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Endoscopic Pilonidal Sinus Treatment (EPSIT) Versus Sinus Laser Closure (SiLaC) Versus Lay Open Technique

Primary Purpose

Pilonidal Sinus

Status
Unknown status
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Endoscopic Pilonidal sinus treatment (EPSIT) versus Sinus Laser Closure (SiLaC) versus lay open technique
Sponsored by
Mansoura University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pilonidal Sinus

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • patients with symptoms from sacrococcygeal pilonidal sinus .

Exclusion Criteria:

  • Abscess formation
  • Immunodeficiency.
  • Patients with congenital asymptomatic pits.
  • Patient with psychiatric disease disabling surgical intervention. . Pregnant females.

Sites / Locations

  • Mansoura UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Active Comparator

Arm Label

Endoscopic Pilonidal sinus treatment (EPSIT)

Sinus Laser Closure (SiLaC)

lay open technique

Arm Description

Endoscopic Pilonidal sinus treatment (EPSIT)

Sinus Laser Closure (SiLaC)

lay open technique

Outcomes

Primary Outcome Measures

Recurrence
Recurrence of pilonidal sinus after treatment

Secondary Outcome Measures

Full Information

First Posted
June 3, 2020
Last Updated
June 5, 2020
Sponsor
Mansoura University
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1. Study Identification

Unique Protocol Identification Number
NCT04418336
Brief Title
Endoscopic Pilonidal Sinus Treatment (EPSIT) Versus Sinus Laser Closure (SiLaC) Versus Lay Open Technique
Official Title
Endoscopic Pilonidal Sinus Treatment (EPSIT) Versus Sinus Laser Closure (SiLaC) Versus Lay Open Technique
Study Type
Interventional

2. Study Status

Record Verification Date
May 2020
Overall Recruitment Status
Unknown status
Study Start Date
June 1, 2020 (Actual)
Primary Completion Date
June 1, 2021 (Anticipated)
Study Completion Date
June 2, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Mansoura University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
Aim of the work To compare Sinus Laser closure versus 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pilonidal Sinus

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Endoscopic Pilonidal sinus treatment (EPSIT)
Arm Type
Active Comparator
Arm Description
Endoscopic Pilonidal sinus treatment (EPSIT)
Arm Title
Sinus Laser Closure (SiLaC)
Arm Type
Active Comparator
Arm Description
Sinus Laser Closure (SiLaC)
Arm Title
lay open technique
Arm Type
Active Comparator
Arm Description
lay open technique
Intervention Type
Procedure
Intervention Name(s)
Endoscopic Pilonidal sinus treatment (EPSIT) versus Sinus Laser Closure (SiLaC) versus lay open technique
Intervention Description
Endoscopic Pilonidal sinus treatment (EPSIT) versus Sinus Laser Closure (SiLaC) versus lay open technique in sacrococcygeal Pilonidal sinus treatment
Primary Outcome Measure Information:
Title
Recurrence
Description
Recurrence of pilonidal sinus after treatment
Time Frame
one year

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: patients with symptoms from sacrococcygeal pilonidal sinus . Exclusion Criteria: Abscess formation Immunodeficiency. Patients with congenital asymptomatic pits. Patient with psychiatric disease disabling surgical intervention. . Pregnant females.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mohamed Arnouse
Phone
01099222561
Email
drmhamdy@mans.edu.eg
Facility Information:
Facility Name
Mansoura University
City
Mansoura
State/Province
Dakahlia
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mohamed Hamada Mohamed Hamada
Phone
+20 109 212 7930
Email
irb.mfm@hotmail.com

12. IPD Sharing Statement

Learn more about this trial

Endoscopic Pilonidal Sinus Treatment (EPSIT) Versus Sinus Laser Closure (SiLaC) Versus Lay Open Technique

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