Oversewing Staple Line of The Gastric Remnant

Completed

• Conditions: Obesity; Gastric Bypass
• Interventions: Procedure: Oversewing

• Registration Number: NCT04884230
• Lead Sponsor: Unidad Internacional de Cirugia Bariatrica y Metabolica

Brief 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.

Study Timeline

• Study Start: 2017-02-05
• Primary Completion: 2020-02-05
• Study Completion: 2020-05-05
• Status Verified: 2021-05
• Study First Submitted: 2021-05-03
• Study First Submitted QC: 2021-05-06
• Last Update Submitted: 2021-05-06
• Study First Posted: 2021-05-12
• Last Update Posted: 2021-05-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 250

Inclusion Criteria

• Our inclusion criteria were patients older than 18 years, body mass index (BMI) > 30kg/m2 with or without comorbidities that underwent RYGB or one anastomosis gastric bypass (OAGB).

Exclusion Criteria

• We exclude from our study any patient with psychiatric disorder, open surgery history, history of previous bariatric surgery, non-controlled comorbidity at the moment of surgery, and patients under the age of 18

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Group A	Oversewing	We 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.

Primary Outcome Measures

Name	Time	Method
Reduce bleeding	Through study completion, 6 month average	assessing melena

Trial Locations

Locations (1)

CCSF; 🇻🇪 MAracaibo, Zulia, Venezuela