Karydakis Flap Versus Burow's Triangle Advancement Flap in the Surgery of Sacrococcygeal Pilonidal Sinus Disease

September 26, 2023 updated by: Istanbul Sultanbeyli State Hospital

Karydakis Flap Procedure Versus Burow's Triangle Advancement Flap Procedure in the Surgical Treatment of Sacrococcygeal Pilonidal Sinus Disease

In this study, we aim to compare the Karydakis flap and Burow's Triangle Advancement Flap techniques applied in the surgical treatment of pilonidal sinus in terms of complications, time to return to normal activity, and recurrence.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Pilonidal sinus disease (PSD) is a chronic and inflammatory disease that is often generated in the sacrococcygeal region. It is commonly observed in puberty and young adult period and usually affects men. The incidence of pilonidal sinus disease is 26:100,000 and rising globally.

PSD risk factors contain young age, obesity, male gender, Mediterranean ethnicity, deep natal cleft, hairiness, and poor hygiene. It has been shown that PSD incidence increases in parallel with body weight. The precise etiology of pilonidal sinus disease is unclear. Many conservative and surgical methods have been described in treating pilonidal sinus disease. After the sinus area is excised, excision with laying open (secondary healing), excision with primary closure, marsupialization, and various flap techniques can be applied in surgical treatment. The primary principle in treatment is to ensure that the patient returns to normal life as soon as possible and eliminate recurrences. Although the best surgical technique in treating pilonidal sinus is controversial, the ideal operation should be cost-effective, simple to perform, short hospital stay, and have a low recurrence and complication rates. There is no definite consensus on an ideal technique yet.

In this study, we aim to compare the Karydakis flap and Burow's Triangle Advancement Flap techniques applied in the surgical treatment of pilonidal sinus in our clinic in terms of complications (wound dehiscence, seroma, hematoma, surgical site infection), time to return to normal activity, and recurrence.

Study Type

Interventional

Enrollment (Estimated)

80

Phase

  • Not Applicable

Contacts and Locations

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

Study Contact

Study Locations

  • Turkey
      • Istanbul, Turkey, 34935
        • Recruiting
        • Istanbul Sultanbeyli State Hospital
        • Contact:
          • Muhammer Ergenç, MD

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 to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Patients between the ages of 18-65
  • Primary pilonidal sinus disease
  • No abscess and absence of active infection during the operation

Exclusion Criteria:

  • Patients under the age of 18 and over the age of 65
  • Recurrent pilonidal sinus cases
  • Patients with chronic comorbidities such as immunosuppression, collagen tissue disease, insulin-dependent diabetes mellitus, and neurological disease
  • Patients with an ASA score of 3-4
  • Patients with a body mass index greater than 35 kg/m2
  • Patients with drug and alcohol addiction

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

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Karydakis Flap Procedure
Vertical eccentric elliptical incision down to the post-sacral fascia, complete removal of unhealthy tissue, and normal tissue around the cyst and sinus tracts. Mobilization of the medial wound edge and advancement of the skin. Flap along the midline to the post-sacral fascia and suturing its margin to the lateral wound margin.
Procedure: Karydakis Flap Procedure
Pilonidal sinus surgery will be performed with the Karydakis Flap procedure.
Active Comparator: Burow's Triangle Advancement Flap Procedure
The flap is incised along the base of the wedge-shaped defect, and a small Burow's triangle is excised on the opposite side. The skin is mobilized and shifted in the direction of the arrow to close the defect. Excising the small Burow's triangle eliminates a dog ear at the base of the flap.
Procedure: Burow's Triangle Advancement Flap Procedure
Pilonidal sinus surgery will be performed with the Burow's Triangle Advancement Flap procedure.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain score according to the visual analogue scale
Time Frame: 1-3 days
Postoperative pain after surgery ( measured by the visual analog score with 1 being minimum score and 10 being maximum score)
1-3 days
Postoperative wound healing time
Time Frame: 4 to 6 weeks
Number of weeks of complete duration epithelialization of the wound
4 to 6 weeks
Procedure-related complications
Time Frame: 1 to 6 weeks
Number of complications; related to the surgery, Type (wound dehiscence, seroma, hematoma, surgical site infection)
1 to 6 weeks
Time to return to normal activity
Time Frame: 4 to 6 weeks
The number of weeks it passes the patient to return to normal activity.
4 to 6 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Recurrence of Pilonidal Sinus
Time Frame: 6 - 12 months
Number of patients with recurrence pilonidal disease
6 - 12 months

Collaborators and Investigators

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

Sponsor

Istanbul Sultanbeyli State Hospital

Investigators

  • Principal Investigator: Muhammer Ergenç, MD, Istanbul Sultanbeyli State 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)

June 12, 2022

Primary Completion (Estimated)

June 1, 2024

Study Completion (Estimated)

December 1, 2024

Study Registration Dates

First Submitted

March 13, 2022

First Submitted That Met QC Criteria

March 13, 2022

First Posted (Actual)

March 21, 2022

Study Record Updates

Last Update Posted (Actual)

September 28, 2023

Last Update Submitted That Met QC Criteria

September 26, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2022s01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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