Condition category
Urological and Genital Diseases
Date applied
30/09/2004
Date assigned
30/09/2004
Last edited
19/08/2015
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

Mr Kevin Phillips

ORCID ID

Contact details

Department of Women's Health
Castle Hill Hospital
Castle Road
Cottingham
HU16 5JQ
United Kingdom
+44 (0)1842 875875
abc@email.com

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N0084125088

Study information

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

Acronym

Study hypothesis

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

Not provided at time of registration

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

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

Phase

Drug names

Primary outcome measures

Not provided at time of registration

Secondary outcome measures

Not provided at time of registration

Overall trial start date

08/04/2003

Overall trial end date

01/12/2005

Reason abandoned

Eligibility

Participant inclusion criteria

Women attending the clinic for routine check up.

Participant type

Patient

Age group

Adult

Gender

Female

Target number of participants

Not provided at time of registration

Participant exclusion criteria

Not provided at time of registration

Recruitment start date

08/04/2003

Recruitment end date

01/12/2005

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Castle Hill Hospital
Cottingham
HU16 5JQ
United Kingdom

Sponsor information

Organisation

Department of Health

Sponsor details

Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

Sponsor type

Government

Website

http://www.dh.gov.uk/Home/fs/en

Funders

Funder type

Government

Funder name

The North and South Bank Research and Development Consortium (UK)

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

Publication citations

Additional files

Editorial Notes