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 |
| Secondary identifying numbers | HTA 94/16/03 |
- 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
| 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 | 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 | Operative problems, benefits, complications and costs |
| Secondary outcome measures | Not provided at time of registration. |
| Overall study start date | 01/09/1996 |
| Completion date | 28/02/2001 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Female |
| Target number of participants | 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
- Australia
- South Africa
- United Kingdom
Study participating centre
School of Women's and Infants' Health
Perth
6008
Australia
6008
Australia
Sponsor information
Department of Health (UK)
Government
Government
Quarry House
Quarry Hill
Leeds
LS2 7UE
United Kingdom
| Phone | +44 (0)1132 545 843 |
|---|---|
| Sheila.Greener@doh.gsi.gov.uk | |
| Website | http://www.dh.gov.uk/en/index.htm |
"ROR" |
https://ror.org/03sbpja79 |
Funders
Funder type
Government
NIHR Health Technology Assessment Programme - HTA (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 | 17/01/2004 | Yes | No |
