Pilonidal Excision Versus Endoscopic Surgery | NCT03923621

Studies
Pilonidal Excision Versus Endoscopic Surgery

NCT03923621

Sponsor

St Helens & Knowsley Teaching Hospitals NHS Trust

Status

Completed

Last Update Posted

Apr 22, 2019Actual

Enrollment

39Actual

Phase

Not Applicable

Conditions

Pilonidal Sinus

Interventions

EPSiT
Excision

Countries

United Kingdom

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2019

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 2016

Primary Completion Date

Jan 31, 2019Actual

Completion Date

Jan 31, 2019Actual

First Submitted Date

Mar 26, 2019

First Submission Date that Met QC Criteria

Apr 17, 2019

First Posted Date

Apr 22, 2019Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 17, 2019

Last Update Posted Date

Apr 22, 2019Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

39Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Experimental - EPSiT	Experimental	Endoscopic Pilonidal Sinus Treatment	Procedure: EPSiT
Control - excision	Active Comparator	Excision treatment	Procedure: Excision

Interventions

Name	Type	Description	Arm Group Labels	Other Names
EPSiT	Procedure	Specialised fistuloscope to indentify sinus tracts, cautery tracts, remove causative hair, irrigation.	Experimental - EPSiT

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Complication rate	As described by Dindo et al 2004	12 months

Secondary Outcomes

Measure	Description	Time Frame
Quality of life (QoL)	QoL utilising validated tool	12 months

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

16 Years

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
St Helens & Knowsley Hospitals NHS Trust		Prescot	Merseyside	L35 5DR	United Kingdom

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

ID	Term
D003560	Cysts
D009369	Neoplasms