A Single Center Experience in the Management of Pilonidal Disease

Pilonidal Sinus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05892198
• Other study ID #: 1122
• Status: Completed
• Phase: N/A
• Start date: January 1, 2015
• Est. completion date: December 30, 2021

Study information

• Verified date: May 2023
• Source: Mansoura University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 101
• Est. completion date: December 30, 2021
• Est. primary completion date: June 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Pilonidal Sinus

Intervention

Procedure:
• surgery
surgery with primary closure, Rhomboid flap , or Rotational flap

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Mansoura University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Recurrence rate	how many cases developed recurrence	6 months - 1 year
Secondary	the incidence of complications such as: wound infection, wound dehiscence, postoperative pain.	complication rate	1 month