NCT03923621

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
39

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2016

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2016

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2019

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

March 26, 2019

Completed
27 days until next milestone

First Posted

Study publicly available on registry

April 22, 2019

Completed
Last Updated

April 22, 2019

Status Verified

April 1, 2019

Enrollment Period

2.9 years

First QC Date

March 26, 2019

Last Update Submit

April 17, 2019

Conditions

Pilonidal Sinus

Keywords

Endoscopic Pilonidal Sinus Treatment (EPSiT)

Outcome Measures

Primary Outcomes (1)

  • Complication rate

    As described by Dindo et al 2004

    12 months

Secondary Outcomes (1)

  • Quality of life (QoL)

    12 months

Study Arms (2)

Experimental - EPSiT

EXPERIMENTAL

Endoscopic Pilonidal Sinus Treatment

Procedure: EPSiT

Control - excision

ACTIVE COMPARATOR

Excision treatment

Procedure: Excision

Interventions

EPSiTPROCEDURE

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

Also known as: Endoscopic Pilonidal Sinus Treatment
Experimental - EPSiT
ExcisionPROCEDURE

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

Control - excision

Eligibility Criteria

Age16 Years+
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • ASA I or II
  • Pilonidal disease \<3 previous treatments
  • Previous incision and drainage allowed
  • Over 16 years

You may not qualify if:

  • Co-morbidity \>ASA II
  • Unable to consent themselves
  • Under 16 years
  • Vulnerable adults

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

St Helens & Knowsley Hospitals NHS Trust

Prescot, Merseyside, L35 5DR, United Kingdom

Location

MeSH Terms

Conditions

Pilonidal Sinus

Condition Hierarchy (Ancestors)

CystsNeoplasms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 26, 2019

First Posted

April 22, 2019

Study Start

March 1, 2016

Primary Completion

January 31, 2019

Study Completion

January 31, 2019

Last Updated

April 22, 2019

Record last verified: 2019-04

Data Sharing

IPD Sharing
Will not share

Locations

GB(1)