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

NCT04572919 | Completed

• 1 other identifier: MIFarid
• Study Type: interventional
• Target: 137
• Locations: 1 country
• Sites: 1

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.

Conditions

Pilonidal Sinus

Outcome Measures

Primary Outcomes (1)

• recurrence

  number of patients recurrence

  12 - 36 months

Study Arms (2)

group A

ACTIVE COMPARATOR

Patients were randomly assigned to undergo lateral advancement flap

Procedure: lateral advancement flap

group B

ACTIVE COMPARATOR

Patients were randomly assigned to undergo classic Limberg flap

Procedure: classic Limberg flap

Interventions

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

group A

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

group B

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• patients with non-complicated pilonidal sinus
• whose ages ranged from 18 to 60years

You may not qualify if:

• 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

Sponsors & Collaborators

• Zagazig University: lead

Study Sites (1)

Zagazig University Hospitals

Zagazig, Sharqia Province, 44519, Egypt

Location

MeSH Terms

Conditions

Pilonidal Sinus

Condition Hierarchy (Ancestors)

Cysts; Neoplasms

Study Officials

• mohamed farid, MD

  zagazig university hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: associate professor of general surgery

Study Record Dates

• First Submitted: September 19, 2020
• First Posted: October 1, 2020
• Study Start: February 1, 2017
• Primary Completion: August 31, 2019
• Study Completion: August 31, 2019
• Last Updated: October 1, 2020

Record last verified: 2020-09

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)