Pilonidal sinus treatment: studying the options

The PITSTOP study: pilonidal sinus treatment: studying the options

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

ISRCTN

Registry ID

ISRCTN95551898

Enrollment

800

Registered

2019-03-26

Start date

2019-05-01

Completion date

Unknown

Last updated

2024-10-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pilonidal sinus disease Infections and Infestations

Interventions

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 consu

Eligibility

Sex/Gender

All

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
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	—

Measure

Time frame

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

Measure	Time frame
There are no secondary outcome measures	—

Countries

England, Scotland, United Kingdom, Wales

Contacts

Public ContactEmily Strong

EmilyStrong@barnsley.gov.uk+44 (0)114 2222974

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 6, 2026