Condition category
Surgery
Date applied
30/09/2005
Date assigned
30/09/2005
Last edited
13/03/2014
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

Ms Kay Welton

ORCID ID

Contact details

Dept of Colposcopy
Box 224
Addenbrooke's Hospital
Cambridge
CB2 2QQ
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N0544160622

Study information

Scientific title

Acronym

Study hypothesis

The main objective is to improve practice methods that are evidence based, in order to give women who are referred to the colposcopy department the highest standard of care. Those women that undergo a small biopsy of the cervix to obtain histological diagnosis following an abnormal cervical smear require the use of cautery to the area to stop bleeding. This study aims to demonstrate which method is better for the patient as far as speed and follow-up vaginal discharge and/or bleeding. The outcome from the data will ensure that best practice is maintained within the colposcopy clinical setting.

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

Not Specified

Patient information sheet

Condition

Surgery: Cervical punch biopsy

Intervention

Women with mild smears will be sent study information and "Coming for a Colposcopy" leaflet. They will be seen in the colposcopy clinic and, following consultation and consent, women will be colposcoped. If colposcopically the cervix appears to have low grade changes then a biopsy/biopsies will be taken.

They will then be randomly allocated into either the silver nitrate or Monsel's solution group to obtain haemostasis.

The process of cautery will be timed using a stop watch from initial contact of the cauterising agent until haemostasis is obtained.

The women will be asked to keep a record of their discharge and if acceptable will be telephoned one week post procedure to ask about their findings. If the women prefer not to be contacted by phone or are not obtainable on the phone then a follow-up sheet will be given to them with a pre-paid envelope for them to send it in.

Intervention type

Procedure/Surgery

Phase

Not Specified

Drug names

Primary outcome measures

The primary outcome is the length of time taken to obtain haemostasis following a cervical punch biopsy

Secondary outcome measures

Not provided at time of registration

Overall trial start date

01/01/2005

Overall trial end date

01/01/2007

Reason abandoned

Eligibility

Participant inclusion criteria

To ensure that a representative sample is taken from women in the Cambridge area who are referred to the colposcopy clinic with a mildly abnormal cervical smear, consecutive women from the referral list will be sent the study information leaflet. The referral list is obtained from the colposcopy data base and consists of women that have abnormal smears requiring colposcopy referred from the cytology laboratory. The list is random in that it is not in order of age, name or severity of smear.

Participant type

Patient

Age group

Not Specified

Gender

Female

Target number of participants

30 participants in each of the two groups

Participant exclusion criteria

Women will be excluded from the study if they are pregnant, have a known infection or are on anti-coagulation therapy.

Recruitment start date

01/01/2005

Recruitment end date

01/01/2007

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Dept of Colposcopy
Cambridge
CB2 2QQ
United Kingdom

Sponsor information

Organisation

Department of Health

Sponsor details

Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
+44 (0)20 7307 2622
dhmail@doh.gsi.org.uk

Sponsor type

Government

Website

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

Funders

Funder type

Government

Funder name

Cambridge Consortium - Addenbrooke's (UK), NHS R&D Support Funding

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