Skip to main content
OpenTrials
Completed

NCT Number: NCT03923621

Pilonidal Excision Versus Endoscopic Surgery

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Pilonidal Sinus Cysts Neoplasms

Age range

16 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

St Helens & Knowsley Hospitals NHS Trust

Prescot, Merseyside, L35 5DR, United Kingdom

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

EPSiT

Procedure

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

Other names: Endoscopic Pilonidal Sinus Treatment

Excision

Procedure

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

Primary outcomes

  1. Complication rate

    Time frame: 12 months

    As described by Dindo et al 2004

Secondary outcomes

  1. Quality of life (QoL)

    Time frame: 12 months

    QoL utilising validated tool

Sponsors and collaborators

Lead sponsor

St Helens & Knowsley Teaching Hospitals NHS Trust

Other

Registry information

Acronym: PEVES

Important dates

Study start
2016
Primary completion
2019
Study completion
2019
First posted
Apr 22, 2019
Registry last updated
Apr 22, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.