DoC study
Research type
Research Study
Full title
The validation of a simple and instrument-free technique to measure the depth of the natal cleft.
IRAS ID
291048
Contact name
Asha Senapati
Contact email
Sponsor organisation
London North West University Hospital NHS Trust
Duration of Study in the UK
1 years, 0 months, 0 days
Research summary
Pilonidal disease (PND) is an inflammatory reaction corresponding to the hairy area between the buttocks which causes swelling and development of pits and sinuses under the skin. The disorder sometimes causes no trouble, while others get recurrent infections or abscesses with persistent discharge of fluid requirint surgical intervention.
As there is such a diversity in surgical operations described in the literature, there is a lack of consensus on surgical management of pilonidal disease. Failure of wound healing in the midline is a serious clinical problem, which is often due to the persistence of a deep natal cleft. Future recurrence of disease is also common, and it is believed that this occurs partly also due to a persisting deep natal cleft that permits loose hairs to collect, triggering the cycle of infection once more. Operations such as the Bascoms and Limberg procedure, as well as the cleft closure that is often used in our trust, flatten the cleft as part of the procedure, and the lower recurrence rate could be attributed to this.
There have been an increasing number of studies examining the relationship between the depth of cleft and post-operative complications. However there has not been an agreed, simple and effective technique to measure the depth of the natal cleft described in the literature. Karin et al (2015) in their study found that the depth of the natal cleft was an important factor, showing a positive relationship with time of healing.
Previously, the only described method of depth measurement was by Akinci et al (2009), with a specific tool developed for this very purpose. However, the site at which the depth is measured is critical and this has not been fully explained in previous publications. We propose a novel technique to measure the natal cleft/intergluteal groove.
REC name
West of Scotland REC 3
REC reference
21/WS/0119
Date of REC Opinion
16 Nov 2021
REC opinion
Further Information Favourable Opinion