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Completed

NCT Number: NCT05339828

Unroofing Curettage for Pilonidal Disease

This study aimed to investigate the outcomes of patients who underwent UC as the primary intervention for simple or complex SPD

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Key information

Conditions

Pilonidal Disease Disease Attributes Healing Wound Pathologic Processes Pathological Conditions, Signs and Symptoms Recurrence

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Ankara Diskapi Training and Research Hospital

Ankara, 06110, Turkey (Türkiye)

About this study

Sacrococcygeal pilonidal disease (SPD) is a well-known chronic inflammatory condition that affects young adults; There are many treatment options available today, from simple non-surgical methods to extensive flap procedures. However, elaborate treatment strategies can turn this easily treatable disease into a long-term surgical ordeal, causing complications worse than the primary disease itself.

While, UC is considered safe and effective for treating simple SPD, its suitability for treating complex disease is poor and controversial. To date, no studies have investigated the efficacy of UC specifically when treating complex SPD.

This is the first study to identify and compare efficacy and outcomes after UC in patients classified into simple and complex SPD groups.

This study was conducted at the Department of Surgery of the Diskapi Training and Research Hospital in Ankara, Turkey. The local ethics committee of the institution approved the study protocol (number 27/02, dated March 22, 2016), and written informed consent was obtained from all participants.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Consecutive patients aged 18 years or older

Exclusion criteria

  • acute pilonidal abscess
  • poorly controlled
  • diabetes mellitus,
  • immunosuppressive or coagulation disorders,
  • pregnancy and/or lactation,
  • other acute surgical diseases

Treatment and study plan

unroofing curettage

Procedure

Surgery was performed with the patient lying in the prone position under local anesthesia. The tract was identified by passing small artery forceps along its length and was then opened by cutting directly down onto the forceps. The sinus and all its tracts were completely unroofed, and the base was curetted to remove all necrotic content, hair, and granulation tissue using a dry gauze. The fibrotic back wall was left as intact as possible to avoid delayed healing. Hemostasis was achieved using diathermy with no drainage needed.

Primary outcomes

  1. Recurrence

    Time frame: 15 days

    After healing was complete, any new sinus orifice or discharge from the wound was defined as disease recurrence.

Secondary outcomes

  1. complete healing time

    Time frame: 15 days

    time after surgery until the wound is completely epithelialized

  2. VAS pain score

    Time frame: 15 days

    Visual analog scale for pain

  3. time to return to daily activities

    Time frame: 15 days

    time after surgery until the to return to daily activities

Sponsors and collaborators

Lead sponsor

Ankara Diskapi Training and Research Hospital

Other

Registry information

Official study title

Unroofing Curettage for Treating Simple and Complex Sacrococcygeal Pilonidal Disease

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Apr 21, 2022
Registry last updated
Oct 27, 2022

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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