Back to resultsBilateral Gluteal Fascio-myo-cutaneous Flap in Treatment of Recurrent Pilonidal Disease
Primary Purpose
Pilonidal Sinus
Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Bilateral Gluteal Advancement Flap
Sponsored by
About this trial
This is an interventional treatment trial for Pilonidal Sinus
Eligibility Criteria
Inclusion Criteria:
- Patients with recurrent sacrococcygeal pilonidal disease aging more than 16 years with single or multiple pits were included in the study.
- Patients included presented with recurrence of pilonidal disease at least six months after the first operation.
Exclusion Criteria:
- Patients aging less than 16 years.
- Patients unfit for anesthesia.
- Patients with primary pilonidal disease.
- Patients with acute pilonidal abscess or active infection.
Sites / Locations
- Mansoura university hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Bilateral Gluteal Advancement Flap
Arm Description
Advancement of both gluteal muscles to the midline after release incisions in their fascia.
Outcomes
Primary Outcome Measures
Incidence of recurrence
Number of patients who presents with recurrent pilonidal sinus within the follow up period
Secondary Outcome Measures
Incidence of complications
Number of patients who present with wound infection or other morbidity after the operation
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02621879
Brief Title
Bilateral Gluteal Fascio-myo-cutaneous Flap in Treatment of Recurrent Pilonidal Disease
Official Title
Bilateral Gluteal Fascio-myo-cutaneous Advancement Flap in Treatment of Recurrent Sacrococcygeal Pilonidal Disease
Study Type
Interventional
2. Study Status
Record Verification Date
March 2016
Overall Recruitment Status
Completed
Study Start Date
March 2012 (undefined)
Primary Completion Date
March 2015 (Actual)
Study Completion Date
January 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mansoura University
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Bilateral Gluteal Fascio-myo-cutaneous Advancement Flap is a modified technique used in Treatment of Recurrent Sacrococcygeal Pilonidal sinus
Detailed Description
Patients with recurrent pilonidal sinus disease are recruited to undergo Bilateral Gluteal Fascio-myo-cutaneous Advancement Flap technique under spinal anesthesia in order to prevent recurrence.
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
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
40 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Bilateral Gluteal Advancement Flap
Arm Type
Experimental
Arm Description
Advancement of both gluteal muscles to the midline after release incisions in their fascia.
Intervention Type
Procedure
Intervention Name(s)
Bilateral Gluteal Advancement Flap
Intervention Description
Dissection of both gluteus maximus muscles from their origin in the sacrum, advancement of both muscles is conducted to the midline after creating release incisions in their fascia.
Primary Outcome Measure Information:
Title
Incidence of recurrence
Description
Number of patients who presents with recurrent pilonidal sinus within the follow up period
Time Frame
18 months
Secondary Outcome Measure Information:
Title
Incidence of complications
Description
Number of patients who present with wound infection or other morbidity after the operation
Time Frame
18 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
16 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients with recurrent sacrococcygeal pilonidal disease aging more than 16 years with single or multiple pits were included in the study.
Patients included presented with recurrence of pilonidal disease at least six months after the first operation.
Exclusion Criteria:
Patients aging less than 16 years.
Patients unfit for anesthesia.
Patients with primary pilonidal disease.
Patients with acute pilonidal abscess or active infection.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sameh H Emile, M.D
Organizational Affiliation
Mansoura Univesity
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mansoura university hospital
City
Mansoura
State/Province
Dakahlia
Country
Egypt
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Bilateral Gluteal Fascio-myo-cutaneous Flap in Treatment of Recurrent Pilonidal Disease
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