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

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posted on 2019-04-09, 08:03 authored by Steven Brown, Daniel HindDaniel Hind, Erin Beal, Catherine Graham, Craig Wilkinson, Jon Lund, Asha Senapati, Jonathon Morton, Christine Moffatt, Matthew Lee, Peter Vaughan Shaw, Philip ShackleyPhilip Shackley, Michael BradburnMichael Bradburn, Ellen LeeEllen Lee, Peter Wysocki

The PITSTOP study is a multi centre UK observational study looking at the treatment outcomes for pilonidal sinus disease. To identify healing rates, recurrence and re-intervention, we will recruit consecutive, consenting adults with pilonidal sinus, considered suitable for surgery in NHS trusts with large pilonidal practices. Classification will be by anatomy/pathology of pit and tracks. We will record method of excision (minimal, major, curettage) and closure (none, midline, lateral, flap, glue, phenol injection).

A survey of current practice will be conducted with current consultants in the UK also to assess current treatment practices for pilonidal sinus disease.

To get an overview of patient views and experiences as well as assess which interventions patients would rather avoid and which outcomes are they most value, we will conduct brief semi-structured interviews. This is to assess which interventions patients would rather avoid and which outcomes they most value.

A Discrete Choice Experiment will also be completed. Discrete choice experiments (DCE) are an attribute-based measure of benefit, based on the assumption that health-care interventions, services or policies can be described by their attributes.

A consensus regarding the sub-groups of patients for whom the various interventions may be suited will be generated, along with a consensus working with clinicians and patients, together with a consensus meeting defining appropriate comparators and valued outcomes for any future randomised controlled trial. To do this, a modified nominal group technique consensus 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.


NIHR HTA 17/17/02


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