Clinical Trial Details
— Status: Recruiting
Administrative data
| NCT number |
NCT03720262 |
| Other study ID # |
PHaLIR |
| Secondary ID |
|
| Status |
Recruiting |
| Phase |
Phase 2/Phase 3
|
| First received |
|
| Last updated |
|
| Start date |
March 1, 2018 |
| Est. completion date |
December 31, 2029 |
Study information
| Verified date |
March 2024 |
| Source |
Karolinska Institutet |
| Contact |
Åsa Hallqvist Everhov, MD, PhD |
| Phone |
+46702264127 |
| Email |
asa.hallqvist-everhov[@]sll.se |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
PHaLIR is a prospective, double-blinded randomized study in which patients planned for stoma
reversal after rectal cancer surgery are randomized between retro muscular mesh Ultrapro
Advanced or standard treatment without mesh.
Description:
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.
