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Pilonidal Excision Versus Endoscopic Surgery (PEVES)

Primary Purpose

Pilonidal Sinus

Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
EPSiT
Excision
Sponsored by
St Helens & Knowsley Teaching Hospitals NHS Trust
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pilonidal Sinus focused on measuring Endoscopic Pilonidal Sinus Treatment (EPSiT)

Eligibility Criteria

16 Years - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • St Helens & Knowsley Hospitals NHS Trust

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Experimental - EPSiT

Control - excision

Arm Description

Endoscopic Pilonidal Sinus Treatment

Excision treatment

Outcomes

Primary Outcome Measures

Complication rate
As described by Dindo et al 2004

Secondary Outcome Measures

Quality of life (QoL)
QoL utilising validated tool

Full Information

First Posted
March 26, 2019
Last Updated
April 17, 2019
Sponsor
St Helens & Knowsley Teaching Hospitals NHS Trust
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1. Study Identification

Unique Protocol Identification Number
NCT03923621
Brief Title
Pilonidal Excision Versus Endoscopic Surgery
Acronym
PEVES
Official Title
Pilonidal Excision Versus Endoscopic Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
April 2019
Overall Recruitment Status
Completed
Study Start Date
March 2016 (undefined)
Primary Completion Date
January 31, 2019 (Actual)
Study Completion Date
January 31, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
St Helens & Knowsley Teaching Hospitals NHS Trust

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pilonidal Sinus
Keywords
Endoscopic Pilonidal Sinus Treatment (EPSiT)

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
39 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Experimental - EPSiT
Arm Type
Experimental
Arm Description
Endoscopic Pilonidal Sinus Treatment
Arm Title
Control - excision
Arm Type
Active Comparator
Arm Description
Excision treatment
Intervention Type
Procedure
Intervention Name(s)
EPSiT
Other Intervention Name(s)
Endoscopic Pilonidal Sinus Treatment
Intervention Description
Specialised fistuloscope to indentify sinus tracts, cautery tracts, remove causative hair, irrigation.
Intervention Type
Procedure
Intervention Name(s)
Excision
Intervention Description
Surgery to remove all affected tissue, followed by wound closure.
Primary Outcome Measure Information:
Title
Complication rate
Description
As described by Dindo et al 2004
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Quality of life (QoL)
Description
QoL utilising validated tool
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Facility Information:
Facility Name
St Helens & Knowsley Hospitals NHS Trust
City
Prescot
State/Province
Merseyside
ZIP/Postal Code
L35 5DR
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Pilonidal Excision Versus Endoscopic Surgery

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