Portable manometry (Anopress THD): a pilot study
Research type
Research Study
Full title
Ano-rectal physiology (ARP): comparison of reproducibility of results between water perfused and solid state catheters (THD Anopress)
IRAS ID
207753
Contact name
C. J. Vaizey
Contact email
Sponsor organisation
London North West NHS Trust
Duration of Study in the UK
1 years, 0 months, 1 days
Research summary
Anorectal physiology (ARP) is a functional assessment of the anal canal and is considered part of the standard of care for patients with pelvic floor disorders. These tests involve a pressure recording catheter being placed into the anal canal, with anal canal pressures recorded while the patient is relaxed (resting pressures) and with the sphincter clenched (squeeze pressures). The catheters are only 3 mm wide, insertion is painless and there is no morbidity associated with this examination. Assessment of each patient takes approximately 5 minutes at most. At the present time, anal canal function is measured by taking an average of these pressures at 1 cm intervals, an approach that is clearly inaccurate. In the proposed study, patients would have this examination performed twice with two separate catheters that use different technologies. The aim of this study is to compare the results generated by water perfused (our current standard of care) and the new solid state (THD Anopress – used in some European centers) manometry catheters that record more detailed data. The work that we are proposing will not adapt the function or use of the pressure recording catheters in any way; however, we are seeking approval to analyse the data in a novel manner. Specifically, we wish to investigate the clinical utility of two new ways of presenting the large amount of data the new solid state catheters generate, by developing techniques to assess resting and squeeze pressures produced by the anal canal as a whole. It is hoped that these assessments may be capable of replacing the standard means of assessing average maximum resting and squeeze anal canal pressures.
REC name
London - Dulwich Research Ethics Committee
REC reference
16/LO/1577
Date of REC Opinion
25 Oct 2016
REC opinion
Further Information Favourable Opinion