Prospective study on menstruation following LLETZ.
Research type
Research Study
Full title
A prospective cohort study on menstruation following large loop excision of the transformation zone (LLETZ).
IRAS ID
164915
Contact name
Farida Bano
Contact email
Duration of Study in the UK
1 years, 0 months, 0 days
Research summary
Large loop excision of transformation zone (LLETZ) is a surgical treatment for pre-cancerous cells of the cervix (neck of the womb). It has been a revolutionary treatment, however, it is associated with complications such as peri-operative bleeding, infection, vaginal discharge, cervical stenosis (narrowing) and preterm birth. Serious complications are thankfully uncommon, but complaints about changes to menstrual periods after LLETZ is very common. We often reassure women that their menstrual periods would return to normal over time, but our understanding on menstruation after LLETZ is still inadequate. Four studies (Lopes 1994, Bigrigg 1994, Williams 2004, TOMBOLA 2009) tried to evaluate menstrual periods post-LLETZ using questionnaire-based cross-sectional surveys, drawbacks of these studies are that they are prone to recall bias and there are no objective measurements of women's menstrual periods. Furthermore, it has been demonstrated that self-assessment or perception of menstrual blood loss bear little or no correlation with measured blood loss (Chimbira 1980, Fraser 1984), we therefore need a well designed prospective study that measures changes to menstrual periods objectively after LLETZ, hence the proposal for this study.
We propose a prospective cohort study design. This involves recruiting patients who require LLETZ treatment at Queen's Hospital, Romford. Patients will have opportunity to view study poster, displayed in the waiting area; time to read through our patient information sheet, and the opportunity to speak to our research co-ordinators. If they agree to take part, they will sign our approved consent form. We aim to recruit 124 patients undergoing LLETZ. In addition, we require 124 patients undergoing colposcopy but not LLETZ, as control group. Participants will be given menstrual diaries and during their routine 6-month and 12-month reviews we will collect detailed objective information about their menstrual periods. Statistical analysis will be used to compare for significant differences in their menstrual periods.
REC name
East of England - Essex Research Ethics Committee
REC reference
14/EE/1280
Date of REC Opinion
8 Dec 2014
REC opinion
Favourable Opinion