Prevent Trial;Prevention of parastomal hernia during construction of a colostomy by reinforcing the bowel wall with a polypropylene mesh. ;A multicentre randomized controlled trial.

A parastomal hernia is a hernia cicatricalis at a stoma site. The incidence
varies between 5-50% depending on type of the stoma and follow up methods.
Many surgical techniques have been tried to reduce the incidence of a
parastomal hernia. Of which the stoma type (ileostomy) and the stoma site
(through the rectus muscle) made an improvement, none the less the problem
occurs frequently.
The treatment of a parastomal hernia is a difficult problem. Various surgical
techniques have been described but the recurrence rate remains considerable
(16-40%). For this reason it seems promising to focus on the possible
prevention of a parastomal hernia in stead of treatment when one occurs.
There is one randomised, unfortunately prematurely stopped trial of Israelsson,
which demonstrates the usefulness of a preventive polypropylene mesh (Vypro,
Lightweigth multi&monofilament mesh, Ethicon) in the prevention of a parastomal
hernia.
Up until now the use of preventive mesh placement during the creation of a
colostomy is not standard practice in the Netherlands. This clears the way for
a prospective trial with using a mesh which has proven itself in the treatment
of hernias but now to prevent parastomal hernias.

Patients in whom a permanent (end) colostomy is created in (semi) elective
setting are randomised between the placement of a polypropylene mesh during
stoma creation and the classic method without a mesh.
Primary aim: Does the use of a lightweight monofilament polypropylene mesh
prevent the occurrence of a parastomal hernia? Asuming an reduction in
incidence from 30% in the classic group til 10% in the mesh arm. What are the
risks caused by using this mesh for this indication?
Secondary aim: Outway the costs and potential complicaties of a prophylactic
lightweigt polypropylene mesh the cost of treatment of a symptomatic parastomal
hernia? A cost effectiveness analysis.
What is the influence of a stoma and a possible parastomal hernia on the
quality of life and painscores?

The study is a prospective singleblind (patient) randomised multicentre trial.
The patients are eligible after applying the in- and exclusion criteria which
will be displayed in the next chapter. The eligible patients will be asked to
participate in the trial and will be informed about the pro and con*s of the
study before they are asked to sign the informed consent form.
When a patients agrees to participate in the trial he/she will be randomised
between the creation of a colostomy with or without the placement of a mesh
(ultrapro).
Postoperatively the short and long term complications will be documented
together with the painsscores and quality of life (SF-36).

To reduce the chance of complications caused by the preventive mesh placement a
lightweight partially absorbable monofilament mesh is chosen, Ultrapro
(Ethicon, 70 euro). The structure of the mesh allows cutting without losing its
integrity. The chance of an infection and fistulation is probably even smaller
in these types of mesh compared to a traditional mesh. This mesh is currenty
used to correct various types of abdominal wall hernia.

After the operation routine follow up will be performed based on the initial
diagnosis. This can be combined with follow up for this trial which is
scheduled at 1, 2 and 5 years after surgery. This follow up is aimed at the
stoma site and each time the patient will be asked to fill in a questionnaire
about quality of life and a pain score. If complications occur during (routine)
follow-up they will be treated as always.