Unroofing Curettage for Pilonidal Disease

October 25, 2022 updated by: Alpaslan Şahin, Ankara Diskapi Training and Research Hospital

Unroofing Curettage for Treating Simple and Complex Sacrococcygeal Pilonidal Disease

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Observational

Enrollment (Actual)

203

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Ankara, Turkey, 06110
        • Ankara Diskapi Training and Research Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Consecutive patients aged 18 years or older who applied for simple and complex SPD treatment between April 2016 and September 2018 and preferred the UC surgery from all the treatment options offered by the physician.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
unroofing curettage
Surgery was performed with the patient lying in the prone position under local anesthesia. Next, a local anesthetic agent comprising a solution of lidocaine (20 mg/mL) and adrenaline (0.0125 mg/mL) was diluted with distilled water in a 1:2 ratio and applied. 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.
Procedure: unroofing curettage
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Recurrence
Time Frame: 15 days
After healing was complete, any new sinus orifice or discharge from the wound was defined as disease recurrence.
15 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
complete healing time
Time Frame: 15 days
time after surgery until the wound is completely epithelialized
15 days
VAS pain score
Time Frame: 15 days
Visual analog scale for pain
15 days
time to return to daily activities
Time Frame: 15 days
time after surgery until the to return to daily activities
15 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ankara Diskapi Training and Research Hospital

Investigators

  • Principal Investigator: Engin Olcucuoglu, MD, Ankara Diskapi Training and Research Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 27, 2022

Primary Completion (Actual)

May 2, 2022

Study Completion (Actual)

May 5, 2022

Study Registration Dates

First Submitted

February 26, 2022

First Submitted That Met QC Criteria

April 15, 2022

First Posted (Actual)

April 21, 2022

Study Record Updates

Last Update Posted (Actual)

October 27, 2022

Last Update Submitted That Met QC Criteria

October 25, 2022

Last Verified

October 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Pilonidal Disease surgery

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Nothing

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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