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

Not Applicable

Completed

• Conditions: Pilonidal Sinus
• Interventions: Procedure: classic Limberg flap; Procedure: lateral advancement flap

• Registration Number: NCT04572919
• Lead Sponsor: Zagazig University

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 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.

Study Timeline

• Study Start: 2017-02-01
• Primary Completion: 2019-08-31
• Study Completion: 2019-08-31
• Status Verified: 2020-09
• Study First Submitted: 2020-09-19
• Study First Submitted QC: 2020-09-26
• Last Update Submitted: 2020-09-26
• Study First Posted: 2020-10-01
• Last Update Posted: 2020-10-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 137

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
group B	classic Limberg flap	Patients were randomly assigned to undergo classic Limberg flap
group A	lateral advancement flap	Patients were randomly assigned to undergo lateral advancement flap

Primary Outcome Measures

Name	Time	Method
recurrence	12 - 36 months	number of patients recurrence

Trial Locations

Locations (1)

Zagazig University Hospitals; 🇪🇬 Zagazig, Sharkia, Egypt