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Completed

NCT Number: NCT05851690

Comparison of Two Different Flap Methods in the Treatment of Pilonidal Sinus Disease

Sacrococcygeal pilonidal sinus disease (PSD) has been defined as a disease characterized by chronic inflammation and recurrent infections caused by the movement of hair toward the gluteal sulcus. This condition is especially seen in young men and negatively affects the quality of life of patients and prevents them from performing their work and school activities. The treatment options for PSD range from the use of antibiotics alone to reconstructed excision with tissue flaps. Although the optimal surgical treatment option remains controversial, expectations from the ideal surgical treatment include low recurrence and postoperative complication rates, early wound healing, short hospital stay, early return to work, and good cosmetic outcomes. The aim of this study was to compare the efficacy of the different flap techniques in the surgical treatment of PSD and evaluate the long-term outcomes of patients.

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Key information

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Underwent surgery due to pilonidal sinus disease

Exclusion criteria

  • Patients with a history of previous pilonidal sinus surgery,
  • An acute pilonidal abscess,
  • immunodeficiency,
  • using immunosuppressive drugs,
  • refuse to participate in the study

Treatment and study plan

Surgical treatment of pilonidal sinus disease

Procedure

Advancement flap techniques in surgical treatment of pilonidal sinus disease.

Primary outcomes

  1. Time taken to return to work/school

    Time frame: The patients' return to work ranged from 11 to 49 days.

    Time to return to work in daily life after surgery

  2. Postoperative pain

    Time frame: 1 day

    The pain scores of the patients were determined on the first postoperative day. The Visual Analog Scale (VAS), scored from 1 to 10, was administered to the patients to evaluate their postoperative pain levels.

Secondary outcomes

  1. Length of hospital stay

    Time frame: The patients' length of hospital stay ranged from 1 to 4 days.

    Time to discharge from hospital after surgery

  2. Recurrence of the disease

    Time frame: 43 months

    Recurrence of the disease

Sponsors and collaborators

Lead sponsor

Atlas University

Other

Registry information

Official study title

Bilaterally Parallel Elliptic Flap Versus Karydakis Flap in Pilonidal Sinus Disease: A Randomized Controlled Trial

Important dates

Study start
2016
Primary completion
2017
Study completion
2020
First posted
May 10, 2023
Registry last updated
May 10, 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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