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Mesh versus patch for hernia epigastrica and umbilical repair. A multicenter patient-blinded randomized trial.


- candidate number8456
- NTR NumberNTR2514
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR20-sep-2010
- Secondary IDsM10-1070 METC Catharina Hospital
- Public TitleMesh versus patch for hernia epigastrica and umbilical repair. A multicenter patient-blinded randomized trial.
- Scientific TitleMesh versus patch for hernia epigastrica and umbilical repair. A multicenter patient-blinded randomized trial.
- ACRONYMMORPHEUS
- hypothesisA ventral patch repair of umbilical and epigastric hernia is associated with less complications than a conventional mesh.
- Healt Condition(s) or Problem(s) studiedEpigastric hernia, Umbilical hernia
- Inclusion criteria1. Symptomatic single primary umbilical or epigastric hernia;
2. Size less than 3 cm (2 fingers).
- Exclusion criteria1. Age < 18 years;
2. Not capable to understand and complete questionnaires;
3. Presence of ascites.
- mec approval receivedyes
- multicenter trialyes
- randomisedyes
- masking/blindingSingle
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-jan-2011
- planned closingdate1-jul-2013
- Target number of participants346
- InterventionsRandomization between mesh placement between fascie and peritoneum (Method MESH) or below the peritoneum (Method PATCH).

The conventional procedure begins with a para-umbilical or median incision across the hernia. Dissection to fascie level and mobilising of the crack pocket. Opening for the means of inspection is permitted. Dissection of the preperitoneal area. Placement of a polypropylene mesh with a minimal diameter of 6 cm. Fixation of the mesh with insoluble monofilament stitches.

The patch procedure: Opening of the crack pocket. Possible adhesions must be freed intraperitoneal. Patch is placed against the peritoneum. Slips are fixed to the fascie. We have chosen the standard of a PROCEED tm VENTRAL PATCH (Ethicon, Norderstedt, Germany).
- Primary outcomeNumber of complications necessitating an intervention.
- Secondary outcome1. VDS pain score;
2. VDS cosmetic score;
3. Operation duration;
4. Costs.
- TimepointsPre-operative, month 1, 3, 12 and 24.
- Trial web sitehttp://www.morpheustrial.nl
- statusplanned
- CONTACT FOR PUBLIC QUERIES S.W. Nienhuijs
- CONTACT for SCIENTIFIC QUERIES S.W. Nienhuijs
- Sponsor/Initiator Catharina Hospital Eindhoven, Department of Surgery
- Funding
(Source(s) of Monetary or Material Support)
Catharina Hospital Eindhoven, Department of Surgery
- PublicationsN/A
- Brief summaryN/A
- Main changes (audit trail)
- RECORD20-sep-2010 - 2-sep-2011


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