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OpenTrials
Completed

NCT Number: NCT04572919

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

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.

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Key information

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Zagazig University Hospitals

Zagazig, Sharqia Province, 44519, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

lateral advancement flap

Procedure

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

classic Limberg flap

Procedure

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

Primary outcomes

  1. recurrence

    Time frame: 12 - 36 months

    number of patients recurrence

Sponsors and collaborators

Lead sponsor

Zagazig University

Other Gov

Registry information

Official study title

Lateral Advancement Adipo-Fascio-Cutaneous Flap Versus Classic Limberg Flap in The Treatment Of Non-Complicated Pilonidal Sinus: A Prospective Randomized Controlled Trial

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Oct 1, 2020
Registry last updated
Oct 1, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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