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Intervetional Lay Open and Curettage Versus Endoscopic (E.P.Si.T) Method in the Treatment of Sacrococcygeal Pilonidal Sinus Disease

Primary Purpose

Endoscopic Pilonidal Sinus

Status
Unknown status
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Lay open and curettage
Endoscopic (E.P.Si.T) method
Sponsored by
Mansoura University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Endoscopic Pilonidal Sinus

Eligibility Criteria

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

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

Sites / Locations

  • Mansoura UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Lay open and curettage

Endoscopic (E.P.Si.T) method

Arm Description

Lay open and curettage in Pilonidal sinus

Endoscopic (E.P.Si.T) method in the treatment of sacrococcygeal pilonidal sinus disease

Outcomes

Primary Outcome Measures

recurrence rate
recurrence rate of pilonidal sinus symptoms after healing

Secondary Outcome Measures

Full Information

First Posted
June 3, 2020
Last Updated
June 17, 2020
Sponsor
Mansoura University
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1. Study Identification

Unique Protocol Identification Number
NCT04418310
Brief Title
Intervetional Lay Open and Curettage Versus Endoscopic (E.P.Si.T) Method in the Treatment of Sacrococcygeal Pilonidal Sinus Disease
Official Title
Lay Open and Curettage Versus Endoscopic (E.P.Si.T) Method in the Treatment of Sacrococcygeal Pilonidal Sinus Disease
Study Type
Interventional

2. Study Status

Record Verification Date
May 2020
Overall Recruitment Status
Unknown status
Study Start Date
June 12, 2020 (Actual)
Primary Completion Date
June 2021 (Anticipated)
Study Completion Date
July 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 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.

6. Conditions and Keywords

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

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
Lay open and curettage
Arm Type
Active Comparator
Arm Description
Lay open and curettage in Pilonidal sinus
Arm Title
Endoscopic (E.P.Si.T) method
Arm Type
Active Comparator
Arm Description
Endoscopic (E.P.Si.T) method in the treatment of sacrococcygeal pilonidal sinus disease
Intervention Type
Procedure
Intervention Name(s)
Lay open and curettage
Intervention Description
Lay open and curettage
Intervention Type
Procedure
Intervention Name(s)
Endoscopic (E.P.Si.T) method
Intervention Description
Endoscopic (E.P.Si.T) method
Primary Outcome Measure Information:
Title
recurrence rate
Description
recurrence rate of pilonidal sinus symptoms after healing
Time Frame
one year

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mohamed Arnouse
Phone
01099222561
Email
drmhamdy@mans.edu.eg
First Name & Middle Initial & Last Name or Official Title & Degree
Mahmoud Abdelnaby
Phone
01099222561
Email
Abdelshafymahmoud@gmail.com
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

Intervetional Lay Open and Curettage Versus Endoscopic (E.P.Si.T) Method in the Treatment of Sacrococcygeal Pilonidal Sinus Disease

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