A temporary loop ileostomy is widely used when operating rectal cancer. The ostomy is
then reversed in a separate operation. Morbidity of stoma reversal is significant, but
not clearly defined. One complication in connection with stoma closure is development of
hernia at the former stoma site.
A hernia is a weakening of the muscular layers and the connective tissue of the abdominal
wall, which may cause pain and discomfort, as well as an inconvenient bulge. A hernia
could also cause more serious complication of obstructed or strangulated bowel. According
to international studies, the incidence of hernia at the ostomy site varies between 7%
and 35%. Many of the studies are heterogenic and some of them include both colostomies
and ileostomies. Among studies that focus on reversal of ileotomies the hernia incidence
varies between 11-15%. Preliminary results from a retrospective study in Stockholm
indicates a frequency of 7,9%.
The best method to avoid hernia after stoma closure is not known. Most commonly surgeons
tend to close the fascia in one layer with monofilament suture. In the study mentioned
above 91% of the operations were done with one-layer monofilament, mostly PDS. Use of
prophylactic mesh in the abdominal wall has been proposed, but there is currently
insufficient scientific evidence to recommend it as a routine.
The present study is focused on loop ileostomy closure after rectal cancer. A
non-heterogenous group of ostomies will serve as a base to evaluate whether the incidence
of hernia may be reduced. If this study detects a decreased frequency of hernia when
using prophylactic meshes, it may lead to new recommendations for this patient group.
PHaLIR is a prospective, double-blinded randomized study in which patients planned for
stoma reversal after rectal cancer surgery will be randomized to retro muscular mesh
Ultrapro Advanced or standard treatment without mesh. Operating time, complications, LOS,
pain, infections and postoperative hernia are to be studied. The patients will be
identified and asked about participation when they come for postoperative control after
rectal cancer operation and are planned for the ileostomy reversal after check of the
rectal anastomosis. They will be given oral and written information and signed informed
consent is required from all patients.
At operation the operation-protocol should be filled in. The operation notes will be
written in a blinded way and the original version will be stored on paper until after the
study is finished and then added to the patient chart.
At discharge from the surgical ward the patient should be planned for a follow up at the
surgical clinic at 30 days postoperatively. The doctor at the follow up visit should be
another than the operating surgeon. The patients should then fill in a questionnaire and
the surgeon should note the postoperative complications in the 30-days follow up form. At
the 30-day follow up the surgeon checks that the one-year follow up after the cancer
operation is commissioned. Normally this is a CT thorax and abdomen with contrast. For
the study-patients it should be complemented with the question of hernia and the CT scan
shall be a CT with straining. The normal 1-year follow up for the cancer will be the
follow up for the ileostomy reversal also. That means that in most cases it will take
place 6-9 months after the reversal. At this control and at the three years control
(after cancer operation) the patient will be given or mailed a questionnaire (the same as
the 30-day questionnaire). The follow up by doctor could be done either with a clinical
visit or a telephone call according to the routines of the clinic when they follow up
their cancer patients. At three years follow up after cancer operation patients will also
get the same questionnaire and the CT scan follow up at three years will also be with
straining.
