NCT05289297

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2022

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 13, 2022

Completed
8 days until next milestone

First Posted

Study publicly available on registry

March 21, 2022

Completed
3 months until next milestone

Study Start

First participant enrolled

June 12, 2022

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2024

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2024

Completed
Last Updated

September 28, 2023

Status Verified

September 1, 2023

Enrollment Period

2 years

First QC Date

March 13, 2022

Last Update Submit

September 26, 2023

Conditions

Pilonidal SinusSacrococcygeal Pilonidal Disease

Keywords

Karydakis FlapPilonidal Cyst

Outcome Measures

Primary Outcomes (4)

  • 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)

    1-3 days

  • Postoperative wound healing time

    Number of weeks of complete duration epithelialization of the wound

    4 to 6 weeks

  • Procedure-related complications

    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

    The number of weeks it passes the patient to return to normal activity.

    4 to 6 weeks

Secondary Outcomes (1)

  • Recurrence of Pilonidal Sinus

    6 - 12 months

Study Arms (2)

Karydakis Flap Procedure

ACTIVE COMPARATOR

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

Burow's Triangle Advancement Flap Procedure

ACTIVE COMPARATOR

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

Interventions

Karydakis Flap ProcedurePROCEDURE

Pilonidal sinus surgery will be performed with the Karydakis Flap procedure.

Karydakis Flap Procedure
Burow's Triangle Advancement Flap ProcedurePROCEDURE

Pilonidal sinus surgery will be performed with the Burow's Triangle Advancement Flap procedure.

Burow's Triangle Advancement Flap Procedure

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Istanbul Sultanbeyli State Hospital

Istanbul, 34935, Turkey (Türkiye)

RECRUITING

Related Publications (9)

  • 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.

    PMID: 31641150BACKGROUND

  • 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.

    PMID: 30440104BACKGROUND

  • 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.

    PMID: 32681319BACKGROUND

  • 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.

    PMID: 31113167BACKGROUND

  • 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.

    PMID: 20122682BACKGROUND

  • 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.

    PMID: 23430349BACKGROUND

  • 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.

    PMID: 15762217BACKGROUND

  • 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.

    PMID: 26039952BACKGROUND

  • 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

    BACKGROUND

MeSH Terms

Conditions

Pilonidal Sinus

Condition Hierarchy (Ancestors)

CystsNeoplasms

Study Officials

  • Muhammer Ergenç, MD

    Istanbul Sultanbeyli State Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Muhammer Ergenç, MD

CONTACT

902165642400muhammerergenc@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 13, 2022

First Posted

March 21, 2022

Study Start

June 12, 2022

Primary Completion

June 1, 2024

Study Completion

December 1, 2024

Last Updated

September 28, 2023

Record last verified: 2023-09

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)