A Single Center Experience in the Management of Pilonidal Disease

May 28, 2023 updated by: Ahmad Sakr, Mansoura University

A Single Center Experience in the Management of Pilonidal Disease; the Impact of Pits Location on the Choice of the Best Surgical Option.

Sacrococcygeal pilonidal disease (PND) is a common entity affecting the skin and subcutaneous tissue of the upper portion of the natal cleft of the buttocks. It is characterized by the presence of sinus tracts with recurrent inflammation and infection. It poses a significant healthcare problem due to its related morbidity, impaired quality of life, and financial costs.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This acquired disease is caused by negative suction of the hair present in the natal cleft region, leading to a foreign body reaction and subsequent granuloma . It affects 26 per 100000 people, and it mainly affects young men . Surgery for PND is frequently performed in Egypt by general surgeons, with no published data regarding its incidence or prevalence in the Egyptian population.

The PND patient may report different presentations ranging from asymptomatic disease to acute infection and abscess formation. Others may have a chronic disease with recurrent perianal inflammation and discharge.

Multiple surgical options have been described for chronic PND. However, no technique has been universally accepted. The idea of any procedure is to excise the pits with the related sinus tracts leaving healthy tissue as possible to decrease recurrence. The most commonly performed surgical techniques include excision with either primary closure, lay open, or flap-based reconstruction.

Study Type

Interventional

Enrollment (Actual)

101

Phase

  • Not Applicable

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

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Both sexes
  • aging between 18- 60 years old
  • who underwent surgical intervention for the pilonidal sinus (Either primary or recurrent)
  • The surgical intervention includes excision with primary closure or lay open technique, Rhomboid flap and rotational flap.

Exclusion Criteria:

  • surgically unfit due to commodities.
  • those who lost follow up

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: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: primary closure
The group in which the pits location were in midline ,underwent excision with primary closure
Procedure: surgery
surgery with primary closure, Rhomboid flap , or Rotational flap
Other Names:
  • surgical procedure
Active Comparator: Rhomboid flap group
in which more lateral pits and pits located <2cm from mid line natal cleft
Procedure: surgery
surgery with primary closure, Rhomboid flap , or Rotational flap
Other Names:
  • surgical procedure
Active Comparator: Rotational flap group
in which more lateral pits and pits located >2cm from mid line natal cleft
Procedure: surgery
surgery with primary closure, Rhomboid flap , or Rotational flap
Other Names:
  • surgical procedure

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Select the best operative technique as regard the number and distribution of the pits in pilonidal sinus cases.
Time Frame: 6 months
best surgical option based on pits location
6 months
Recurrence rate
Time Frame: 6 months - 1 year
how many cases developed recurrence
6 months - 1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
the incidence of complications such as: wound infection, wound dehiscence, postoperative pain.
Time Frame: 1 month
complication rate
1 month

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)

January 1, 2015

Primary Completion (Actual)

June 30, 2020

Study Completion (Actual)

December 30, 2021

Study Registration Dates

First Submitted

May 28, 2023

First Submitted That Met QC Criteria

May 28, 2023

First Posted (Actual)

June 7, 2023

Study Record Updates

Last Update Posted (Actual)

June 7, 2023

Last Update Submitted That Met QC Criteria

May 28, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1122 (Jian-jun Li)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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