Lateral Advancement Flap Versus Classic Limberg Flap in The Treatment Of NonComplicated Pilonidal Sinus
NCT ID: NCT04572919
Last Updated: 2020-10-01
Study Results
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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COMPLETED
NA
137 participants
INTERVENTIONAL
2017-02-01
2019-08-31
Brief Summary
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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.
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Detailed Description
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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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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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group A
Patients were randomly assigned to undergo lateral advancement flap
lateral advancement flap
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
classic Limberg flap
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
classic Limberg flap
Patients were randomly assigned to undergo either lateral advancement flap or classic Limberg flap for treatment of non-complicated pilonidal sinus
Eligibility Criteria
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Inclusion Criteria
* whose ages ranged from 18 to 60years
Exclusion Criteria
* 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
18 Years
60 Years
ALL
No
Sponsors
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Zagazig University
OTHER_GOV
Responsible Party
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Mohamed I Farid
associate professor of general surgery
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
Countries
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Other Identifiers
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MIFarid
Identifier Type: -
Identifier Source: org_study_id
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