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
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
-
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.