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Status unknownNCT04217824Updated Jul 9, 2020

Comparison of Karydakis and Limberg Flap Treatment of Pilonidal Sinus in Adolescent. a Prospective, Randomised Study

An interventional study of pilonidal sinus excision in Pilonidal Sinus and Postoperative Complications, sponsored by Kahramanmaras Sutcu Imam University. Status unknown at 1 site in Turkey. Open to participants aged 10 Years to 18 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-07-09.

Sponsored by Kahramanmaras Sutcu Imam University · Not applicable, Interventional, and Other

The sponsor has not verified this record recently (last verified Jul 2020), so the status shown — last known as Recruiting — may be out of date.

From the registry’s dates

  • Registered 7 months after the study started (first participant enrolled May 2019, registered Jan 2020).
Phase
Not applicable
Study type
Interventional
Enrollment
90
Allocation
Randomized
Ages
10 Years to 18 Years
Sex
All
01

Study summary

Pilonidal sinus disease (PSD) is a chronic inflammation and infection of the sacrococcygeal region. Produces clinic findings with abscess and discharge in the sacrococcygeal region or painful sinus tract in the natal cleft. Its incidence rate among Turkish servicemen is reported to be 8.8% in a study. Although pilonidal sinus disease is common in men, this is the opposite in adolescence. Because adolescent girls are 2 or 3 times more.

Karydakis flap and Limberg flap operations widely preferred in recent years in the surgical treatment of PSD. In our study, we aim to compare these two techniques prospectively and randomly.

Read the detailed description

The best treatment technique for pilonidal sinus disease (PSD) is still controversial. While some researchers prefer minimally invasive methods, some researchers prefer surgical treatment. The most important concern in surgical treatment options is the prolongation of the disease recovery time and recurrence of the disease. Complications that may develop after treatment prolong the treatment period. The aim of this prospective, randomized study was to compare the results of the widely used Limberg and Karydakis flap operations in recent years. The parameters that will be used in the comparison will be an infection, recurrence and wound decomposition.

02

Conditions studied

  • Pilonidal Sinus
  • Postoperative Complications

Keywords

  • pilonidal sinus
  • presakral apse
  • limberg flap
  • karydakis flap
03

In context

Pilonidal Sinus

107 studies on the registry are indexed under Pilonidal Sinus; 31 are open to participants now.

This study's planned enrollment of 90 is above the median of 80 across 73 interventional studies indexed under Pilonidal Sinus.

Browse Pilonidal Sinus studies →

Lead sponsor

Kahramanmaras Sutcu Imam University is the lead sponsor of 192 studies on the registry; 40 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
10 Years to 18 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • Pilonidal sinus disease

Exclusion criteria

Exclusion Criteria:

  • Other disease than pilonidal sinus disease.
05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Outcomes assessor)
Enrollment
90 participants (estimated)

Study arms

  • Active comparator
    karydakis flap

    An asymmetric elliptical excision is performed, defective tissues between the lower and upper ends are removed until they reach healthy borders. The wound edge is then mobilized and the flap is slid over the corresponding wound edge by suturing to the fascia and the skin to the appropriate wound layers. Thus, the gluteal groove is lateralized. Subcutaneous tissue and skin are closed.

    Procedure: pilonidal sinus excision

  • Active comparator
    limberg flap

    Rhomboid excision and pilonidal sinuses together with damaged tissue. On the right side of the patient, the intact skin is shifted to the medial area where the tissues are removed without tension. Thus, the defective part and gluteal groove are corrected.

    Procedure: pilonidal sinus excision

Interventions

  • Procedurepilonidal sinus excision

    Closure of the defect in pilonidal sinus excision with one of the randomly selected flap methods.

06

What researchers measure

Primary outcomes

  1. Postoperative recurrence

    pain, swelling and redness in examination

    Time frame: 1 month

Secondary outcomes

  1. Postoperative infection

    purulent drainage

    Time frame: 1 week

  2. Postoperative wound dehiscence

    wound separation

    Time frame: 1 week

07

Study locations

1 of 1 sites recruiting
  • Kahramanmaras Sutcu Imam University
    Kahramanmaras, Onikisubat 46050, Turkey
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 9, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT04217824
Lead sponsor
Kahramanmaras Sutcu Imam University
Responsible party
Ahmet Gökhan Güler (assistant professor, Kahramanmaras Sutcu Imam University) — Principal investigator
First posted
Jan 3, 2020
Start date
May 22, 2019
Primary completion
May 22, 2021 (estimated)
Completion
May 22, 2021 (estimated)
Last update
Jul 9, 2020

Study contacts

ahmet gokhan guler
Contact
drgokhanguler@gmail.com
+905057702633
ali erdal karakaya
Contact
dralierdal@yahoo.com
+905326313017
ahmet gökhan güler
principal investigator · kahramanmarasSUI

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jul 2020. You cannot join it, but the record below documents what was studied.

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