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Safety and efficacy of indication expansion of laparoscopic sleeve gastrectomy with duodenal-jejunal bypass for obese patients with diabetes mellitus

Safety and efficacy of indication expansion of laparoscopic sleeve gastrectomy with duodenal-jejunal bypass for obese patients with diabetes mellitus - Safety and efficacy of indication expansion of laparoscopic sleeve gastrectomy with duodenal-jejunal bypass for obese patients with diabetes mellitus

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000044786
Enrollment
15
Registered
2021-07-08
Start date
2021-08-01
Completion date
Unknown
Last updated
2026-06-29

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

Conditions

Obese patients with diabetes mellitus

Interventions

Opetarion (indication expansion, BMI&gt
27.5) Laparoscopic sleeve gastrectomy with duodenal-jejunal bypass

Sponsors

Tohoku University Hospital
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1, Age: 20-65 years of age 2, Gender: unquestioned 3, BMI: 32Kg/m2 or more 4, Less than 5 points in the m-ABCD score 5, including patients whose effects after laparoscopic sleeve-gastrectomy are not sufficient, satisfying above criteria 1-4

Exclusion criteria

Exclusion criteria: 1, Patiens mental disorders are clearly involved in morbid obesity Background 2, Secondary obesity associated with endocrine disorders 3, Patients determined not to be expected the effect of weight loss surgery 4, Patients with severe renal dysfunction 5, Patients with severe liver failure 6, Pregnant women or women who may possibly be pregnant 7, Patients determined to be inappropriate as a test subject by investigators

Design outcomes

Primary

MeasureTime frame
To evaluate safety Confirm postoperative complications within 30 post operative days To evaluate efficacy HbA1c at 12months after surgery

Countries

Japan

Contacts

Public ContactHirofumi Imoto

Tohoku University Hospital Department of surgery

hirofumi-i@surg.med.tohoku.ac.jp022-717-7205

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026