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NCT03923621 Clinical Trial

Pilonidal Excision Versus Endoscopic Surgery

Pilonidal Sinus Clinical Trial

— PEVES  

Official title:
Pilonidal Excision Versus Endoscopic Surgery

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03923621
Other study ID # RBN955/V1
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date March 2016
Est. completion date January 31, 2019

Study information
Verified date April 2019
Source St Helens & Knowsley Teaching Hospitals NHS Trust
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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

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

Recruitment information / eligibility
Status Completed
Enrollment 39
Est. completion date January 31, 2019
Est. primary completion date January 31, 2019
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 16 Years and older
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Procedure:
• EPSiT
Specialised fistuloscope to indentify sinus tracts, cautery tracts, remove causative hair, irrigation.
• Excision
Surgery to remove all affected tissue, followed by wound closure.

Locations
Country Name City State
United Kingdom St Helens & Knowsley Hospitals NHS Trust Prescot Merseyside

Sponsors (1)
Lead Sponsor Collaborator
St Helens & Knowsley Teaching Hospitals NHS Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome
Type Measure Description Time frame Safety issue
Primary Complication rate As described by Dindo et al 2004 12 months
Secondary Quality of life (QoL) QoL utilising validated tool 12 months
See also
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