A prospective randomised comparison of surgical treatment and expectant management of intrauterine polyps/fibroids in premenopausal women with abnormal uterine bleeding in an office hysteroscopy setting
| ISRCTN | ISRCTN71229651 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN71229651 |
| Protocol serial number | N0084125088 |
| Sponsor | Department of Health |
| Funder | The North and South Bank Research and Development Consortium (UK) |
- Submission date
- 30/09/2004
- Registration date
- 30/09/2004
- Last edited
- 19/08/2015
- 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
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Mr Kevin Phillips
Scientific
Scientific
Department of Women's Health
Castle Hill Hospital
Castle Road
Cottingham
HU16 5JQ
United Kingdom
| Phone | +44 (0)1842 875875 |
|---|---|
| abc@email.com |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Study type | Participant information sheet |
| Scientific title | A prospective randomised comparison of surgical treatment and expectant management of intrauterine polyps/fibroids in premenopausal women with abnormal uterine bleeding in an office hysteroscopy setting |
| Study objectives | To determine the effect of treatment on the symptoms experienced and to determine the natural history of polyps/fibroids in relation to the symptoms in patients who have intrauterine lesion in situ. |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Urological and Genital Diseases: Polyps/fibroids |
| Intervention | Patients will be randomised preoperatively by a computer generated sequence into one of the two study arms: Hysteroscopic treatment or diagnostic hysteroscopy alone. The control group will comprise of asymptomatic patients undergoing sterilisation who will have diagnostic hysteroscopy. |
| Intervention type | Procedure/Surgery |
| Primary outcome measure(s) | Not provided at time of registration |
| Key secondary outcome measure(s) | Not provided at time of registration |
| Completion date | 01/12/2005 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Female |
| Key inclusion criteria | Women attending the clinic for routine check up. |
| Key exclusion criteria | Not provided at time of registration |
| Date of first enrolment | 08/04/2003 |
| Date of final enrolment | 01/12/2005 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
Castle Hill Hospital
Cottingham
HU16 5JQ
United Kingdom
HU16 5JQ
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? |
|---|---|---|---|---|---|
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
