The PITSTOP Study: PIlonidal sinus Treatment: STudying the OPtions - Protocol

Abstract

The PITSTOP study is a multi centre UK observational study\nlooking at the treatment outcomes for pilonidal sinus disease. To identify\nhealing rates, recurrence and re-intervention, we will recruit consecutive,\nconsenting adults with pilonidal sinus, considered suitable for surgery in NHS\ntrusts with large pilonidal practices. \nClassification will be by anatomy/pathology of pit and tracks. We will\nrecord method of excision (minimal, major, curettage) and closure (none,\nmidline, lateral, flap, glue, phenol injection). \n\nA survey of current practice will be conducted with current\nconsultants in the UK also to assess current treatment practices for pilonidal\nsinus disease. \n\nTo get an overview of patient views and experiences as well\nas assess which interventions patients would rather avoid and which outcomes\nare they most value, we will conduct brief semi-structured interviews. This is\nto assess which interventions patients would rather avoid and which outcomes\nthey most value. \n\nA Discrete Choice Experiment will also be completed. Discrete\nchoice experiments (DCE) are an attribute-based measure of benefit, based on\nthe assumption that health-care interventions, services or policies can be\ndescribed by their attributes. \n\nA consensus regarding the sub-groups of patients for whom\nthe various interventions may be suited will be generated, along with a\nconsensus working with clinicians and patients, together with a consensus\nmeeting defining appropriate comparators and valued outcomes for any future\nrandomised controlled trial. To do this, a modified nominal group technique\nconsensus exercise will be undertaken. This study is being conducted by the Clinical Trials Unit at the University of Sheffield. It is sponsored by Sheffield Teaching Hospitals and is Funded by the NIHR HTA. The views expressed are those of the author(s) and not necessarily those of the NIHR or the Department of Health and Social Care.