Condition category
Urological and Genital Diseases
Date applied
23/01/2004
Date assigned
23/01/2004
Last edited
18/11/2010
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

Dr Isaac Manyonda

ORCID ID

Contact details

St George's Healthcare NHS Trust
Department of Obstetrics & Gynaecology
St George's Hospital
London
SW7 0QT
United Kingdom
imanyond@sghms.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

REC00076

Study information

Scientific title

Acronym

Study hypothesis

To determine whether subtotal abdominal hysterectomy results in better bladder, bowel or sexual function than total abdominal hysterectomy

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: Menstrual disorders

Intervention

Subtotal hysterectomy vs total hysterectomy

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

Measures of bladder, bowel and sexual function at 12 months

Secondary outcome measures

Not provided at time of registration

Overall trial start date

01/01/1996

Overall trial end date

01/01/1999

Reason abandoned

Eligibility

Participant inclusion criteria

Women referred for hysterectomy because of benign disease; most of the women were premenopausal

Participant type

Patient

Age group

Adult

Gender

Female

Target number of participants

Not provided at time of registration

Participant exclusion criteria

Aged over 60 years, suspected cancer, a body weight that exceeded 100 kg, previous pelvic surgery, known endometriosis, abnormal cervical smears, symptomatic uterine prolapse, symptomatic urinary incontinence

Recruitment start date

01/01/1996

Recruitment end date

01/01/1999

Locations

Countries of recruitment

United Kingdom

Trial participating centre

St George's Healthcare NHS Trust
London
SW7 0QT
United Kingdom

Sponsor information

Organisation

NHS R&D Regional Programme Register - Department of Health (UK)

Sponsor details

The Department of Health
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
+44 (0)20 7307 2622
dhmail@doh.gsi.org.uk

Sponsor type

Government

Website

http://www.doh.gov.uk

Funders

Funder type

Government

Funder name

NHS Executive London

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

2002 results in http://www.ncbi.nlm.nih.gov/pubmed/12397189

Publication citations

  1. Results

    Thakar R, Ayers S, Clarkson P, Stanton S, Manyonda I, Outcomes after total versus subtotal abdominal hysterectomy., N. Engl. J. Med., 2002, 347, 17, 1318-1325, doi: 10.1056/NEJMoa013336.

Additional files

Editorial Notes