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

Rationale:

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.



Objective:

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



Study design:

Multicentre randomized controlled trial, single-blinded.



Study population:

All patients that undergo stoma closure at Meander Medical Center and Jeroen Bosch Hospital.

Intervention (if applicable):

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.

Main study parameters/endpoints:

Incisional hernia rate as detected by CT or abdominal ultrasound 1 year following stoma closure

Nature and extent of the burden and risks associated with participation, benefit and group relatedness:

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. This could, in theory, lead to a slight increase in surgical site infection risk. 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 suture).

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.

Prophylactic synthetic mesh placement during stoma reversal reduces the rate of stomal site incisional hernias without increasing (infectious) complication rate.

- Incisional hernia, both clinically and radiologically will be registered at 12 months.

- Questionnaires will be filled in at 0, 3, 6, 9, and 12 months.

- Morbidity, mortality, read-mission and re-operation rate will be registered at 30-days

Control group: standard stoma closure

- Closure of fascia

- Peroperative AB prophylaxis (1 dose)

Intervention group: stoma closure + placement of an prophylactic synthetic mesh

- Closure of posterior fascia

- Placement of synthetic mesh

- Closure of anterior fascia

- Skin closure using purse string technique

- Per-operative AB prophylaxis (3 doses)