Inguinal hernia management: operation or observation? A randomised controlled multicentre trial
| ISRCTN | ISRCTN31866667 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN31866667 |
| Protocol serial number | NTR221 |
| Sponsor | Erasmus Medical Centre (Netherlands) |
| Funder | The Netherlands Organisation for Health Research and Development (ZonMw) (The Netherlands) |
- Submission date
- 20/12/2005
- Registration date
- 20/12/2005
- Last edited
- 18/11/2008
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Digestive System
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Prof J. Jeekel
Scientific
Scientific
Erasmus Medical Centre
Department of General Surgery
Molewaterplein 40
Rotterdam
3015 GD
Netherlands
| Phone | +31 (0)10 463 3718 |
|---|---|
| j.jeekel@erasmusmc.nl |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Multicentre, randomised, active controlled, parallel group trial |
| Secondary study design | Randomised controlled trial |
| Scientific title | |
| Study objectives | Non-inferiority hypothesis: observation is not inferior to operation with respect to the mean of pain and discomfort during 3 years follow-up. |
| Ethics approval(s) | Received from the local medical ethics committee |
| Health condition(s) or problem(s) studied | Hernia Inguinal |
| Intervention | 1. Operation 2. No intervention, observational management of the inguinal hernia |
| Intervention type | Other |
| Primary outcome measure(s) |
The mean of 4 pain/discomfort scores during a follow-up period of 3 years. |
| Key secondary outcome measure(s) |
Quality adjusted life years (QALY) with quality weights measured with the EuroQol and in a sensitivity analysis with a transformed 36-item short form (SF-36) utility weight, medical and non-medical costs and event-free survival at 2 years. |
| Completion date | 01/01/2011 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Male |
| Target sample size at registration | 800 |
| Key inclusion criteria | 1. Unilateral inguinal hernia 2. Males 3. Medial or lateral inguinal hernia 4. Aged greater than or equal to 50 years 5. Description I or II of pain or discomfort interfering with daily activity 6. Primary or recurrent inguinal hernia 7. Informed consent (addendum V) |
| Key exclusion criteria | 1. Gender: female 2. Bilateral inguinal hernia 3. Femoral hernia 4. Description III or IV of pain or discomfort interfering with daily activity 5. Acute hernia complication (bowel obstruction, incarceration, strangulation, peritonitis or perforation) 6. Patient classified as American Society of Anaesthesiologist Class 4 7. Scrotal hernia (cannot be corrected laparoscopically) 8. Patient is unable to speak Dutch 9. Physical activity: patient travels regularly during which professional medical help is not always accessible 10. Inguinal hernia not apparent during ultrasonography |
| Date of first enrolment | 01/01/2006 |
| Date of final enrolment | 01/01/2011 |
Locations
Countries of recruitment
- Netherlands
Study participating centre
Erasmus Medical Centre
Rotterdam
3015 GD
Netherlands
3015 GD
Netherlands
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
