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

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ClinicalTrials.gov Identifier: NCT05289297
Recruitment Status : Recruiting
First Posted : March 21, 2022
Last Update Posted : September 28, 2023
Sponsor:
Information provided by (Responsible Party):
Istanbul Sultanbeyli State Hospital

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Pilonidal Sinus Sacrococcygeal Pilonidal Disease Procedure: Karydakis Flap Procedure Procedure: Burow's Triangle Advancement Flap Procedure Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Karydakis Flap Procedure Versus Burow's Triangle Advancement Flap Procedure in the Surgical Treatment of Sacrococcygeal Pilonidal Sinus Disease
Actual Study Start Date : June 12, 2022
Estimated Primary Completion Date : June 1, 2024
Estimated Study Completion Date : December 1, 2024
Arms and Interventions
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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.


Outcome Measures
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Primary Outcome Measures :
  1. 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)

  2. Postoperative wound healing time [ Time Frame: 4 to 6 weeks ]
    Number of weeks of complete duration epithelialization of the wound

  3. Procedure-related complications [ Time Frame: 1 to 6 weeks ]
    Number of complications; related to the surgery, Type (wound dehiscence, seroma, hematoma, surgical site infection)

  4. 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.


Secondary Outcome Measures :
  1. Recurrence of Pilonidal Sinus [ Time Frame: 6 - 12 months ]
    Number of patients with recurrence pilonidal disease


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05289297


Contacts
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Contact: Muhammer Ergenç, MD 902165642400 ext 1321 muhammerergenc@gmail.com

Locations
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Turkey
Istanbul Sultanbeyli State Hospital Recruiting
Istanbul, Turkey, 34935
Contact: Muhammer Ergenç, MD         
Sponsors and Collaborators
Istanbul Sultanbeyli State Hospital
Investigators
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Principal Investigator: Muhammer Ergenç, MD Istanbul Sultanbeyli State Hospital
More Information
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Publications:
Ergenç, M., Uprak, T.K. Gender-specific prevalence of sacrococcygeal pilonidal sinus disease in Turkey: A retrospective analysis of a large cohort. Eur Surg 55, 43-47 (2023). https://doi.org/10.1007/s10353-022-00777-5

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Responsible Party: Istanbul Sultanbeyli State Hospital
ClinicalTrials.gov Identifier: NCT05289297    
Other Study ID Numbers: 2022s01
First Posted: March 21, 2022    Key Record Dates
Last Update Posted: September 28, 2023
Last Verified: September 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Istanbul Sultanbeyli State Hospital:
Karydakis Flap
Pilonidal Cyst
Additional relevant MeSH terms:
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Pilonidal Sinus
Paranasal Sinus Diseases
Cysts
Neoplasms
 Nose Diseases
Respiratory Tract Diseases
Otorhinolaryngologic Diseases