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

Not Applicable

• Conditions: Postoperative Complications; Pilonidal Sinus
• Interventions: Procedure: pilonidal sinus excision

• Registration Number: NCT04217824
• Lead Sponsor: Kahramanmaras Sutcu Imam University

Brief 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.

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.

Study Timeline

• Study Start: 2019-05-22
• Study First Submitted: 2020-01-02
• Study First Submitted QC: 2020-01-02
• Study First Posted: 2020-01-03
• Status Verified: 2020-07
• Last Update Submitted: 2020-07-08
• Last Update Posted: 2020-07-09
• Primary Completion: 2021-05-22
• Study Completion: 2021-05-22

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 90

Inclusion Criteria

• Pilonidal sinus disease

Exclusion Criteria

• Other disease than pilonidal sinus disease.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
karydakis flap	pilonidal sinus excision	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.
limberg flap	pilonidal sinus excision	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.

Primary Outcome Measures

Name	Time	Method
Postoperative recurrence	1 month	pain, swelling and redness in examination

Secondary Outcome Measures

Name	Time	Method
Postoperative infection	1 week	purulent drainage
Postoperative wound dehiscence	1 week	wound separation

Trial Locations

Locations (1)

Kahramanmaras Sutcu Imam University; 🇹🇷 Kahramanmaras, Onikisubat, Turkey