Effective haemostasis following a cervical punch biopsy: a randomised controlled study

ISRCTN ISRCTN20662379
DOI https://doi.org/10.1186/ISRCTN20662379
Secondary identifying numbers N0544160622
Submission date
30/09/2005
Registration date
30/09/2005
Last edited
13/03/2014
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Surgery
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

Ms Kay Welton
Scientific

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

Study information

Study designRandomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeNot Specified
Scientific title
Study objectivesThe 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(s)Not provided at time of registration
Health condition(s) or problem(s) studiedSurgery: Cervical punch biopsy
InterventionWomen 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 typeProcedure/Surgery
Primary outcome measureThe primary outcome is the length of time taken to obtain haemostasis following a cervical punch biopsy
Secondary outcome measuresNot provided at time of registration
Overall study start date01/01/2005
Completion date01/01/2007

Eligibility

Participant type(s)Patient
Age groupNot Specified
SexFemale
Target number of participants30 participants in each of the two groups
Key inclusion criteriaTo 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.
Key exclusion criteriaWomen will be excluded from the study if they are pregnant, have a known infection or are on anti-coagulation therapy.
Date of first enrolment01/01/2005
Date of final enrolment01/01/2007

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

Dept of Colposcopy
Cambridge
CB2 2QQ
United Kingdom

Sponsor information

Department of Health
Government

Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

Phone +44 (0)20 7307 2622
Email dhmail@doh.gsi.org.uk
Website http://www.dh.gov.uk/Home/fs/en

Funders

Funder type

Government

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

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan