Pain after kugel versus lichtenstein repair: a randomised trial
| ISRCTN | ISRCTN47267588 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN47267588 |
| Secondary identifying numbers | NL779, NTR790 |
- Submission date
- 28/12/2006
- Registration date
- 28/12/2006
- Last edited
- 14/01/2021
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Digestive System
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr S Nienhuijs
Scientific
Scientific
Canisius-Wilhelmina Hospital
P.O. Box 9015
Nijmegen
6500 GS
Netherlands
| Phone | +31 (0)24 365 7657 |
|---|---|
| s.nienhuijs@hccnet.nl |
Study information
| Study design | Randomised, controlled, parallel group, single blinded trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Scientific title | Pain after kugel versus lichtenstein repair: a randomised trial |
| Study objectives | The open pre-peritoneal approach in inguinal hernia repair might have the benefit of a mesh in the preferred space without the disadvantages of an endoscopic procedure. |
| Ethics approval(s) | Approval received by the local ethics board (CMO Regio Arnhem-Nijmegen), on the 22-12-2003 (ref: JvG/CMO 0301). |
| Health condition(s) or problem(s) studied | Pain, Inguinal hernia |
| Intervention | The Lichtenstein procedure and the Kugel procedure for inguinal hernias. |
| Intervention type | Other |
| Primary outcome measure | Visual Analogue Sccale (VAS) pain score at three months postoperatively. |
| Secondary outcome measures | 1. VAS pain scores and consumed analgesics during the first two weeks postoperatively 2. Pain Disability Index scores 3. Neurological disturbances |
| Overall study start date | 01/12/2004 |
| Completion date | 01/10/2005 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Not Specified |
| Target number of participants | 172 |
| Total final enrolment | 172 |
| Key inclusion criteria | Adult patients who had been referred for elective primary, unilateral inguinal hernia repair and gave informed consent. |
| Key exclusion criteria | An irreducible inguinoscrotal hernia or previous procedures using the preperitoneal approach |
| Date of first enrolment | 01/12/2004 |
| Date of final enrolment | 01/10/2005 |
Locations
Countries of recruitment
- Netherlands
Study participating centre
Canisius-Wilhelmina Hospital
Nijmegen
6500 GS
Netherlands
6500 GS
Netherlands
Sponsor information
Canisius Wilhelmina Hospital (The Netherlands)
Hospital/treatment centre
Hospital/treatment centre
Postbus 9015
Nijmegen
6500 GS
Netherlands
| Website | http://www.cwz.nl/ |
|---|---|
"ROR" |
https://ror.org/027vts844 |
Funders
Funder type
Hospital/treatment centre
Canisius-Wilhelmina Hospital (The Netherlands)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/09/2007 | 14/01/2021 | Yes | No |
Editorial Notes
14/01/2021: The following changes have been made:
1. Publication reference added.
2. The final enrolment number has been added from the reference.
3. The NTR numbers have been added.
