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Comparison between the effects of Roux-en-Y gastric bypass (traditional surgery) and mini-gastric bypass (new technique) as treatments of morbid obesity

Comparison between the effects of Roux-en-Y gastric bypass and one-anastomosis gastric bypass as treatments of morbid obesity: prospective randomized controlled trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
REBEC
Registry ID
RBR-59k78k
Enrollment
Unknown
Registered
2017-12-20
Start date
2017-05-01
Completion date
Unknown
Last updated
2025-10-27

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

Conditions

Obesity

Interventions

Group 1 - 25 individuals: Roux-en-Y gastric bypass: surgery characterized by the creation of a 40-ml gastric pouch along with a 250-cm intestinal bypass by means of 2 anastomosis Group 2 - 25 individu
Procedure/surgery
E02.065.062.249
E04.210

Sponsors

Universidade Estadual de Campinas
Lead Sponsor
Universidade Estadual de Campinas
Collaborator

Eligibility

Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: Morbidly obese individuals which are candidates for bariatric surgery according to the National Institutes of Health (NIH) and Brazilian Dept. of Health criteria; any gender; obese for at least 5 years; aged 18-70 years old; Body mass index >= 40 kg/m2; body mass index >= 35 kg/m2 with obesity-related co-morbidities (hypertension, dyslipidemia(s), diabetes mellitus, glucose intolerance, degenerative ostheoarthropathies and/or sleep apnea).

Exclusion criteria

Exclusion criteria: Loss to follow-up before completion of one-year follow-up; vulnerable groups; non-compensated psychiatric disorders; use of alcohol or illicit drugs; misunderstanding of the proposed protocol

Design outcomes

Primary

MeasureTime frame
Excess weight loss; Excess weight loss calculated according to the formula: %EWL = (initial weight - achieved weight)*100/(initial weight - ideal weight); it is expected to observe a percent excess weight loss > 80% after 12 months.—

Secondary

MeasureTime frame
Overall surgical morbidity; Overall surgical morbidity will be measured by the division of the number of individuals who presented complications by the total number of operated individuals; Expected overall surgical morbidity < 2%.—

Countries

Brazil

Contacts

Public ContactEverton Cazzo

Faculdade de Ciências Médicas - Universidade Estadual de Campinas

cazzo@unicamp.br+55-19-35219450

Outcome results

None listed

Source: REBEC (via WHO ICTRP)