Overview

This trial is active, not recruiting.

Condition bleeding of the staple line
Treatment compression time of the laparoscopic linear stapler
Sponsor Inonu University
End date December 2014
Trial size 60 participants
Trial identifier NCT02069626, 2013/214

Summary

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose prevention
Arm
(Active Comparator)
Usage of linear stapler without waiting of compression time
compression time of the laparoscopic linear stapler
(Active Comparator)
Usage of linear stapler with 20 second compression time
compression time of the laparoscopic linear stapler
(Active Comparator)
Usage of linear stapler with 60 second compression time
compression time of the laparoscopic linear stapler

Primary Outcomes

Measure
Number of the bleeding points at the staple line
time frame: intraoperative

Eligibility Criteria

Male or female participants from 18 years up to 65 years old.

Inclusion Criteria: - Clinical diagnosis of morbid obesity - Must be laparoscopic surgery Exclusion Criteria: - Usage of anti-coagulant - Presence of impaired blood clotting

Trial information was received from ClinicalTrials.gov and was last updated in February 2014.
Information provided to ClinicalTrials.gov by Inonu University.