A Single Center Experience in the Management of Pilonidal Disease

Mansoura University

Status: Completed

Conditions: Pilonidal Sinus

Treatments: Procedure: surgery

Study type: Interventional

Funder types: Other

Identifiers

NCT05892198

1122

Details and patient eligibility

About

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.

Full 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.

Enrollment: 101 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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101 participants in 3 patient groups

primary closure

Active Comparator group

Description:

The group in which the pits location were in midline ,underwent excision with primary closure

Treatment:

Procedure: surgery

Rhomboid flap group

Active Comparator group

Description:

in which more lateral pits and pits located \<2cm from mid line natal cleft

Treatment:

Procedure: surgery

Rotational flap group

Active Comparator group

Description:

in which more lateral pits and pits located \>2cm from mid line natal cleft

Treatment:

Procedure: surgery