Condition category
Surgery
Date applied
25/04/2003
Date assigned
25/04/2003
Last edited
21/08/2009
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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

http://www.dh.gov.uk/en/index.htm

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

  1. 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.

Additional files

Editorial Notes