A surgical trial will test whether injecting medical glue into a pilonidal sinus—a painful infected pit at the top of the buttocks—lets patients return to normal life faster than other minimally invasive operations. Pilonidal sinus disease is common and rising in incidence, hitting young, working-age people hardest. Surgery is the only cure, but no single procedure has proven best. Current practice varies widely, and recovery can be slow, forcing patients out of work and disrupting relationships and quality of life. The trial compares the most popular technique—pit picking plus glue—against other routine operations, including pit picking alone, Bascom’s procedure, endoscopic treatment, and laser closure. Patients and outcome assessors will not know which operation was performed. If pit picking plus glue proves superior for recovery speed and non-inferior for treatment failure, it could become the standard NHS procedure. That would shift practice away from more invasive surgeries that are often worse than the disease itself, reducing time off work and repeat operations. The trial also includes a health economic analysis, so funders will know whether the glue approach saves money as well as time.
View original technical description
Research question:What is the optimal minimally invasive procedure for non complex and complex pilonidal sinus disease? Background: Pilonidal sinus disease (PSD) is common and the incidence is increasing. Because it affects a young economically active population the condition has a major impact on employment, relationships and quality of life. Surgery is the only curative treatment and multiple surgical approaches have been described with no obvious front runner. The need for improved management of PSD was recognised by the NiHR who commissioned research with the goal of developing a quality future randomised controlled trial. Work has been completed and forms the basis for this trial. From data obtained it is clear that for such a trial to be clinically meaningful, reflective of current UK practice and patient orientated it needs to compare commonly used minimally invasive procedures. Pit picking+glue is the most common of these procedures and is easy to learn. It is therefore the obvious intervention to compare with all of the other minimally invasive interventions employed in the UK. To ensure a high quality trial stratification of disease, patient reported outcomes with robust definitions and a health economic analysis must be included. Aim: To identify whether pit picking+glue is a clinically and cost-effective operation for PSD, compared to other routinely undertaken minimally invasive operations Objectives: - To compare whether pit picking+glue results in a faster return to normal activities than other minimally invasive interventions for PSD - To compare whether pit picking+glue results in equivalent treatment failure rate to other minimally invasive interventions for PSD Methods: Multicentre, double blind randomised superiority and non-inferiority controlled trial with a minimum of 6M follow up carried out at 40 NHS Trusts Participants: those undergoing elective surgery for PSD where the surgeon judges a minimally invasive procedure appropriate Disease classified according to the validated International Pilonidal Sinus (IPS) classification system Randomisation (1:1) to pit picking+glue or another minimally invasive procedure (surgeon’s choice of pit picking alone, Bascom’s 1, endoscopic pilonidal sinus treatment (EPSIT), Sinus Laser assisted closure (SILAC)) Patients/outcome assessors blinded to the intervention Allocation using a computer generated pseudo-random list, stratified by IPS classification, with random permuted blocks of varying sizes Co-primary outcomes; -Time to return to normal daily routine after surgery -Patient reported treatment failure @6M Secondary outcomes; -Time over a 12M period where the patient is unable to do usual activities -Need for further surgery by 12M + study end -Patient reported treatment failure @12M -Clinical assessment of recurrence @12M + study end -Length of stay -Pain day 1,7,21(VAS) -EQ-5D-5L 0,6,12M -Complications -Cardiff wound impact questionnaire @6+12M -Health/anxiety inventory @0,6,12M -Patient health and social care resource use questionnaire Sample size: 610 patients (305 per arm) based on the co-primary outcomes: i) superiority for time to return to normal daily routine and ii) non-inferiority for treatment failure @6M Within-trial economic evaluation using QoL and resource-use data Timelines: M0-8 set up, M9-37 Recruitment/operations, M15-50 follow up, M51-56 write up Impact: Change UK practice avoiding 'surgery being worse than disease'
Plain English summaries and category classifications on this site are generated by AI and may not perfectly reflect the original research.
Is something wrong? Let us know