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Oversewing Staple Line of The Gastric Remnant

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04884230
Enrollment
250
Registered
2021-05-12
Start date
2017-02-05
Completion date
2020-05-05
Last updated
2021-05-12

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

Conditions

Gastric Bypass, Obesity

Keywords

Obesity

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.

Interventions

PROCEDUREOversewing

Oversewing of the gastric remnant

Sponsors

Unidad Internacional de Cirugia Bariatrica y Metabolica
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Reduce bleedingThrough study completion, 6 month averageassessing melena

Countries

Venezuela

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026