Total versus subtotal hysterectomy: a prospective, randomised, multi-centre study of the effects on urinary, sexual and bowel function

ISRCTN ISRCTN51860966
DOI https://doi.org/10.1186/ISRCTN51860966
Secondary identifying numbers REC00076
Submission date
23/01/2004
Registration date
23/01/2004
Last edited
18/11/2010
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Urological and Genital Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Isaac Manyonda
Scientific

St George's Healthcare NHS Trust
Department of Obstetrics & Gynaecology
St George's Hospital
London
SW7 0QT
United Kingdom

Email imanyond@sghms.ac.uk

Study information

Study designRandomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeTreatment
Scientific title
Study objectivesTo determine whether subtotal abdominal hysterectomy results in better bladder, bowel or sexual function than total abdominal hysterectomy
Ethics approval(s)Not provided at time of registration
Health condition(s) or problem(s) studiedUrological and genital diseases: Menstrual disorders
InterventionSubtotal hysterectomy vs total hysterectomy
Intervention typeOther
Primary outcome measureMeasures of bladder, bowel and sexual function at 12 months
Secondary outcome measuresNot provided at time of registration
Overall study start date01/01/1996
Completion date01/01/1999

Eligibility

Participant type(s)Patient
Age groupAdult
SexFemale
Target number of participantsNot provided at time of registration
Key inclusion criteriaWomen referred for hysterectomy because of benign disease; most of the women were premenopausal
Key exclusion criteriaAged 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
Date of first enrolment01/01/1996
Date of final enrolment01/01/1999

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

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

Sponsor information

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

The Department of Health
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

Phone +44 (0)20 7307 2622
Email dhmail@doh.gsi.org.uk
Website http://www.doh.gov.uk

Funders

Funder type

Government

NHS Executive London

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article results 24/10/2002 Yes No