A Single Center Experience in the Management of Pilonidal Disease

Not Applicable

Completed

• Conditions: Pilonidal Sinus

• Registration Number: NCT05892198
• Lead Sponsor: Mansoura University

Brief 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.

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 Timeline

• Study Start: 2015-01-01
• Primary Completion: 2020-06-30
• Study Completion: 2021-12-30
• Status Verified: 2023-05
• Study First Submitted: 2023-05-28
• Study First Submitted QC: 2023-05-28
• Last Update Submitted: 2023-05-28
• Study First Posted: 2023-06-07
• Last Update Posted: 2023-06-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 101

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
the incidence of complications such as: wound infection, wound dehiscence, postoperative pain.	1 month	complication rate