No registrations found.
ID
Source
Brief title
Health condition
Epigastric and umbilical hernia
Sponsors and support
The Netherlands
Intervention
Outcome measures
Primary outcome
Number of complications necessitating an intervention.
Secondary outcome
1. VDS pain score;
2. VDS cosmetic score;
3. Operation duration;
4. Costs.
Background summary
N/A
Study objective
A ventral patch repair of umbilical and epigastric hernia is associated with less complications than a conventional mesh.
Study design
Pre-operative, month 1, 3, 12 and 24.
Intervention
Randomization 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).
S.W. Nienhuijs
Catharina Hospital, dpt of Surgery
Eindhoven 5623 EJ
The Netherlands
simon.nienhuijs@cze.nl
S.W. Nienhuijs
Catharina Hospital, dpt of Surgery
Eindhoven 5623 EJ
The Netherlands
simon.nienhuijs@cze.nl
Inclusion criteria
1. Symptomatic single primary umbilical or epigastric hernia;
2. Size less than 3 cm (2 fingers).
Exclusion criteria
1. Age < 18 years;
2. Not capable to understand and complete questionnaires;
3. Presence of ascites.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL2406 |
| NTR-old | NTR2514 |
| Other | METC Catharina Hospital : M10-1070 |
| ISRCTN | ISRCTN wordt niet meer aangevraagd. |