Randomised controlled trial of laparoscopic versus open repair of inguinal hernia
| ISRCTN | ISRCTN64721841 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN64721841 |
| Secondary identifying numbers | N/A |
- Submission date
- 23/01/2004
- Registration date
- 23/01/2004
- Last edited
- 16/04/2009
- 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
Mr Douglas McWhinnie
Scientific
Scientific
Milton Keynes General Hospital Trust
Milton Keynes
M6 5AZ
United Kingdom
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Scientific title | |
| Study objectives | Added as of 22/05/2008: To establish the safety, short term outcome, and theatre costs of transabdominal laparoscopic repair of inguinal hernia performed as day surgery. |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Inguinal hernia |
| Intervention | Laparoscopic or open repair of inguinal hernia |
| Intervention type | Other |
| Primary outcome measure | Added 16/04/2009: 1. Morbidity 2. Post-operative pain and use of analgesics 3. Quality of life 4. Theatre costs Outcome was assessed by questionnaires administered to patients daily for 10 days and at six weeks post-operatively and by outpatient review at six weeks. |
| Secondary outcome measures | No secondary outcome measures |
| Overall study start date | 01/12/1992 |
| Completion date | 30/06/1994 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 125 |
| Key inclusion criteria | 1. Primary, unilateral inguinal hernia 2. Aged less than 70 years |
| Key exclusion criteria | Previous major abdominal surgery |
| Date of first enrolment | 01/12/1992 |
| Date of final enrolment | 30/06/1994 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Milton Keynes General Hospital Trust
Milton Keynes
M6 5AZ
United Kingdom
M6 5AZ
United Kingdom
Sponsor information
NHS R&D Regional Programme Register - Department of Health (UK)
Government
Government
The Department of Health
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
| Phone | +44 (0)20 7307 2622 |
|---|---|
| dhmail@doh.gsi.org.uk | |
| Website | http://www.doh.gov.uk |
Funders
Funder type
Government
NHS Executive South East (UK)
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 | 14/10/1995 | Yes | No |
