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Sleeve Versus Bypass in Older Patients: a Randomized Controlled Trial

NCT03339791 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 36

Last updated 2020-12-02

No results posted yet for this study

Summary

The aim of the study is to compare two different bariatric procedures performed in patients with 65 years or more: gastric bypass and sleeve gastrectomy. Primary outcomes will be weight loss, control of comorbidities and morbidity of the operation. Secondary outcomes are related to functionality, that will be evaluated with specific tests.

Conditions

  • Obesity, Morbid
  • Surgery
  • Elderly

Interventions

PROCEDURE

Sleeve Gastrectomy

Laparoscopic Sleeve Gastrectomy. Technique: complete mobilization of the greater curvature and gastric fundus up to the angle of Hiss; stapling beginning at 3 to 4 cm away from the pylorus; bougie size 32 French; oversuture of the staple line; hiatoplasty in selected cases; routine drainage of the abdominal cavity

PROCEDURE

Gastric Bypass

Laparoscopic Gastric Bypass. Technique: Pouch size 30 to 40 ml, biliopancreatic limb 70 to 100 cm, alimentary limb 100 to 120 cm, antecolic, routine closure of the mesenterial defects, routine drainage of the abdominal cavity

Sponsors & Collaborators

  • University of Sao Paulo General Hospital

    lead OTHER

Principal Investigators

  • Denis Pajecki · Hospital das Clinicas - Faculdade de Medicina da USP

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
65 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-09-23
Primary Completion
2017-11-07
Completion
2019-07-16

Countries

  • Brazil

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 NCT03339791 on ClinicalTrials.gov