Stapled vs Hand Sewn Anastomosis in Roux en Y Gastric Bypass for Morbid Obesity: Randomized Clinical Trial

NCT ID: NCT02077517

Last Updated: 2014-03-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

400 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-01-31

Brief Summary

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The purpose of this study is to compare postoperative complications between hand sewn and stapled anastomosis after performing Roux en Y-Gastric Bypass as a treatment for morbid obesity.

Detailed Description

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Conditions

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Morbid Obesity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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hand sewn anastomosis

Patients with hand sewn anastomosis during Roux en Y Gastric bypass performing

Group Type ACTIVE_COMPARATOR

Roux en Y Gastric Bypass

Intervention Type PROCEDURE

stapled anastomosis

Patients with stapled anastomosis during Roux en Y Gastric Bypass performing

Group Type ACTIVE_COMPARATOR

Roux en Y Gastric Bypass

Intervention Type PROCEDURE

Interventions

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Roux en Y Gastric Bypass

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* patients over 18 years
* absence of previous bariatric surgery

Exclusion Criteria

* less than 18 years old
* coagulation disorders or liver cirrhosis
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hospital Universitario Virgen de la Arrixaca

OTHER

Sponsor Role lead

Responsible Party

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Israel Abellan Morcillo

Bariatric Surgery unit

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Hospital Clinico Universitario Virgen de la Arrixaca

El Palmar, Murcia, Spain

Site Status RECRUITING

Countries

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Spain

Facility Contacts

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Israel Abellan, Ph

Role: primary

615217706

Other Identifiers

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OBES-001

Identifier Type: -

Identifier Source: org_study_id

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