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

Inonu University

Status: Unknown

Conditions: Bleeding of the Staple Line

Treatments: Procedure: compression time of the laparoscopic linear stapler

Study type: Interventional

Funder types: Other

Identifiers

NCT02069626

2013/214

Details and patient eligibility

About

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.

Enrollment: 60 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Clinical diagnosis of morbid obesity
• Must be laparoscopic surgery

Exclusion criteria

• Usage of anti-coagulant
• Presence of impaired blood clotting

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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60 participants in 3 patient groups

No wait

Active Comparator group

Description:

Usage of linear stapler without waiting of compression time

Treatment:

Procedure: compression time of the laparoscopic linear stapler

20 second wait

Active Comparator group

Description:

Usage of linear stapler with 20 second compression time

Treatment:

Procedure: compression time of the laparoscopic linear stapler

60 second wait

Active Comparator group

Description:

Usage of linear stapler with 60 second compression time

Treatment:

Procedure: compression time of the laparoscopic linear stapler