A Single Center Experience in the Management of Pilonidal Disease

Study Overview
=================
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.

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.

Conditions
-----------------
Pilonidal Sinus

Intervention / Treatment
-----------------
* Procedure: surgery


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

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


Arms and Interventions

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

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
sacrococcygeal pilonidal sinus, primary closure, limberg flap, rotational flap