Viewing Study NCT04572919



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Last Modification Date: 2024-10-26 @ 1:46 PM
Study NCT ID: NCT04572919
Status: COMPLETED
Last Update Posted: 2020-10-01
First Post: 2020-09-19

Brief Title: Lateral Advancement Flap Versus Classic Limberg Flap in The Treatment Of NonComplicated Pilonidal Sinus
Sponsor: Zagazig University
Organization: Zagazig University

Study Overview

Official Title: Lateral Advancement Adipo-Fascio-Cutaneous Flap Versus Classic Limberg Flap in The Treatment Of Non-Complicated Pilonidal Sinus A Prospective Randomized Controlled Trial
Status: COMPLETED
Status Verified Date: 2020-09
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
Brief 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
Detailed Description: Hodges was the first to use the term pilonidal which was derived from the Latin pilushair and nidusnest 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

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: False
Is a FDA Regulated Device?: False
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None