Pilonidal Excision Versus Endoscopic Surgery

Not Applicable

Completed

• Conditions: Pilonidal Sinus

• Registration Number: NCT03923621
• Lead Sponsor: St Helens & Knowsley Teaching Hospitals NHS Trust

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

Study Timeline

• Study Start: 2016-03
• Primary Completion: 2019-01-31
• Study Completion: 2019-01-31
• Study First Submitted: 2019-03-26
• Status Verified: 2019-04
• Study First Submitted QC: 2019-04-17
• Last Update Submitted: 2019-04-17
• Study First Posted: 2019-04-22
• Last Update Posted: 2019-04-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 39

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Complication rate	12 months	As described by Dindo et al 2004

Secondary Outcome Measures

Name	Time	Method
Quality of life (QoL)	12 months	QoL utilising validated tool

Trial Locations

Locations (1)

St Helens & Knowsley Hospitals NHS Trust; 🇬🇧 Prescot, Merseyside, United Kingdom