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

Bleeding of the Staple Line Clinical Trial

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02069626
• Other study ID #: 2013/214
• Status: Active, not recruiting
• Phase: N/A
• First received: February 18, 2014
• Last updated: February 21, 2014

Study information

• Verified date: February 2014
• Source: Inonu University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Turkey: Drug and Medical Device Institution
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 60
• Est. primary completion date: December 2014
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Clinical diagnosis of morbid obesity

• Must be laparoscopic surgery

Exclusion Criteria:

• Usage of anti-coagulant

• Presence of impaired blood clotting

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Bleeding of the Staple Line

Intervention

Procedure:
• compression time of the laparoscopic linear stapler

Locations

Country	Name	City	State
Turkey	Turgut Özal medical center	Malatya

Sponsors (1)

Lead Sponsor	Collaborator
Inonu University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of the bleeding points at the staple line		intraoperative