Condition category
Infections and Infestations
Date applied
03/12/2018
Date assigned
26/03/2019
Last edited
03/04/2019
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Plain English Summary

Background and study aims
Pilonidal disease is an infection in the crease of a person's buttocks. The aim of this study is to determine the types of pilonidal disease, to describe the various treatments, to engage with patients and to determine which outcomes they value and which treatments they prefer/do not prefer, and to provide recommendations for further research.

Who can participate?
Patients aged over 18 with symptomatic pilonidal sinus

What does the study involve?
Before the start of the study there will be a survey circulated within the colorectal consultant surgeon network. This survey will seek to determine the methods of surgery currently employed in the field and the ways in which the surgeon learned this technique. The survey will also explore the factors affecting choice of treatment method in relation to disease presentation. Finally, it will seek to investigate the estimated mean recurrence rate for each surgeon. The study will record details of particpants’ pit/track anatomy, surgical treatment, medical events, and health-related quality of life until six months after their operation. It will then describe the combination of treatments currently in use and quantify clinical and patient-reported outcomes associated with each. It will also identify patient-specific disease features that might predict poor outcomes in each treatment group. It will then derive an estimate of the risks associated with common treatment options, ranking the best treatment strategies among patients for whom more than one treatment is considered appropriate. The study will then use case-studies to provide an overview of patient views and experiences of the treatment that they have chosen and received. This will this will also include the views of patients on which treatments they would rather avoid and which outcomes they most value in regards to their treatment options.

What are the possible benefits and risks of participating?
The study is predicted to reach a consensus on which subtypes of pilonidal disease may benefit from which treatment options. Additionally, the research is predicted to reach a surgeon and patient-based consensus on research priorities.

Where is the study run from?
1. Northern General Hospital (lead centre)
2. Addenbrooke's Hospital
3. University Hospital of Wales
4. Countess of Chester Hospital
5. Royal Derby Hospital
6. Royal Infirmary of Edinburgh
7. Glasgow Royal Infirmary
8. Leicester General Hospital
9. Wirral University Teaching Hospital NHS Foundation Trust (WUTH)
10. Manchester Royal Infirmary
11. Norfolk and Norwich University Hospitals NHS Foundation Trust
12. John Radcliffe Hospital
13. Queen Alexandra Hospital
14. Southampton General Hospital
15. St. Mark's Hospital

When is the study starting and how long is it expected to run for?
September 2018 to October 2022

Who is funding the study?
National Institute for Health Research (NIHR) (UK)

Who is the main contact?
1. Erin Beal
erin.beal@sheffield.ac.uk
2. Prof. Steven Brown

Trial website

Contact information

Type

Public

Primary contact

Ms Erin Beal

ORCID ID

http://orcid.org/0000-0002-3754-0639

Contact details

The Innovation Centre
217 Portobello
Sheffield
S1 4DP
United Kingdom
+44 (0)114 2224319
erin.beal@sheffield.ac.uk

Type

Scientific

Additional contact

Prof Steven Brown

ORCID ID

http://orcid.org/0000-0002-0980-2793

Contact details

Northern General Hospital
Herries Rd
Sheffield
S5 7AU
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

40221

Study information

Scientific title

The PITSTOP study: pilonidal sinus treatment: studying the options

Acronym

PITSTOP

Study hypothesis

This is a prospective cohort study to determine the subtypes of pilonidal disease for which the various treatment options are indicated, to describe the various interventions that are used to treat the disease, to engage with patients and determine which outcomes they value and which interventions they prefer/do not prefer and to provide recommendations for further research.

Ethics approval

East of England - Cambridge South Research Ethics Committee
The Old Chapel
Royal Standard Place
Nottingham
NG1 6FS

26/11/2018, ref: 18/EE/0370

Study design

Observational; Design type: Cohort study

Primary study design

Observational

Secondary study design

Cohort study

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details to request a patient information sheet

Condition

Pilonidal sinus disease

Intervention

Design
1. Survey of consultant surgeons
2. Observational cohort
3. Nested mixed method case study
4. Discrete choice experiment
5. Modified nominal group consensus exercise

1. 1. Survey of consultant surgeons
Prior to the commencement of the cohort study there will be a survey circulated within the colorectal consultant surgeon network. The survey will be distributed via email throughout the trainee surgeon network and will be completed in paper and pencil format by consultant colorectal surgeons. This survey will seek to determine the methods of surgery currently employed in the field and the ways in which the surgeon learned this technique. The survey will also explore the factors affecting choice of treatment method in relation to disease presentation. Finally, it will seek to investigate the estimated mean recurrence rate for each surgeon. Currently, there is a lack of evidence outlining the general practice of treatment for pilonidal sinus in the UK. This survey will provide evidence on the techniques currently in use in the UK Health Care system.

2. Observational cohort study
Patients considered suitable for surgery will be identified from GP or secondary care referrals, sent a patient information sheet about the study, detailing the study and all treatment options, and diverted preferably to a specific recruiting clinic. At the clinic, a member of the research team will explain the study to the patient and give them the opportunity to ask any questions. The Principal Investigator or delegated research team member will confirm eligibility and ensure written informed consent is obtained before any patient data is collected. Participants will be advised that they are able to withdraw from the study at any point without any impact on their routine NHS care. As is standard practice, the surgeon will discuss the condition, possible interventions and their advantages and disadvantages. Each participant will be invited to answer a questionnaire on shared decision making (CollaboRATE).

Baseline data, taken face to face immediately after consent, will include patient demographics, social and occupation factors, hair and skin type and previous pilonidal surgery history. Pilonidal disease characteristics, recorded by the surgeon immediately post-op will include pit numbers, track numbers, length, unilateral/bilateral distribution, position, presence of pus and previous surgical scarring. Description of the intervention will include all excision and closure techniques used with a description of major steps taken and potential variants thereof. Use of anaesthetic (general, regional, local), period-operative antibiotics, planned post-operative wound care will also be recorded.

A pain numeric rating scale score will be recorded by the patient on day 1 via text reminder. A trained research nurse will collect structured questionnaire data and a pain numeric rating scale by telephone at seven days and six months, but face-to-face at the routine clinic visit at 4-6 weeks post-operatively.

Hospital notes and patient self-report will be used to assess recurrence and complications at six months. A patient regret score will also be collected at 6 months.

Following the six-month assessment all patients will be contacted with a one-off follow-up at the end of the study unless the participant withdraws consent to further follow up or dies before the study completes. Patients will be contacted via email and telephone with a questionnaire incorporating persistence of symptoms. Hospital and GP records will be used to ascertain A&E attendance, repeat/additional procedures and unresolved complications due to PD, and interactions with primary care (GP consultations for PD, practice or district nurse visits for dressings).

For all of the cohort patients, data will be collected to establish which patients have further treatment for recurrent symptoms or complications following their initial procedure. This will be achieved at the six-week clinic visit following the intervention and by interrogating hospital records, asking the patients’ consultants, writing to patients’ GPs and questioning the patient via telephone interview at 6 months and at the end of the study. At this stage each participant will also be invited to complete a questionnaire on decision regret.

3. Nested mixed method case study
A proportion of patients (at least 20) will be randomly selected using a theoretically based sample and asked to take part in the nested mixed methods substudy. For the participants’ comfort and convenience, we will collect data by telephone or Skype. To assess which outcomes are most valued by patients, and whether there are particular interventions they would rather avoid, the baseline interview guide will adapt key questions from the CODE framework. Interviews will last 15-20 minutes at baseline and 10 minutes at six months.

4. Discrete choice experiment
The data from these interviews will be used to construct a discrete choice experiment. All consented patients will be sent a link to their email addresses via Qualtrics, containing a participant information sheet and simple instructions on how to complete the choice questionnaire. The questionnaire will contain hypothetical choice scenarios (typically range from 8-12 choice sets to avoid cognitive burden) and will ask patients to make choices between two combinations of outcomes with varying levels. The questionnaire should take no more than 15 minutes to complete.

5. Modified nominal group consensus exercise
At the end of the cohort study 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 will take place over half a day, adjacent to the annual ACPGBI. It will be opened to around 40 colorectal surgeons and around 15 patients from across the UK.

Intervention type

Other

Phase

Drug names

Primary outcome measure

As this is a cohort study examining current practice there are no primary outcome measures per se. Identifying appropriate outcome measures for future studies is one of the objectives of the project. The trialists aim to collect the following data:
1. Pain measured using a numeric rating scale at day 1 and day 7 post-operatively. It will also be collected at the routine follow up appointment and at the six month follow up
2. Quality of life measured using the EQ-5D-5L quality of life scale at baseline, at day 7 post operative, at the routine follow up appointment and at the six month follow up
3. Interactions with primary and secondary care asked at day 7 post-operatively, at the routine follow up appointment and at the six month follow up
4. Wound healing and impact measured using the Cardiff Wound Impact Scale at the routine follow up appointment and at the six month follow up
5. Return to normal activities asked using a single question at at baseline, at day 7 post operative, at the routine follow up appointment and at the six month follow up
6. Complications that occur following the intervention identified on the ‘Procedure details’ CRF and any further complications identified at the six-week clinic visit and at the six-month follow-up
7. Recurrence measured through a single question at an end of study follow up call or through hospital notes

Secondary outcome measures

There are no secondary outcome measures

Overall trial start date

01/09/2018

Overall trial end date

01/10/2022

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

1. Consenting patients with pilonidal sinus disease that requires surgical intervention
2. Aged over 18 years

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

Planned Sample Size: 800; UK Sample Size: 800

Participant exclusion criteria

1. Asymptomatic
2. Pregnant
3. Unable to give consent
4. Acute abscess - which is defined as a tender swelling containing pus that presents acutely - the decision on whether or not to operate is at the discretion of the surgeon assessing the patient

Recruitment start date

01/05/2019

Recruitment end date

01/05/2020

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Northern General Hospital (lead centre)
Herries Rd
Sheffield
S5 7AU
United Kingdom

Trial participating centre

Addenbrooke's Hospital
Hills Rd
Cambridge
CB2 0QQ
United Kingdom

Trial participating centre

University Hospital of Wales
Heath Park Way
Cardiff
CF14 4XW
United Kingdom

Trial participating centre

Countess of Chester Hospital
Liverpool Rd
Chester
CH2 1UL
United Kingdom

Trial participating centre

Royal Derby Hospital
Uttoxeter Rd
Derby
DE22 3NE
United Kingdom

Trial participating centre

Royal Infirmary of Edinburgh
51 Little France Cres
Edinburgh
EH16 4SA
United Kingdom

Trial participating centre

Glasgow Royal Infirmary
84 Castle St
Glasgow
G4 0SF
United Kingdom

Trial participating centre

Leicester General Hospital
Gwendolen Rd
Leicester
LE5 4PW
United Kingdom

Trial participating centre

Wirral University Teaching Hospital NHS Foundation Trust (WUTH)
Arrowe Park Hospital Arrowe Park Rd
Birkenhead
CH49 5PE
United Kingdom

Trial participating centre

Manchester Royal Infirmary
Oxford Rd
Manchester
M13 9WL
United Kingdom

Trial participating centre

Norfolk and Norwich University Hospitals NHS Foundation Trust
Colney Ln
Norwich
NR4 7UY
United Kingdom

Trial participating centre

John Radcliffe Hospital
Headley Way Headington
Oxford
OX3 9DU
United Kingdom

Trial participating centre

Queen Alexandra Hospital
-
Portsmouth
PO6 3LY
United Kingdom

Trial participating centre

Southampton General Hospital
Tremona Rd
Southampton
SO16 6YD
United Kingdom

Trial participating centre

St. Mark's Hospital
Watford Rd
Harrow
HA1 3UJ
United Kingdom

Sponsor information

Organisation

Sheffield Teaching Hospitals NHS Foundation Trust

Sponsor details

c/o Dr Mod Harris
Trust Headquarters
8 Beech Hill Road
Sheffield
S10 2SB
United Kingdom
-
modhumita.harris@sth.nhs.uk

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Government

Funder name

NIHR Evaluation, Trials and Studies Co-ordinating Centre (NETSCC); Grant Codes: 17/17/02

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Planned publication in a high impact peer-reviewed journal.

IPD sharing statement
The data sharing plans for the current study are unknown and will be made available at a later date.

Intention to publish date

01/10/2021

Participant level data

To be made available at a later date

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes

03/04/2019: The condition has been changed from "Specialty: Surgery, Primary sub-specialty: General Surgery; Health Category: Skin; Disease/Condition: Infections of the skin and subcutaneous tissue" to "Pilonidal sinus disease" following a request from the NIHR.