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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04418310
Other study ID # Epsit Pilonidal sinus
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date June 12, 2020
Est. completion date July 2021

Study information

Verified date May 2020
Source Mansoura University
Contact Mohamed Arnouse
Phone 01099222561
Email drmhamdy@mans.edu.eg
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 30
Est. completion date July 2021
Est. primary completion date June 2021
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility 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

Study Design


Intervention

Procedure:
Lay open and curettage
Lay open and curettage
Endoscopic (E.P.Si.T) method
Endoscopic (E.P.Si.T) method

Locations

Country Name City State
Egypt Mansoura University Mansoura Dakahlia

Sponsors (1)

Lead Sponsor Collaborator
Mansoura University

Country where clinical trial is conducted

Egypt, 

Outcome

Type Measure Description Time frame Safety issue
Primary recurrence rate recurrence rate of pilonidal sinus symptoms after healing one year