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 |
| Protocol serial number | REC00076 |
| Sponsor | NHS R&D Regional Programme Register - Department of Health (UK) |
| Funder | NHS Executive London |
- 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
Scientific
St George's Healthcare NHS Trust
Department of Obstetrics & Gynaecology
St George's Hospital
London
SW7 0QT
United Kingdom
| imanyond@sghms.ac.uk |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Scientific title | |
| Study objectives | To 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) studied | Urological and genital diseases: Menstrual disorders |
| Intervention | Subtotal hysterectomy vs total hysterectomy |
| Intervention type | Other |
| Primary outcome measure(s) |
Measures of bladder, bowel and sexual function at 12 months |
| Key secondary outcome measure(s) |
Not provided at time of registration |
| Completion date | 01/01/1999 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Female |
| Key inclusion criteria | Women referred for hysterectomy because of benign disease; most of the women were premenopausal |
| Key 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 |
| Date of first enrolment | 01/01/1996 |
| Date of final enrolment | 01/01/1999 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
St George's Healthcare NHS Trust
London
SW7 0QT
United Kingdom
SW7 0QT
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not 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 |
