The Effect of Compression Time for Secure Stapling With a Linear Stapler in Laparoscopic Gastric Bypass Surgery

NCT ID: NCT02069626

Last Updated: 2014-02-24

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

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Brief Summary

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Bleeding from the staple line is a complication of linear stapling. After clamping, a short period after firing of the laparoscopic linear stapler is recommended. That is, the clinician should continue to press the tissue between the prongs of the device to achieve adequate hemostasis at the staple line. The significance of the waiting period for hemostasis at the staple line has not been empirically clarified in humans. In this study, the investigators compared the number of bleeding points use of the laparoscopic linear stapler. Consequently, the investigators assessed the effects of time after the firing of linear stapling in patients who underwent laparoscopic gastric bypass.

Detailed Description

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Conditions

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Bleeding of the Staple Line

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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No wait

Usage of linear stapler without waiting of compression time

Group Type ACTIVE_COMPARATOR

compression time of the laparoscopic linear stapler

Intervention Type PROCEDURE

20 second wait

Usage of linear stapler with 20 second compression time

Group Type ACTIVE_COMPARATOR

compression time of the laparoscopic linear stapler

Intervention Type PROCEDURE

60 second wait

Usage of linear stapler with 60 second compression time

Group Type ACTIVE_COMPARATOR

compression time of the laparoscopic linear stapler

Intervention Type PROCEDURE

Interventions

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compression time of the laparoscopic linear stapler

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Clinical diagnosis of morbid obesity
* Must be laparoscopic surgery

Exclusion Criteria

* Usage of anti-coagulant
* Presence of impaired blood clotting
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Inonu University

OTHER

Sponsor Role lead

Responsible Party

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mehmet ali yagci

MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Turgut Özal medical center

Malatya, Malatya, Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Other Identifiers

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2013/214

Identifier Type: -

Identifier Source: org_study_id

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