapler will be selected based on the researcher's discretion.

Sponsors & Collaborators

• Ajou University School of Medicine

  collaborator OTHER

• The Catholic University of Korea

  collaborator OTHER

• The Catholic University of Korea Eunpyeong St. Mary's Hospital

  collaborator UNKNOWN

• Ewha University Seoul Hospital

  collaborator UNKNOWN

• Seoul Metropolitan Boramae Hospital

  collaborator UNKNOWN

• Soonchunhyang University Hospital

  collaborator OTHER

• Korea University

  collaborator OTHER

• Seoul National University Bundang Hospital

  lead OTHER

Principal Investigators

• Young Suk Park · Seoul National University Bundang Hospital

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2022-01-03

Primary Completion

2031-01-03

Completion

2036-01-03

Countries

• South Korea

Study Locations