Comparisons of Metabolic Effect of Sleeve Gastrectomy With Duodenojejunal Bypass and Sleeve Gastrectomy (MEDUSA): A Multicenter Randomized Controlled Trial
Seoul National University Bundang Hospital
130 participants
Jan 3, 2022
INTERVENTIONAL
Conditions
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
Eligibility
Inclusion Criteria8
- Age over 18 years
- BMI equal to or greater than 27.5 kg/m2
- T2DM duration ≤ 10 years
- Using insulin, or HbA1c ≥ 7.0% while taking diabetes medication
- C-peptide level higher than 1.0 ng/mL
- Presence of type 2 diabetes fulfilling the following criteria
- Consent to not become pregnant for at least 1 year after surgery
- Willingness to provide voluntary informed consent
Exclusion Criteria8
- Presence of uncontrolled severe gastroesophageal reflux (LA classification C or more in esophagogastroduodenoscopy)
- History of previous metabolic surgery for T2DM
- History of gastrointestinal surgery, such as gastrectomy or anti-reflux surgery, which may affect the result of metabolic surgery
- Therapy regimen of more than 3 psychiatric drugs owing to poorly controlled psychiatric disorders
- Suicidal attempts within the last 12 months
- Treatment for alcohol and drug abuse within the last 12 months
- Vulnerability factors (lacking mental capacity, pregnancy or planning of pregnancy, lactation)
- Unsuitability as per the discretion of the researcher
Interventions
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.
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.
Locations(1)
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NCT05211375