The Effect of Compression Time for Secure Stapling With a Linear Stapler in Laparoscopic Gastric Bypass Surgery
February 21, 2014 updated by: mehmet ali yagci, Inonu University
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.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
60
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Malatya, Turkey, 44000
- Turgut Ozal Medical Center
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
N/A
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Clinical diagnosis of morbid obesity
- Must be laparoscopic surgery
Exclusion Criteria:
- Usage of anti-coagulant
- Presence of impaired blood clotting
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: No wait
Usage of linear stapler without waiting of compression time
|
|
|
Active Comparator: 20 second wait
Usage of linear stapler with 20 second compression time
|
|
|
Active Comparator: 60 second wait
Usage of linear stapler with 60 second compression time
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Number of the bleeding points at the staple line
Time Frame: intraoperative
|
intraoperative
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Primary Completion (Anticipated)
December 1, 2014
Study Registration Dates
First Submitted
February 18, 2014
First Submitted That Met QC Criteria
February 21, 2014
First Posted (Estimate)
February 24, 2014
Study Record Updates
Last Update Posted (Estimate)
February 24, 2014
Last Update Submitted That Met QC Criteria
February 21, 2014
Last Verified
February 1, 2014
More Information
Terms related to this study
Other Study ID Numbers
- 2013/214
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.