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

Primary Purpose

Pilonidal Sinus, Sacrococcygeal Pilonidal Disease

Status
Recruiting
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Karydakis Flap Procedure
Burow's Triangle Advancement Flap Procedure
Sponsored by
Istanbul Sultanbeyli State Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pilonidal Sinus focused on measuring Karydakis Flap, Pilonidal Cyst

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Istanbul Sultanbeyli State HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Karydakis Flap Procedure

Burow's Triangle Advancement Flap Procedure

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Recurrence of Pilonidal Sinus
Number of patients with recurrence pilonidal disease

Full Information

First Posted
March 13, 2022
Last Updated
September 26, 2023
Sponsor
Istanbul Sultanbeyli State Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05289297
Brief Title
Karydakis Flap Versus Burow's Triangle Advancement Flap in the Surgery of Sacrococcygeal Pilonidal Sinus Disease
Official Title
Karydakis Flap Procedure Versus Burow's Triangle Advancement Flap Procedure in the Surgical Treatment of Sacrococcygeal Pilonidal Sinus Disease
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 12, 2022 (Actual)
Primary Completion Date
June 1, 2024 (Anticipated)
Study Completion Date
December 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Istanbul Sultanbeyli State Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pilonidal Sinus, Sacrococcygeal Pilonidal Disease
Keywords
Karydakis Flap, Pilonidal Cyst

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Karydakis Flap Procedure
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Burow's Triangle Advancement Flap Procedure
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
Karydakis Flap Procedure
Intervention Description
Pilonidal sinus surgery will be performed with the Karydakis Flap procedure.
Intervention Type
Procedure
Intervention Name(s)
Burow's Triangle Advancement Flap Procedure
Intervention Description
Pilonidal sinus surgery will be performed with the Burow's Triangle Advancement Flap procedure.
Primary Outcome Measure Information:
Title
Pain score according to the visual analogue scale
Description
Postoperative pain after surgery ( measured by the visual analog score with 1 being minimum score and 10 being maximum score)
Time Frame
1-3 days
Title
Postoperative wound healing time
Description
Number of weeks of complete duration epithelialization of the wound
Time Frame
4 to 6 weeks
Title
Procedure-related complications
Description
Number of complications; related to the surgery, Type (wound dehiscence, seroma, hematoma, surgical site infection)
Time Frame
1 to 6 weeks
Title
Time to return to normal activity
Description
The number of weeks it passes the patient to return to normal activity.
Time Frame
4 to 6 weeks
Secondary Outcome Measure Information:
Title
Recurrence of Pilonidal Sinus
Description
Number of patients with recurrence pilonidal disease
Time Frame
6 - 12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Muhammer Ergenç, MD
Phone
902165642400
Ext
1321
Email
muhammerergenc@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Muhammer Ergenç, MD
Organizational Affiliation
Istanbul Sultanbeyli State Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Istanbul Sultanbeyli State Hospital
City
Istanbul
ZIP/Postal Code
34935
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Muhammer Ergenç, MD

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
31641150
Citation
Doll D, Orlik A, Maier K, Kauf P, Schmid M, Diekmann M, Vogt AP, Stauffer VK, Luedi MM. Impact of geography and surgical approach on recurrence in global pilonidal sinus disease. Sci Rep. 2019 Oct 22;9(1):15111. doi: 10.1038/s41598-019-51159-z.
Results Reference
background
PubMed Identifier
30440104
Citation
Harries RL, Alqallaf A, Torkington J, Harding KG. Management of sacrococcygeal pilonidal sinus disease. Int Wound J. 2019 Apr;16(2):370-378. doi: 10.1111/iwj.13042. Epub 2018 Nov 15.
Results Reference
background
PubMed Identifier
32681319
Citation
Luedi MM, Schober P, Stauffer VK, Diekmann M, Doll D. Global Gender Differences in Pilonidal Sinus Disease: A Random-Effects Meta-Analysis. World J Surg. 2020 Nov;44(11):3702-3709. doi: 10.1007/s00268-020-05702-z. Epub 2020 Jul 17.
Results Reference
background
PubMed Identifier
31113167
Citation
Alvandipour M, Zamani MS, Ghorbani M, Charati JY, Karami MY. Comparison of Limberg Flap and Karydakis Flap Surgery for the Treatment of Patients With Pilonidal Sinus Disease: A Single-Blinded Parallel Randomized Study. Ann Coloproctol. 2019 Dec 31;35(6):313-318. doi: 10.3393/ac.2018.09.27. Epub 2019 May 22.
Results Reference
background
PubMed Identifier
20122682
Citation
Can MF, Sevinc MM, Hancerliogullari O, Yilmaz M, Yagci G. Multicenter prospective randomized trial comparing modified Limberg flap transposition and Karydakis flap reconstruction in patients with sacrococcygeal pilonidal disease. Am J Surg. 2010 Sep;200(3):318-27. doi: 10.1016/j.amjsurg.2009.08.042. Epub 2010 Feb 1.
Results Reference
background
PubMed Identifier
23430349
Citation
Arslan K, Said Kokcam S, Koksal H, Turan E, Atay A, Dogru O. Which flap method should be preferred for the treatment of pilonidal sinus? A prospective randomized study. Tech Coloproctol. 2014 Jan;18(1):29-37. doi: 10.1007/s10151-013-0982-2. Epub 2013 Feb 21.
Results Reference
background
PubMed Identifier
15762217
Citation
Oberemok S, Eliezri Y, Desciak E. Burow's wedge flap revisited. Dermatol Surg. 2005 Feb;31(2):210-6; discussion 216. doi: 10.1111/j.1524-4725.2005.31043. No abstract available.
Results Reference
background
PubMed Identifier
26039952
Citation
Bali I, Aziret M, Sozen S, Emir S, Erdem H, Cetinkunar S, Irkorucu O. Effectiveness of Limberg and Karydakis flap in recurrent pilonidal sinus disease. Clinics (Sao Paulo). 2015 May;70(5):350-5. doi: 10.6061/clinics/2015(05)08. Epub 2015 May 1.
Results Reference
background
Citation
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
Results Reference
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Karydakis Flap Versus Burow's Triangle Advancement Flap in the Surgery of Sacrococcygeal Pilonidal Sinus Disease

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