A randomised trial to assess the effectiveness, costs and cost-effectiveness of laparoscopic, vaginal and abdominal hysterectomy
| ISRCTN | ISRCTN93016131 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN93016131 |
| Protocol serial number | HTA 94/16/03 |
| Sponsor | Department of Health (UK) |
| Funder | NIHR Health Technology Assessment Programme - HTA (UK) |
- Submission date
- 25/04/2003
- Registration date
- 25/04/2003
- Last edited
- 21/08/2009
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Surgery
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Mr Raymond Garry
Scientific
Scientific
School of Women's and Infants' Health
University of Western Australia
King Edward Memorial Hospital
Subiaco
Perth
6008
Australia
| Phone | +61 89340 1331 |
|---|---|
| rgarry@obsgyn.uwa.edu.au |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Scientific title | |
| Study objectives | The project aims to determine by means of a randomised controlled trial the operative problems, benefits, complications and costs of laparoscopic hysterectomy compared to those associated with both conventional abdominal and vaginal methods of hysterectomy. It will be a multicentre study of 1800 cases collected over an 18 month period by surgeons with differing skill levels from a variety of centres. The study will last for 3 years and will include follow-up assessments at 6 weeks, 3 months, 6 months, and 1 year. The effects of training and experience on outcome will be determined. The objectives of the study are to define the place of laparoscopic hysterectomy in gynaecology and to identify the short-term advantages and disadvantages of this approach for both the patients and the NHS. |
| Ethics approval(s) | Not provided at time of registration. |
| Health condition(s) or problem(s) studied | Urological and genital diseases: Other urological and genital disease |
| Intervention | Please note that, as of 25 January 2008, the end date of this trial was updated from 31 August 1999 to 28 February 2001. Interventions: Laparoscopic, vaginal or abdominal hysterectomy |
| Intervention type | Procedure/Surgery |
| Primary outcome measure(s) |
Operative problems, benefits, complications and costs |
| Key secondary outcome measure(s) |
Not provided at time of registration. |
| Completion date | 28/02/2001 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Female |
| Target sample size at registration | 1800 |
| Key inclusion criteria | Not provided at time of registration. |
| Key exclusion criteria | Not provided at time of registration. |
| Date of first enrolment | 01/09/1996 |
| Date of final enrolment | 28/02/2001 |
Locations
Countries of recruitment
- United Kingdom
- Australia
- South Africa
Study participating centre
School of Women's and Infants' Health
Perth
6008
Australia
6008
Australia
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | 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 | 17/01/2004 | Yes | No |
