Suture Techniques to Reduce the Incidence of The inCisional Hernia

Not Applicable

Completed

• Conditions: Quality of Life; Wound Infection; Burst Abdomen; Pain; Hernia

• Registration Number: NCT01132209
• Lead Sponsor: Erasmus Medical Center

Brief Summary

The objective of the study is reduction of the incidence of the most frequent complication of abdominal surgery, incisional hernia. In this multi center double-blinded prospective randomized controlled trial, in which a new suture technique using small bites is compared with the traditionally applied large bites (mass closure) technique for midline incisions.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-10
• Study First Submitted: 2010-05-26
• Study First Submitted QC: 2010-05-26
• Study First Posted: 2010-05-27
• Primary Completion: 2013-04
• Study Completion: 2013-05
• Status Verified: 2014-07
• Last Update Submitted: 2014-07-31
• Last Update Posted: 2014-08-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 576

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Incisional hernia occurrence within one year after operation clinical and/or radiographically detected	one year

Secondary Outcome Measures

Name	Time	Method
postoperative complications; in particular wound infection (during admission), burst abdomen (during admission) and wound pain (measured with a visual analog scale (VAS) during the first 6 days after surgery).	one month

Trial Locations

Locations (1)

Erasmus Medical Center; 🇳🇱 Rotterdam, Zuid-Holland, Netherlands