Pilonidal Excision Versus Endoscopic Surgery (PEVES)
April 17, 2019 updated by: St Helens & Knowsley Teaching Hospitals NHS Trust
Compare clinical outcomes of endoscopic pilonidal sinus treatment (EPSiT) with excision treatment with a randomised clinical trial.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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
Study Type
Interventional
Enrollment (Actual)
39
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Merseyside
-
Prescot, Merseyside, United Kingdom, L35 5DR
- St Helens & Knowsley Hospitals NHS Trust
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
12 years and older (Child, Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Experimental - EPSiT
Endoscopic Pilonidal Sinus Treatment
|
Specialised fistuloscope to indentify sinus tracts, cautery tracts, remove causative hair, irrigation.
Other Names:
|
|
Active Comparator: Control - excision
Excision treatment
|
Surgery to remove all affected tissue, followed by wound closure.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Complication rate
Time Frame: 12 months
|
As described by Dindo et al 2004
|
12 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Quality of life (QoL)
Time Frame: 12 months
|
QoL utilising validated tool
|
12 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
March 1, 2016
Primary Completion (Actual)
January 31, 2019
Study Completion (Actual)
January 31, 2019
Study Registration Dates
First Submitted
March 26, 2019
First Submitted That Met QC Criteria
April 17, 2019
First Posted (Actual)
April 22, 2019
Study Record Updates
Last Update Posted (Actual)
April 22, 2019
Last Update Submitted That Met QC Criteria
April 17, 2019
Last Verified
April 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- RBN955/V1
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.