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

Pilonidal Sinus Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04572919
• Other study ID #: MIFarid
• Status: Completed
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Pilonidal Sinus

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