Clinical Trials Directory

Trials / Completed

CompletedNCT04572919

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

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
Phase
N/A
Study type
Interventional
Enrollment
137 (actual)
Sponsor
Zagazig University · Other Government
Sex
All
Age
18 Years – 60 Years
Healthy volunteers
Not accepted

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 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

Interventions

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

Timeline

Start date
2017-02-01
Primary completion
2019-08-31
Completion
2019-08-31
First posted
2020-10-01
Last updated
2020-10-01

Locations

1 site across 1 country: Egypt

Source: ClinicalTrials.gov record NCT04572919. Inclusion in this directory is not an endorsement.