A Single Center Experience in the Management of Pilonidal Disease

NCT ID: NCT05892198

Last Updated: 2023-06-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

101 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-01-01

Study Completion Date

2021-12-30

Brief Summary

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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

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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.

Conditions

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Pilonidal Sinus

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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primary closure

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

Group Type ACTIVE_COMPARATOR

surgery

Intervention Type PROCEDURE

surgery with primary closure, Rhomboid flap , or Rotational flap

Rhomboid flap group

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

Group Type ACTIVE_COMPARATOR

surgery

Intervention Type PROCEDURE

surgery with primary closure, Rhomboid flap , or Rotational flap

Rotational flap group

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

Group Type ACTIVE_COMPARATOR

surgery

Intervention Type PROCEDURE

surgery with primary closure, Rhomboid flap , or Rotational flap

Interventions

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surgery

surgery with primary closure, Rhomboid flap , or Rotational flap

Intervention Type PROCEDURE

Other Intervention Names

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surgical procedure

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Mansoura University

OTHER

Sponsor Role lead

Responsible Party

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Ahmad Sakr

Lecturer of general surgery

Responsibility Role PRINCIPAL_INVESTIGATOR

Other Identifiers

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1122

Identifier Type: -

Identifier Source: org_study_id

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