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 measure
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 (if study stopped)
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
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
Basic results (scientific)
Publication list