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
Scientific
Dept of Colposcopy
Box 224
Addenbrooke's Hospital
Cambridge
CB2 2QQ
United Kingdom
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Not Specified |
| Scientific title | |
| Study objectives | 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(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | 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 |
| 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 study start date | 01/01/2005 |
| Completion date | 01/01/2007 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Female |
| Target number of participants | 30 participants in each of the two groups |
| Key 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. |
| Key exclusion criteria | Women will be excluded from the study if they are pregnant, have a known infection or are on anti-coagulation therapy. |
| Date of first enrolment | 01/01/2005 |
| Date of final enrolment | 01/01/2007 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Dept of Colposcopy
Cambridge
CB2 2QQ
United Kingdom
CB2 2QQ
United Kingdom
Sponsor information
Department of Health
Government
Government
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
| Phone | +44 (0)20 7307 2622 |
|---|---|
| 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 share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
