|- candidate number||6491|
|- NTR Number||NTR2018|
|- ISRCTN||ISRCTN wordt niet meer aangevraagd.|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||18-sep-2009|
|- Secondary IDs||NL22695.091.08/80-82305-98-09004 ABR/ZonMW|
|- Public Title||Prevention of a hernia next to a stoma with a prosthetic mesh.
|- Scientific Title||Prevention of parastomal hernia with a prosthetic mesh, a multicenter randomized controlled trial.|
|- ACRONYM||Prevent trial|
|- hypothesis||A lightweight monofilament polypropylene mesh in a sublay position reduces the incidence of a parastomal hernia.|
|- Healt Condition(s) or Problem(s) studied||Colorectal surgery, Parastomal hernia, Colostomy, Polyproylene mesh|
|- Inclusion criteria||1. Aanleg van een nieuw electief, in opzet definitief, eindstandig colostoma;|
2. >18 jaar en <80 jaar;
3. Informed consent is verkregen.
|- Exclusion criteria||1. Overleving korter dan 12 maanden is te verwachten of gemetastaseerde ziekte;|
2. Correctie van een eerder aangelegd stoma, tenzij een nieuwe wordt gecreëerd;
3. Geen “maagdelijke buikwand” op de stoma plaats;
4. Belangrijke taalbarričre.
|- mec approval received||yes|
|- multicenter trial||yes|
|- control||Not applicable|
|- Type||2 or more arms, randomized|
|- planned startdate ||1-okt-2009|
|- planned closingdate||1-okt-2014|
|- Target number of participants||150|
|- Interventions||A lightweight monofilament polypropylene mesh placed in a sublay position is compared with formation of an end-colostomy without a mesh.|
|- Primary outcome||The incidence of parastomal hernia.|
|- Secondary outcome||Cost effectiveness analysis, quality of life and pain scores.|
|- Timepoints||3 weeks, 3 months, 1 year, 2 years and 5 years.|
|- Trial web site||www.preventtrial.nl|
|- CONTACT FOR PUBLIC QUERIES||Drs. H.T. Brandsma|
|- CONTACT for SCIENTIFIC QUERIES||Drs. H.T. Brandsma|
|- Sponsor/Initiator ||Canisius Wilhelmina Hospital, ZonMw: The Netherlands Organization for Health Research and Development|
(Source(s) of Monetary or Material Support)
|ZON-MW, The Netherlands Organization for Health Research and Development, Covidien Nederland|
|- Brief summary||Prevention of parastomal hernia with a prosthetic mesh, a multicenter randomized controlled trial.|
Aim: Does the use of a monofilament polypropylene mesh in a sublay position during the creation of a colostomy reduce the incidence of parastomale hernia?
Introduction: Treatment of a parastomal hernia remains a difficult problem. One trial (54 patients) demonstrated a beneficial effect of prophylactic placement of a mesh during the formation of a colostomy. But in this trial the follow-up was relatively short and it was prematurely stopped. Until now
the use of a prophylactic mesh is not a standard treatment (in the Netherlands).
Methods: Prospective randomised (single blind) multicentre trial.
Population: Patients with an elective suspected permanent colostomy between the age of 18 and 80 will be asked
to participate unless there is a life expectancy of less than 12 months.
Intervention: A lightweight partially absorbable monofilament polypropylene mesh placed in a sublay
positions as described by Israelsson is compared with a colostomy without a mesh.
Endpoint: The incidence of parastomal hernia with a follow-up after 3 weeks, 3 months, 1, 2 and 5 years.
endpoints: cost effectiveness analysis, quality of life and pain scores.
Sample size: A reduction from 30% (non mesh) towards 10% (mesh group) parastomale hernia is expected.
Based on a p-value of 0.05 (alfa), a power of 90% (beta) and a two-sided test 134 patients areneeded. A total of 150 patients will be included with 75 patients in each trial arm
Inclusion time: 11 academic and training hospitals will participate in the inclusion. The inclusion should
be completed after 18 months. The first data analysis and first report will be after one year follow-up as
generally accepted in hernia research but follow-up will be completed after five years.
|- Main changes (audit trail)|
|- RECORD||18-sep-2009 - 29-okt-2009|