Pilonidal sinus treatment: studying the options
| ISRCTN | ISRCTN95551898 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN95551898 |
| Secondary identifying numbers | CPMS 40221 |
- Submission date
- 03/12/2018
- Registration date
- 26/03/2019
- Last edited
- 26/09/2024
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Infections and Infestations
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 16 years 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?
University of Sheffield and 28 sites (UK)
When is the study starting and how long is it expected to run for?
September 2018 to March 2023
Who is funding the study?
National Institute for Health Research (NIHR) (UK)
Who is the main contact?
1. Emily Strong
EmilyStrong@barnsley.gov.uk
2. Prof. Steven Brown
3. Prof Daniel Hind
d.hind@sheffield.ac.uk
Contact information
Public
ScHARR
University of Sheffield
Regent Court
30 Regent Street
Sheffield
S1 4DA
United Kingdom
 ORCID ID |
0000-0002-2381-4088 |
|---|---|
| Phone | +44 (0)114 2222974 |
| EmilyStrong@barnsley.gov.uk |
Scientific
Northern General Hospital
Herries Rd
Sheffield
S5 7AU
United Kingdom
| ORCID ID |
0000-0002-0980-2793 |
|---|
Scientific
ScHARR
University of Sheffield
Regent Court
30 Regent Street
Sheffield
S1 4DA
United Kingdom
| ORCID ID |
0000-0002-6409-4793 |
|---|---|
| d.hind@sheffield.ac.uk |
Study information
| Study design | Observational; Design type: Cohort study |
|---|---|
| Primary study design | Observational |
| Secondary study design | Cohort study |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details to request a patient information sheet |
| Scientific title | The PITSTOP study: pilonidal sinus treatment: studying the options |
| Study 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(s) | East of England - Cambridge South Research Ethics Committee The Old Chapel Royal Standard Place Nottingham NG1 6FS 26/11/2018, ref: 18/EE/0370 |
| 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 |
| 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 study start date | 01/09/2018 |
| Overall study end date | 31/03/2023 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 16 Years |
| Sex | Both |
| Target number of participants | Planned Sample Size: 800; UK Sample Size: 800 |
| Total final enrolment | 677 |
| Participant inclusion criteria | Current inclusion criteria as of 04/09/2020: 1. Consenting patients with pilonidal sinus disease that requires surgical intervention 2. Aged over 16 years Previous inclusion criteria: 1. Consenting patients with pilonidal sinus disease that requires surgical intervention 2. Aged over 18 years |
| 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 | 31/03/2022 |
Locations
Countries of recruitment
- England
- Scotland
- United Kingdom
- Wales
Study participating centres
Cambridge
CB2 0QQ
United Kingdom
Cardiff
CF14 4XW
United Kingdom
Chester
CH2 1UL
United Kingdom
Derby
DE22 3NE
United Kingdom
Glasgow
G4 0SF
United Kingdom
Leicester
LE5 4PW
United Kingdom
Arrowe Park Rd
Birkenhead
CH49 5PE
United Kingdom
Manchester
M13 9WL
United Kingdom
Norwich
NR4 7UY
United Kingdom
Headington
Oxford
OX3 9DU
United Kingdom
Portsmouth
PO6 3LY
United Kingdom
Harrow
HA1 3UJ
United Kingdom
Sheffield
S10 2JF
United Kingdom
Edinburgh
EH4 2XU
United Kingdom
Ashton-under-Lyne
OL6 9RW
United Kingdom
High Heaton
Newcastle upon Tyne
NE7 7DN
United Kingdom
York
YO31 8HE
United Kingdom
Warrington Road
Prescot
L35 5DR
United Kingdom
Morriston
Cwmrhydyceirw
Swansea
SA6 6NL
United Kingdom
Salford
M6 8HD
United Kingdom
Yeovil
BA21 4AT
United Kingdom
Taunton
TA1 5DA
United Kingdom
Margate
CT9 4AN
United Kingdom
EX2 5DW
United Kingdom
Ipswich
IP4 5PD
United Kingdom
Aldermaston Road
Basingstoke
RG24 9NA
United Kingdom
DE13 0RB
United Kingdom
Sponsor information
Hospital/treatment centre
c/o Dr Mod Harris
Trust Headquarters
8 Beech Hill Road
Sheffield
S10 2SB
England
United Kingdom
| modhumita.harris@sth.nhs.uk | |
"ROR" |
https://ror.org/018hjpz25 |
Funders
Funder type
Government
No information available
Results and Publications
| Intention to publish date | 01/01/2024 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Data sharing statement to be made available at a later date |
| Publication and dissemination plan | Planned publication in a high-impact peer-reviewed journal. |
| IPD sharing plan | The data sharing plans for the current study are unknown and will be made available at a later date. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| HRA research summary | 28/06/2023 | No | No | ||
| Basic results | 21/03/2024 | 28/03/2024 | No | No | |
| Results article | 24/07/2024 | 25/07/2024 | Yes | No | |
| Results article | Decisional regret | 25/09/2024 | 26/09/2024 | Yes | No |
Additional files
Editorial Notes
26/09/2024: Publication reference and total final enrolment added.
25/07/2024: Publication reference added.
28/03/2024: The basic results have been uploaded as an additional file.
20/11/2023: The intention to publish date has been changed from 01/11/2023 to 01/01/2024.
31/10/2023: The public contact email was updated.
23/10/2023: The intention to publish date was changed from 01/10/2023 to 01/11/2023.
18/09/2023: The intention to publish date was changed from 31/03/2023 to 01/10/2023.
06/02/2023: Contact details updated.
05/04/2022: The following changes have been made:
1. The study contact has been updated.
2. The trial website has been added.
22/09/2021: The following changes have been made:
1. The recruitment end date has been changed from 30/09/2021 to 31/03/2022.
2. The overall trial end date has been changed from 31/03/2022 to 31/03/2023 and the plain English summary has been updated to reflect this change.
16/03/2021: The following changes were made to the trial record:
1. The recruitment end date was changed from 30/03/2021 to 30/09/2021.
2. The overall trial end date was changed from 30/09/2021 to 31/03/2022.
3. The intention to publish date was changed from 01/10/2021 to 31/03/2023.
04/09/2020: The following changes were made to the trial record:
1. The inclusion criteria were updated.
2. The recruitment end date was changed from 30/09/2020 to 30/03/2021.
3. The trial participating centres were updated to remove Southampton General Hospital and Royal Hallamshire Hospital and add Northern General Hospital and Queens Hospital.
04/08/2020: The following changes were made to the trial record:
1. The overall end date was changed from 01/10/2022 to 30/09/2021.
2. The trial participating centre "Kings College Hospital NHS Foundation Trust" was changed to "Basingstoke and North Hampshire Hospital"
3. The plain English summary was updated to reflect these changes.
02/06/2020: The recruitment end date was changed from 01/05/2020 to 30/09/2020.
06/09/2019: The following changes were made to the trial record:
1. The following trial participating centres were added: Royal Hallamshire Hospital, Western General Hospital, Tameside and Glossop Integrated Care NHS Foundation Trust, Newcastle Upon Tyne Hospitals NHS Foundation Trust, York Teaching Hospital NHS Foundation Trust, St Helens and Knowsley Teaching Hospitals NHS Trust, Morriston Hospital, Salford Royal NHS Foundation Trust, Yeovil District Hospital NHS Foundation Trust, Musgrove Park Hospital, Queen Elizabeth The Queen Mother Hospital, Royal Devon & Exeter NHS Foundation Trust, East Suffolk and North Essex NHS Foundation Trust, Kings College Hospital NHS Foundation Trust.
2. The following trial participating centres were removed from the trial record: Northern General Hospital, Royal Infirmary of Edinburgh.
29/08/2019: The scientific contact has been changed from Erin Beal <erin.beal@sheffield.ac.uk> to Emily B Strong <e.b.strong@sheffield.ac.uk>.
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.
