Adnexal Torsion 1.0
Research type
Research Study
Full title
Validation of prediction rules in the diagnosis of adnexal torsion
IRAS ID
144153
Contact name
Jackie Ross
Contact email
Sponsor organisation
King's College Hospital NHS Foundation Trust
Duration of Study in the UK
1 years, 6 months, 4 days
Research summary
This study is to find the symptoms which are strongly associated with adnexal torsion by use of a detailed self-assessed questionnaire in English. Patients presenting with abdominal pain will complete a questionnaire answering specific questions relating to the pain. The outcomes of these patients will then be determined, for example, ectopic pregnancy, ovarian torsion, tubo-ovarian abscess. The questionnaire has been used by a team of gynaecologists in France and each entry has been appointed a number which correlates to how strongly it is associated with adnexal torsion. Prediction rules have been developed based on research in France. This allows efficient triaging of patients who present to A&E with abdominal pain and it enable streamlining of patients to appropriate management plans.
In our study we are planning to recruit female patients presenting to either A&E or the emergency gynaecology unit. These patients will be required to complete a questionnaire. The questionnaire has been developed by researchers in France. The questionnaire has been translated to English and has had comprehensibilty assessed using a cohort of ten patients. The validity of the questionnaire has been tested by translating the questionnaire back into French and ensuring its comprehensibility and reproducibility. Our study will test the questionnaire in a different language and different patient population to assess the accuracy of the questionnaire in predicting adnexal torsion.
Secondary analysis of the data will enable us to determine if there are more appropriate symptom predictors in our population.
The prevalence of adnexal torsion is between 3-6% from the literature search. We are using a prevalence of 3% in order to determine the sample size, with a sensitivity and specificity of 90%, and a positive likelihood ratio of 9.0.REC name
East Midlands - Derby Research Ethics Committee
REC reference
15/EM/0073
Date of REC Opinion
4 Mar 2015
REC opinion
Further Information Favourable Opinion