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

June 17, 2020 updated by: Mansoura University

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

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
    • Dakahlia
      • Mansoura, Dakahlia, Egypt
        • Recruiting
        • Mansoura University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Lay open and curettage
Lay open and curettage in Pilonidal sinus
Procedure: Lay open and curettage
Lay open and curettage
ACTIVE_COMPARATOR: Endoscopic (E.P.Si.T) method
Endoscopic (E.P.Si.T) method in the treatment of sacrococcygeal pilonidal sinus disease
Procedure: Endoscopic (E.P.Si.T) method
Endoscopic (E.P.Si.T) method

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mansoura University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

June 12, 2020

Primary Completion (ANTICIPATED)

June 1, 2021

Study Completion (ANTICIPATED)

July 1, 2021

Study Registration Dates

First Submitted

June 3, 2020

First Submitted That Met QC Criteria

June 4, 2020

First Posted (ACTUAL)

June 5, 2020

Study Record Updates

Last Update Posted (ACTUAL)

June 18, 2020

Last Update Submitted That Met QC Criteria

June 17, 2020

Last Verified

May 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Epsit Pilonidal sinus

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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