Staple Line Inversion vs Buttressing on Postoperative Vomits After LSG

NCT ID: NCT03104023

Last Updated: 2017-06-27

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

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-01-31

Study Completion Date

2017-08-31

Brief Summary

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Patients undergoing laparoscopic sleeve gastrectomy will be randomized into 2 groups. In one group, a staple line inversion with a running suture of Polypropylene will be performed. In the second group, the gastric section will be performed with a stapler with preloaded buttress material

Postoperative nausea and vomits during the first 24 hours will be investigated.

Detailed Description

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Patients undergoing laparoscopic sleeve gastrectomy as bariatric procedure will be randomized into 2 groups. In one group after the stapling and section of the stomach with stapling devices (EndoGIA, Covidien, USA), a staple line inversion with hemostatic and aims will be performed. Staple line inversion will be performed with a running suture of Polypropylene 2/0. In the second group, the gastric section will be performed with a stapler with preloaded buttress material (EndoGIA with reinforced reload, Covidien, USA).

Postoperative nausea and vomits during the first 24 hours after surgery will be investigated.

Conditions

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Vomiting, Postoperative

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Staple line inversion

Patients will undergo a staple line inversion with a a running suture of Polypropylene 2/0.

Group Type ACTIVE_COMPARATOR

Staple line inversion

Intervention Type PROCEDURE

A staple line inversion will be performed with a running suture of Polypropylene 2/0

Staple line buttressing

The gastric section will be performed with preloaded buttress material .

Group Type EXPERIMENTAL

Staple line buttressing

Intervention Type COMBINATION_PRODUCT

The gastric section will be performed with a stapler with preloaded buttress material

Interventions

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Staple line inversion

A staple line inversion will be performed with a running suture of Polypropylene 2/0

Intervention Type PROCEDURE

Staple line buttressing

The gastric section will be performed with a stapler with preloaded buttress material

Intervention Type COMBINATION_PRODUCT

Eligibility Criteria

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Inclusion Criteria

* BMI \>40
* BMI\>35 with obesity-related comorbidities

Exclusion Criteria

* Patients undergoing other bariatric techniques than sleeve gastrectomy
* Laparotomic approach
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hospital General Universitario Elche

OTHER

Sponsor Role lead

Responsible Party

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Jaime Ruiz-Tovar, MD, PhD

Head of Bariatric Surgery Unit. Hospital general Elche

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jaime Ruiz-Tovar

Role: PRINCIPAL_INVESTIGATOR

Hospital general Elche

Locations

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Hospital general Universitario de Elche

Elche, Alicante, Spain

Site Status RECRUITING

Countries

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Spain

Central Contacts

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Lorea Zubiaga, MD, PhD

Role: CONTACT

Maria Diez, MD, PhD

Role: CONTACT

Facility Contacts

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Jaime Ruiz-Tovar, MD, PhD

Role: primary

0034-630534808

Other Identifiers

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HGUE 2016-33

Identifier Type: -

Identifier Source: org_study_id

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