The PITSTOP2 Trial
Pilonidal Sinus Treatment Studying the Options: trial of pit-picking plus fibrin glue vs other minimally invasive surgeries.
Background
Pilonidal sinus disease (PSD) is a condition that usually affects the skin just at the top of the buttocks near the tailbone. It is a chronic condition characterised by a small hole, tunnel (sinus), or pocket (cyst) that develops in the skin. These usually contain hair, dead skin, and debris and can often become infected. Infection will cause pain and swelling in the tailbone area and a pus-filled skin abscess can develop.
PSD is a common condition that is on the rise. Young, working people are also more likely to be affected. It can be disruptive to your job, social life and overall well-being. The cure for PSD usually requires surgery. There are 2 main surgical approaches. One involves removing the affected skin and closing the wound. The other group of operations aims to save the skin by using so-called minimally invasive surgery (MIS). The most appropriate treatment depends on the type and severity of your disease. In some cases a skin-removing operation may be the safest and most effective option. For patients who are suitable for minimally invasive surgery, there are several different procedures that can be used. At the moment, we do not know whether one minimally invasive procedure is better than the others.
About PITSTOP2
The main aim of this trial is to identify whether pit picking + glue is a clinically and cost-effective operation for pilonidal sinus disease, compared to other routinely undertaken minimally invasive operations.
This means:
- To compare whether pit picking + glue results in a significantly faster time to return to normal activities than other minimally invasive interventions for PSD
- To compare whether pit picking + glue results in a similar treatment failure rate to other minimally invasive interventions for PSD
- To compare outcomes after stratifying into non-complex (non-recurrent disease with pits or sinuses confined to the midline) and complex disease (midline disease with secondary sinus/es or abscess scar/s or any disease after treatment with definitive intent).
Sites
TBC
Central Study Staff
| Name | Role | Organisation |
|---|---|---|
| Matthew Lee | Co-Chief Investigator | Sheffield Teaching Hospitals NHS Foundation Trust |
| Stephen Brown | Co-Chief Investigator | Sheffield Teaching Hospitals NHS Foundation Trust |
| Cara Mooney | CTRU oversight | CTRU, The University of Sheffield |
| Robin Chatters | Methodologist | CTRU, The University of Sheffield |
| Marie Hyslop | Trial Manager | CTRU, The University of Sheffield |
Megan Etherington | Research Assistant | CTRU, The University of Sheffield |
| Naomi Roberts | Trial Support Officer | CTRU, The University of Sheffield |
| Ellen Lee | Statistician | CTRU, The University of Sheffield |
| Harry Hill | Health Economist | The University of Sheffield |
Co-Applicants
| Name | Organisation |
|---|---|
| Mr Nilofer Husnoo | Sheffield Teaching Hospitals |
| Professor Christine Moffatt | International Lymphoedema Framework |
| Professor Jonathan Lund | University of Nottingham |
| Sam Rose | Bowel Research UK |
| Frankie Levin | PPI |
Funder
This project is funded by the National Institute for Health Research, Health Technology Assessment (NIHR HTA) Programme (NIHR175072).
Sponsor
Sheffield Teaching Hospitals NHS Foundation Trust.