Reduce postoperative chronic pain after open inguinal hernia repair.
ID
Source
Brief title
Condition
- Other condition
- Connective tissue disorders (excl congenital)
- Soft tissue therapeutic procedures
Synonym
Health condition
liesbreuk herstel
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Postoperative chronic pain
Secondary outcome
Health status; recurrence; cost analysis; serious adverse events
Background summary
Optimal open preperitoneal inguinal hernia repair.
The current main problem after Lichtenstein (gold standard) is postoperative
chronic pain.
TIPP has proven (in the TULIP trial) to reduce postoperative chronic pain
compared to Lichtenstein, therefore we use TIPP as control itnervention in this
trial.
A new technique has been developed: transrectus sheath preperitoneal mesh
repair (TREPP), in which via open approach a polysoft mesh is positioned in the
preperitoneal space. Results of the first 1000 patients show a low recurrence
rate, comparable to Lichtenstein; and few patients with postoperative chronic
pain.
This trial will compare TREPP with TIPP, in a randomized trial.
Study objective
Reduce postoperative chronic pain after open inguinal hernia repair.
Study design
RCT, multi center.
Randomisation: TREPP of TIPP.
Questionnaires with every follow up at outpatient department.
Intervention
TREPP or TIPP; both open preperitoneal mesh repair for inguinal hernia.
TIPP: via inguinal canal mesh positioning in the preperitoneal space
TREPP: via anterior rectus sheath mesh positioning in the preperitoneal space.
Study burden and risks
No other risk than normal operation risk.
Burden consists of 2 extra outpatient clinic visits.
Geert Grooteplein 10
Nijmegen 6525GA
NL
Geert Grooteplein 10
Nijmegen 6525GA
NL
Listed location countries
Age
Inclusion criteria
*primary, groin hernia, unilateral
*age >18 years and < 80 years
*ASA classification 1-3
*signed informed consent
Exclusion criteria
*recurrences
*scrotal hernia
*femoral hernia
*bilateral hernia
*ASA >3
*incarcerated hernia
*psychiatric disease
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 |
|---|---|
| Other | ISRTCN18591339 |
| CCMO | NL38842.091.12 |