Prevention of incisional hernias with prophylactic synthetic mesh placement during stoma reversal

A recent meta-analyses showed that one in three patients develops an incisional
hernia following stoma closure. In addition, approximately fifty percent of
these patients require surgical correction. It is important to realize that
incisional hernias are a major cause of patient morbidity as they cause
abdominal pain, discomfort, impaired quality of life and an increase hospital
stay and the number of surgical interventions. According to recent
retrospective comparative studies, prophylactic mesh placement during stoma
closure could markedly decrease incisional hernia rate. However, the currently
available studies comparing standard stoma closure and mesh-reinforced stoma
closure mainly focused on ileostomy closure, included only a limited number of
patients and were all retrospective, therefore; strong evidence is lacking.

The aim of this study is therefore to prospectively investigate whether
prophylactic synthetic mesh placement reduces the rate of stomal site
incisional hernias after stoma closure without increasing (infectious)
complications.

Randomized controlled trial, single-blinded.

One group (standard arm) receives standard stoma closure and the other group
(intervention arm) will have a preventive synthetic mesh placed in addition to
standard stoma closure

Half of the patients included in the study (intervention arm) will have a
synthetic mesh placed in order to prevent incisional hernia development. These
meshes have been used in hernia repair for several decades and are regarded as
safe. However, in our study, the meshes are placed in possibly contaminated
area. Even though several studies have shown that synthetic mesh placement in a
mildly contaminated area can be safely performed when using the right surgical
techniques, this could in theory still lead to a slightly increased risk of
surgical site infection. In order to minimalize this risk several preventive
measures will be taken, such as per-operative administration of antibiotics,
avoidance of contact between incision site and mesh when placing it in the
abdomen and closure of the fascia with PDS (monofilament). In addition, the
patients will be asked to fill out quality of life questionnaires five times,
which will take approximately 20 minutes.
A possible advantage of participation for patients in the intervention arm
could be a lower incidence of incisional hernias. Hereby, patients could be
spared from the discomfort and other symptoms associated with incisional
hernias. In addition, fewer patients will have to undergo an additional
surgical intervention in order to repair an incisional hernia.