Prospective randomised trial to evaluate laparoscopic versus open bilayer patch herniorrhaphy for the treatment of primary unilateral inguinal hernia
| ISRCTN | ISRCTN00532630 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN00532630 |
| Protocol serial number | N0084125082 |
| Sponsor | Department of Health |
| Funder | The North and South Bank Research and Development Consortium (UK) |
- Submission date
- 30/09/2004
- Registration date
- 30/09/2004
- Last edited
- 01/05/2015
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Urological and Genital Diseases
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
Mr Colm O'Boyle
Scientific
Scientific
Department of Surgery
Hull Royal Infirmary
Hull
HU3 2JZ
United Kingdom
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Scientific title | Prospective randomised trial to evaluate laparoscopic versus open bilayer patch herniorrhaphy for the treatment of primary unilateral inguinal hernia |
| Study objectives | To evaluate laparoscopic herniorrhaphy under general anaesthetic compared to open patch herniorrhaphy under local anaesthetic in the treatment of primary inguinal hernia. |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Urological and Genital Diseases: Inguinal hernia |
| Intervention | Laparoscopic herniorrhaphy under general anaesthetic compared to open patch herniorrhaphy under local anaesthetic in the treatment of primary inguinal hernia. |
| Intervention type | Other |
| Primary outcome measure(s) |
Not provided at time of registration |
| Key secondary outcome measure(s) |
Not provided at time of registration |
| Completion date | 01/06/2005 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | All |
| Target sample size at registration | 398 |
| Key inclusion criteria | Not provided at time of registration |
| Key exclusion criteria | Not provided at time of registration |
| Date of first enrolment | 29/05/2003 |
| Date of final enrolment | 01/06/2005 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
Hull Royal Infirmary
Hull
HU3 2JZ
United Kingdom
HU3 2JZ
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |