Intervetional Lay Open and Curettage Versus Endoscopic (E... | NCT04418310

Status Module

Record Verification Date

May 2020

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 12, 2020Actual

Primary Completion Date

Jun 2021Estimated

Completion Date

Jul 2021Estimated

First Submitted Date

Jun 3, 2020

First Submission Date that Met QC Criteria

Jun 4, 2020

First Posted Date

Jun 5, 2020Actual

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

Jun 17, 2020

Last Update Posted Date

Jun 18, 2020Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

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

Aim of the work To compare lay open technique versus Endoscopic pilonidal sinus treatment as regards recurrence rate, operative data, postoperative pain, intra and postoperative complications, healing time and return to daily activity

Detailed Description

Introduction Pilonidal sinus is a very common inflammatory disease of gluteal region (McCallum et al., 2008). Its incidence is 26/100,000 and it usually occurs in working males of age 15 to 30.

The disease itself dates back to 1833 when Herbert Mayo, British Physiologist, Anatomist and Surgeon described it as a sinus containing hair follicles located in the sacrococcygeal region in a woman.

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

30Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Lay open and curettage	Active Comparator	Lay open and curettage in Pilonidal sinus	Procedure: Lay open and curettage
Endoscopic (E.P.Si.T) method	Active Comparator	Endoscopic (E.P.Si.T) method in the treatment of sacrococcygeal pilonidal sinus disease	Procedure: Endoscopic (E.P.Si.T) method

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Lay open and curettage	Procedure	Lay open and curettage	Lay open and curettage

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
recurrence rate	recurrence rate of pilonidal sinus symptoms after healing	one year

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Adult patients of both genders with symptoms from sacrococcygeal pilonidal sinus were included in our study.

Exclusion Criteria:

Abscess formation 2. Immunodeficiency. 3. Patients with congenital asymptomatic pits. 4. Patient with psychiatric disease disabling surgical intervention. 5. Pregnant females

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Mohamed Arnouse	Contact	01099222561		drmhamdy@mans.edu.eg
Mahmoud Abdelnaby	Contact	01099222561		Abdelshafymahmoud@gmail.com

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Mansoura University	Recruiting	Al Mansurah	Dakahlia Governorate		Egypt

Derived Section

Miscellaneous Info Module

Version Holder

Jul 10, 2026

Removed Countries

Not provided

Submission Tracking

No data available

No data is available for this block.

Condition Browse Module

No data available

No data is available for this block.

Intervention Browse Module

MeSH Terms

ID	Term
D003475	Curettage
D004724	Endoscopy
D008722	Methods

ID	Term
D013514	Surgical Procedures, Operative
D003949	Diagnostic Techniques, Surgical
D019937	Diagnostic Techniques and Procedures
D003933	Diagnosis
D019060	Minimally Invasive Surgical Procedures
D008919	Investigative Techniques