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

Postoperative Complications Clinical Trial

Official title:

a Prospective, Randomized, Double-blind Study. comparıson of Karydakis Flap and Limberg Flap Treatment of Pilonidal Sinus in Adolescent. a Prospective, Randomised Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04217824
• Other study ID #: 2019/04-02
• Status: Recruiting
• Phase: N/A
• Start date: May 22, 2019
• Est. completion date: May 22, 2021

Study information

• Verified date: July 2020
• Source: Kahramanmaras Sutcu Imam University
• Contact: ahmet gokhan guler
• Phone: +905057702633
• Email: drgokhanguler[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 90
• Est. completion date: May 22, 2021
• Est. primary completion date: May 22, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 10 Years to 18 Years

Eligibility

Inclusion Criteria:

• Pilonidal sinus disease

Exclusion Criteria:

• Other disease than pilonidal sinus disease.

Related Conditions & MeSH terms

• Pilonidal Sinus
• Postoperative Complications

Intervention

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

Locations

Country	Name	City	State
Turkey	Kahramanmaras Sutcu Imam University	Kahramanmaras	Onikisubat

Sponsors (1)

Lead Sponsor	Collaborator
Kahramanmaras Sutcu Imam University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Postoperative recurrence	pain, swelling and redness in examination	1 month
Secondary	Postoperative infection	purulent drainage	1 week
Secondary	Postoperative wound dehiscence	wound separation	1 week