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Completed

NCT Number: NCT05892198

A Single Center Experience in the Management of Pilonidal Disease

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.

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Key information

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Surgery

Procedure

surgery with primary closure, Rhomboid flap , or Rotational flap

Other names: surgical procedure

Primary outcomes

  1. Select the best operative technique as regard the number and distribution of the pits in pilonidal sinus cases.

    Time frame: 6 months

    best surgical option based on pits location

  2. Recurrence rate

    Time frame: 6 months - 1 year

    how many cases developed recurrence

Secondary outcomes

  1. the incidence of complications such as: wound infection, wound dehiscence, postoperative pain.

    Time frame: 1 month

    complication rate

Sponsors and collaborators

Lead sponsor

Mansoura University

Other

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2020
Study completion
2021
First posted
Jun 7, 2023
Registry last updated
Jun 7, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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