NCT04884230

Oversewing Staple Line of The Gastric Remnant

Oversewing Staple Line of the Gastric Remnant in Gastric Bypass Reduces Postoperative Bleeding.

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 250 (actual)
• Sponsor: Unidad Internacional de Cirugia Bariatrica y Metabolica · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

Background: Roux-en-Y gastric bypass (RYGB) is a surgery with low rate complications. However, it is not exempt from them, and 1-6% suffer complications such as postoperative bleeding. Many intraoperative techniques have been evaluated to reduce postoperative bleeding, like the oversewing or reinforcement of the staple line. This study aims to evaluate the rate of postoperative bleeding in the oversewing of the staple line of the gastric remnant group versus the stapling only group. Methods: This is a 2-center, case-control study. The investigators randomly selected two groups who underwent RYGB or OAGB: group A (n=225) with oversewing from 2019-2020 and group B (n=225) with stapling only between the period of 2017-2018; both groups with similar demographic characteristics.

Detailed description

This case-control study was conducted in the International Unit of Bariatric and Metabolic Surgery of "Clinica La Sagrada Familia" located in Maracaibo, Venezuela, and in "Grupo Medico Santa Paula" Caracas, Venezuela. All procedures were performed by a single experienced bariatric surgeon during the period 2017-2020. The Ethics committees of Clinica "La Sagrada Familia" and "Grupo Medico Santa Paula" approved this study. The investigators selected 225 patients (group A) from the period 2019-2020 where the stapling line of the gastric remnant was oversewn and another group of 225 patients (group B) from the period of 2017-2018 with stapling alone.

Conditions

• Gastric Bypass
• Obesity

Interventions

Type	Name	Description
PROCEDURE	Oversewing	Oversewing of the gastric remnant

Timeline

• Start date: 2017-02-05
• Primary completion: 2020-02-05
• Completion: 2020-05-05
• First posted: 2021-05-12
• Last updated: 2021-05-12

Locations

1 site across 1 country: Venezuela