Suture Techniques to Reduce the Incidence of The inCisional Hernia (STITCH)

Erasmus University

Status: Completed

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

Treatments: Procedure: Closure of the abdominal wall after midline incisions

Study type: Interventional

Funder types: Other

Identifiers

NCT01132209

STITCH trial MEC 2009-026

Details and patient eligibility

About

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.

Enrollment: 576 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion criteria

• Signed informed consent
• All laparotomies with a midline incision
• Age > 18 years

Exclusion criteria

• Previous incisional hernia after midline incision
• Previous surgery through a midline incision within 3 months
• Pregnancy (in women)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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576 participants in 2 patient groups

Large tissue bites

Active Comparator group

Description:

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.

Treatment:

Procedure: Closure of the abdominal wall after midline incisions

small tissue bites

Experimental group

Description:

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.

Treatment:

Procedure: Closure of the abdominal wall after midline incisions