A Single Center Experience in the Management of Pilonidal Disease

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: Pilonidal Sinus
• Intervention / Treatment: Procedure: surgery

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

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

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

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.	best surgical option based on pits location	6 months
Recurrence rate	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.	complication rate	1 month

Collaborators and Investigators

• Sponsor: Mansoura University

Study record dates

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: primary closure; limberg flap; sacrococcygeal pilonidal sinus; rotational flap
• Additional Relevant MeSH Terms: Neoplasms; Cysts; Pilonidal Sinus
• 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