Suture Techniques to Reduce the Incidence of The inCisional Hernia

Not Applicable

Completed

• Conditions: Quality of Life; Wound Infection; Burst Abdomen; Pain; Hernia
• Interventions: Procedure: Closure of the abdominal wall after midline incisions

• 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

Arm && Interventions

Group	Intervention	Description
small tissue bites	Closure of the abdominal wall after midline incisions	In the other group of 288 patients the small bites technique will be applied with bite widths of 0,5 cm and inter suture spacing of 0,5 cm with the use of PDS plus ll 2-0 single suture material with a 31 mm needle placed in the linea alba. In the small bites technique, twice as many stitches will be placed per sutured cm, with a smaller needle and thinner suture material.
Large tissue bites	Closure of the abdominal wall after midline incisions	As control the conventional large bites technique (mass closure) will be applied in with bites widths of 1 cm and inter-suture spacing of 1 cm with the use of PDS plus ll 1-0 double loop suture material with a 48 mm needle.

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