Contact information
Type
Scientific
Primary contact
Mr Raymond Garry
ORCID ID
Contact details
School of Women's and Infants' Health
University of Western Australia
King Edward Memorial Hospital
Subiaco
Perth
6008
Australia
+61 89340 1331
rgarry@obsgyn.uwa.edu.au
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
HTA 94/16/03
Study information
Scientific title
Acronym
Study hypothesis
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
Not provided at time of registration.
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Condition
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
Phase
Not Specified
Drug names
Primary outcome measures
Operative problems, benefits, complications and costs
Secondary outcome measures
Not provided at time of registration.
Overall trial start date
01/09/1996
Overall trial end date
28/02/2001
Reason abandoned
Eligibility
Participant inclusion criteria
Not provided at time of registration.
Participant type
Patient
Age group
Adult
Gender
Female
Target number of participants
1800
Participant exclusion criteria
Not provided at time of registration.
Recruitment start date
01/09/1996
Recruitment end date
28/02/2001
Locations
Countries of recruitment
South Africa, United Kingdom
Trial participating centre
School of Women's and Infants' Health
Perth
6008
Australia
Sponsor information
Organisation
Department of Health (UK)
Sponsor details
Quarry House
Quarry Hill
Leeds
LS2 7UE
United Kingdom
+44 (0)1132 545 843
Sheila.Greener@doh.gsi.gov.uk
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
NIHR Health Technology Assessment Programme - HTA (UK)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary
2004 results in http://www.ncbi.nlm.nih.gov/pubmed/14711749
Publication citations
-
Results
Garry R, Fountain J, Mason S, Hawe J, Napp V, Abbott J, Clayton R, Phillips G, Whittaker M, Lilford R, Bridgman S, Brown J, The eVALuate study: two parallel randomised trials, one comparing laparoscopic with abdominal hysterectomy, the other comparing laparoscopic with vaginal hysterectomy., BMJ, 2004, 328, 7432, 129, doi: 10.1136/bmj.37984.623889.F6.