Suture Techniques to Reduce the Incidence of The inCisional Hernia

Erasmus Medical Center576 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

576

Conditions

Hernia Wound Infection Burst Abdomen Pain Quality of Life

Interventions

Closure of the abdominal wall after midline incisionsPROCEDURE

Closure of the midline incision after any abdominal operation. Suturing of the fascia of the abdominal wall with two different techniques

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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)

Locations (1)

Erasmus Medical Center

Rotterdam, South Holland, Netherlands

Outcomes

Primary Outcomes

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

Time frame: one year

Secondary Outcomes

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).

Time frame: one month

Data from ClinicalTrials.gov

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