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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04572919
Other study ID # MIFarid
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date February 1, 2017
Est. completion date August 31, 2019

Study information

Verified date September 2020
Source Zagazig University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Description:

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.


Recruitment information / eligibility

Status Completed
Enrollment 137
Est. completion date August 31, 2019
Est. primary completion date August 31, 2019
Accepts healthy volunteers No
Gender All
Age group 18 Years to 60 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
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

Locations

Country Name City State
Egypt Zagazig University Hospitals Zagazig Sharkia

Sponsors (1)

Lead Sponsor Collaborator
Zagazig University

Country where clinical trial is conducted

Egypt, 

Outcome

Type Measure Description Time frame Safety issue
Primary recurrence number of patients recurrence 12 - 36 months
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