Lateral Advancement Flap Versus Classic Limberg Flap in The Treatment Of NonComplicated Pilonidal Sinus

NCT ID: NCT04572919

Last Updated: 2020-10-01

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

COMPLETED

Clinical Phase

NA

Total Enrollment

137 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-02-01

Study Completion Date

2019-08-31

Brief Summary

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Background The flaps closure including natal cleft obliteration and eccentric closure are becoming more popular due to their lower rate of recurrence including both the lateral advancement adipo-fascio-cutaneous flap and the classic limberg flap.

Objective This study was aim to compare the results of the surgery for non-complicated pilonidal sinus with the lateral advancement adipo-fascio-cutaneous flap versus the classic Limberg flap.

Patients and methods This study was a prospective randomized controlled, and was conducted on patients with non-complicated pilonidal sinus attending Zagazig University Hospitals, Egypt during the period from February 2017 to August 2019. Patients were randomly assigned to undergo either lateral advancement flap or classic Limberg flap groups. The follow-up period ranged from 12 to 36 months. Patient satisfaction, complications and recurrence rates were analyzed and compared.

Detailed Description

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Hodges was the first to use the term "pilonidal" (which was derived from the Latin pilus=hair and nidus=nest) in 1988.

The pilonidal disease is usually predisposed by the presence of a deep natal cleft containing a lot of hairs within it, which is also supplies a good environment for maceration, sweating, hairs penetration, and bacterial contamination . A lot of surgical treatment techniques are described for pilonidal sinus disease as simple excision and packing, excision with primary midline closure, marsupialization and eccentric closure by different types of flaps.

Though no surgical technique has been widely accepted, but the flaps closure including natal cleft obliteration and eccentric closure are becoming more popular due to their lower rate of recurrence.

Although the off-midline approach seems optimal for closure, the standard off-midline surgery has not yet been concluded.

According to our best knowledge, no randomized study has yet compared the lateral advancement adipo-fascio-cutaneous flap and the classic Limberg flap. Therefore, the aim of the present study was to compare in a randomized controlled trial the short-term results of the surgical treatment of non-complicated pilonidal sinus with the lateral advancement adipo-fascio-cutaneous flap versus the classic Limberg flap.

Conditions

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Pilonidal Sinus

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Caregivers

Study Groups

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group A

Patients were randomly assigned to undergo lateral advancement flap

Group Type ACTIVE_COMPARATOR

lateral advancement flap

Intervention Type PROCEDURE

Patients were randomly assigned to undergo either lateral advancement flap or classic Limberg flap for treatment of non-complicated pilonidal sinus

group B

Patients were randomly assigned to undergo classic Limberg flap

Group Type ACTIVE_COMPARATOR

classic Limberg flap

Intervention Type PROCEDURE

Patients were randomly assigned to undergo either lateral advancement flap or classic Limberg flap for treatment of non-complicated pilonidal sinus

Interventions

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lateral advancement flap

Patients were randomly assigned to undergo either lateral advancement flap or classic Limberg flap for treatment of non-complicated pilonidal sinus

Intervention Type PROCEDURE

classic Limberg flap

Patients were randomly assigned to undergo either lateral advancement flap or classic Limberg flap for treatment of non-complicated pilonidal sinus

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* patients with non-complicated pilonidal sinus
* whose ages ranged from 18 to 60years

Exclusion Criteria

* elderly patients with comorbid diseases
* scars from a previous pilonidal surgery or recurrent cases
* abscess presentations
* diabetes mellitus, immunodeficiency, or other co-morbidity
* American Society of Anesthesiologists physical status classification grade III-IV
* age \< 18years or \> 60 years
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Zagazig University

OTHER_GOV

Sponsor Role lead

Responsible Party

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Mohamed I Farid

associate professor of general surgery

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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mohamed farid, MD

Role: PRINCIPAL_INVESTIGATOR

zagazig university hospital

Locations

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Zagazig University Hospitals

Zagazig, Sharqia Province, Egypt

Site Status

Countries

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Egypt

Other Identifiers

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MIFarid

Identifier Type: -

Identifier Source: org_study_id

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