Lateral Advancement Flap Versus Classic Limberg Flap in The Treatment Of NonComplicated Pilonidal Sinus
Primary Purpose
Pilonidal Sinus
Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
lateral advancement flap
classic Limberg flap
Sponsored by
About this trial
This is an interventional treatment trial for Pilonidal Sinus
Eligibility Criteria
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
Sites / Locations
- Zagazig University Hospitals
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
group A
group B
Arm Description
Patients were randomly assigned to undergo lateral advancement flap
Patients were randomly assigned to undergo classic Limberg flap
Outcomes
Primary Outcome Measures
recurrence
number of patients recurrence
Secondary Outcome Measures
Full Information
NCT ID
NCT04572919
First Posted
September 19, 2020
Last Updated
September 26, 2020
Sponsor
Zagazig University
1. Study Identification
Unique Protocol Identification Number
NCT04572919
Brief Title
Lateral Advancement Flap Versus Classic Limberg Flap in The Treatment Of NonComplicated Pilonidal Sinus
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
Study Type
Interventional
2. Study Status
Record Verification Date
September 2020
Overall Recruitment Status
Completed
Study Start Date
February 1, 2017 (Actual)
Primary Completion Date
August 31, 2019 (Actual)
Study Completion Date
August 31, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Zagazig University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pilonidal Sinus
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
137 (Actual)
8. Arms, Groups, and Interventions
Arm Title
group A
Arm Type
Active Comparator
Arm Description
Patients were randomly assigned to undergo lateral advancement flap
Arm Title
group B
Arm Type
Active Comparator
Arm Description
Patients were randomly assigned to undergo classic Limberg flap
Intervention Type
Procedure
Intervention Name(s)
lateral advancement flap
Intervention Description
Patients were randomly assigned to undergo either lateral advancement flap or classic Limberg flap for treatment of non-complicated pilonidal sinus
Intervention Type
Procedure
Intervention Name(s)
classic Limberg flap
Intervention Description
Patients were randomly assigned to undergo either lateral advancement flap or classic Limberg flap for treatment of non-complicated pilonidal sinus
Primary Outcome Measure Information:
Title
recurrence
Description
number of patients recurrence
Time Frame
12 - 36 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
mohamed farid, MD
Organizational Affiliation
zagazig university hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Zagazig University Hospitals
City
Zagazig
State/Province
Sharkia
ZIP/Postal Code
44519
Country
Egypt
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
the Study Protocol and the Clinical Study Report are planned to be shared
Learn more about this trial
Lateral Advancement Flap Versus Classic Limberg Flap in The Treatment Of NonComplicated Pilonidal Sinus
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