Stapled vs Hand Sewn Anastomosis in Roux en Y Gastric Bypass for Morbid Obesity: Randomized Clinical Trial (STAVHAS)

Virgen de la Arrixaca University Clinical Hospital (HCUVA)

Status and phase: Unknown; Phase 3

Conditions: Morbid Obesity

Treatments: Procedure: Roux en Y Gastric Bypass

Study type: Interventional

Funder types: Other

Identifiers

NCT02077517

OBES-001

Details and patient eligibility

About

The purpose of this study is to compare postoperative complications between hand sewn and stapled anastomosis after performing Roux en Y-Gastric Bypass as a treatment for morbid obesity.

Enrollment: 400 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• patients over 18 years
• absence of previous bariatric surgery

Exclusion criteria

• less than 18 years old
• coagulation disorders or liver cirrhosis

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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400 participants in 2 patient groups

hand sewn anastomosis

Active Comparator group

Description:

Patients with hand sewn anastomosis during Roux en Y Gastric bypass performing

Treatment:

Procedure: Roux en Y Gastric Bypass

stapled anastomosis

Active Comparator group

Description:

Patients with stapled anastomosis during Roux en Y Gastric Bypass performing

Treatment:

Procedure: Roux en Y Gastric Bypass