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

NCT ID: NCT04217824

Last Updated: 2020-07-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-05-22

Study Completion Date

2021-05-22

Brief Summary

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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

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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.

Conditions

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Pilonidal Sinus Postoperative Complications

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

pilonidal sinus excision

Intervention Type PROCEDURE

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

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.

Group Type ACTIVE_COMPARATOR

pilonidal sinus excision

Intervention Type PROCEDURE

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

Interventions

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pilonidal sinus excision

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

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Pilonidal sinus disease

Exclusion Criteria

* Other disease than pilonidal sinus disease.
Minimum Eligible Age

10 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Kahramanmaras Sutcu Imam University

OTHER

Sponsor Role lead

Responsible Party

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Ahmet Gökhan Güler

assistant professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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ahmet gökhan güler

Role: PRINCIPAL_INVESTIGATOR

kahramanmarasSUI

Locations

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Kahramanmaras Sutcu Imam University

Kahramanmaraş, Onikisubat, Turkey (Türkiye)

Site Status RECRUITING

Countries

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Turkey (Türkiye)

Central Contacts

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ahmet gokhan guler

Role: CONTACT

+905057702633

ali erdal karakaya

Role: CONTACT

+905326313017

Facility Contacts

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ahmet gökhan güler

Role: primary

+905057702633

Other Identifiers

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2019/04-02

Identifier Type: -

Identifier Source: org_study_id

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