Pilonidal Excision Versus Endoscopic Surgery

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03923621

Acronym

PEVES

Enrollment

Registered

2019-04-22

Start date

2016-03-31

Completion date

2019-01-31

Last updated

2019-04-22

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

Conditions

Pilonidal Sinus

Keywords

Endoscopic Pilonidal Sinus Treatment (EPSiT)

Brief summary

Compare clinical outcomes of endoscopic pilonidal sinus treatment (EPSiT) with excision treatment with a randomised clinical trial.

Detailed description

Primary outcome: complication rate Secondary outcomes: Quality of life, recurrence rate, length of stay, post operative pain (NRS), return to work time, time to complete wound healing, resource use. Allocation ratio 2:1

Interventions

PROCEDUREEPSiT

Specialised fistuloscope to indentify sinus tracts, cautery tracts, remove causative hair, irrigation.

PROCEDUREExcision

Surgery to remove all affected tissue, followed by wound closure.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

16 Years to No maximum

Healthy volunteers

Yes

Inclusion criteria

* ASA I or II * Pilonidal disease \<3 previous treatments * Previous incision and drainage allowed * Over 16 years

Exclusion criteria

* Co-morbidity \>ASA II * Unable to consent themselves * Under 16 years * Vulnerable adults

Design outcomes

Primary

Measure	Time frame	Description
Complication rate	12 months	As described by Dindo et al 2004

Secondary

Measure	Time frame	Description
Quality of life (QoL)	12 months	QoL utilising validated tool

Countries

United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026