Oversewing Staple Line of The Gastric Remnant

NCT04884230 | Completed

• 1 other identifier: UnidadInternacional
• Study Type: observational
• Target: 250
• Locations: 1 country
• Sites: 1

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.

Conditions

Gastric Bypass; Obesity

Keywords

Obesity

Outcome Measures

Primary Outcomes (1)

• Reduce bleeding

  assessing melena

  Through study completion, 6 month average

Study Arms (2)

Group A

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.

Procedure: Oversewing

Group B

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.

Interventions

Oversewing PROCEDURE

Oversewing of the gastric remnant

Group A

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Unidad Internacional de Cirugia Bariatrica y Metabolica: lead

Study Sites (1)

CCSF

Maracaibo, Zulia, Venezuela

Location

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Year
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr.

Study Record Dates

• First Submitted: May 3, 2021
• First Posted: May 12, 2021
• Study Start: February 5, 2017
• Primary Completion: February 5, 2020
• Study Completion: May 5, 2020
• Last Updated: May 12, 2021

Record last verified: 2021-05

Data Sharing

• IPD Sharing: Will not share

Locations

VE (1)