To compare postoperative pain after anterior inguinal repair with mesh according to Lichtenstein or open repair with Polysoft® mesh
ID
Source
Brief title
Condition
- Soft tissue therapeutic procedures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Primary endpoint will be difference in pain and chronic pain postoperatively.
Secondary outcome
Secondary endpoints are length of operation, postoperative complications,
length of hospital stay, return to daily activities and work, costefficiency
analysis, health related quality of life and recurrence.
Background summary
Chronic pain is a postoperative complication in inguinal repair. Anterior open
approach with mesh is advocated by the Dutch Surgeon*s College. Preliminary
experience with a lightweight mesh placed in the preperitoneal space showed
good results and less postoperative pain.
Study objective
To compare postoperative pain after anterior inguinal repair with mesh
according to Lichtenstein or open repair with Polysoft® mesh
Study design
We aim to perform a double centre, double blind randomised controlled trial to
compare both methods.
Intervention
One group will be operated via an anterior approach with mesh placement
according to Lichtenstein, the other group will be operated via an anterior
approach with Polysoft® mesh placement in the preperitoneal space.
Study burden and risks
Patients will be asked to fill in questionnaires. Outpatient clinic check ups
will be scheduled at two weeks, three months and one year postoperatively.
Hilvarenbeekseweg 60
5022 GC Tilburg
Nederland
Hilvarenbeekseweg 60
5022 GC Tilburg
Nederland
Listed location countries
Age
Inclusion criteria
Primary groin hernia unilaterally, Age > 18 years. ASA classification 1-3, Signed informed consent letter
Exclusion criteria
Recurrent hernia, Age <18or >80, Scrotal hernia*s , ASA 4/5, Acute incarcerated inguinal hernias, Psychiatric disease or other reason making follow up of filling in questionnaires unreliable.
Design
Recruitment
Medical products/devices used
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 |
|---|---|
| CCMO | NL16781.008.07 |