Oversewing Staple Line of The Gastric Remnant

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Gastric Bypass, Obesity

Intervention / Treatment
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* Procedure: Oversewing


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Group A<br>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<br>* Oversewing of the gastric remnant<br>|
| Group B<br>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. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reduce bleeding | assessing melena | Through study completion, 6 month average | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Obesity