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Prevention of a hernia next to a stoma with a prosthetic mesh.


- candidate number6491
- NTR NumberNTR2018
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR18-sep-2009
- Secondary IDsNL22695.091.08/80-82305-98-09004 ABR/ZonMW
- Public TitlePrevention of a hernia next to a stoma with a prosthetic mesh.
- Scientific TitlePrevention of parastomal hernia with a prosthetic mesh, a multicenter randomized controlled trial.
- ACRONYMPrevent trial
- hypothesisA lightweight monofilament polypropylene mesh in a sublay position reduces the incidence of a parastomal hernia.
- Healt Condition(s) or Problem(s) studiedColorectal surgery, Parastomal hernia, Colostomy, Polyproylene mesh
- Inclusion criteria1. Aanleg van een nieuw electief, in opzet definitief, eindstandig colostoma;
2. >18 jaar en <80 jaar;
3. Informed consent is verkregen.
- Exclusion criteria1. 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 receivedyes
- multicenter trialyes
- randomisedyes
- masking/blindingSingle
- controlNot applicable
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-okt-2009
- planned closingdate1-okt-2014
- Target number of participants150
- InterventionsA lightweight monofilament polypropylene mesh placed in a sublay position is compared with formation of an end-colostomy without a mesh.
- Primary outcomeThe incidence of parastomal hernia.
- Secondary outcomeCost effectiveness analysis, quality of life and pain scores.
- Timepoints3 weeks, 3 months, 1 year, 2 years and 5 years.
- Trial web sitewww.preventtrial.nl
- statusplanned
- CONTACT FOR PUBLIC QUERIESDrs. H.T. Brandsma
- CONTACT for SCIENTIFIC QUERIESDrs. H.T. Brandsma
- Sponsor/Initiator Canisius Wilhelmina Hospital, ZonMw: The Netherlands Organization for Health Research and Development
- Funding
(Source(s) of Monetary or Material Support)
ZON-MW, The Netherlands Organization for Health Research and Development, Covidien Nederland
- PublicationsN/A
- Brief summaryPrevention 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.
Secondary 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)
- RECORD18-sep-2009 - 29-okt-2009


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