Bilateral Gluteal Fascio-myo-cutaneous Flap in Treatment of Recurrent Pilonidal Disease

Pilonidal Sinus Clinical Trial

Official title:

Bilateral Gluteal Fascio-myo-cutaneous Advancement Flap in Treatment of Recurrent Sacrococcygeal Pilonidal Disease

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02621879
• Other study ID #: mansourau27
• Status: Completed
• Phase: N/A
• First received: December 2, 2015
• Last updated: March 14, 2016
• Start date: March 2012
• Est. completion date: January 2016

Study information

• Verified date: March 2016
• Source: Mansoura University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Egypt: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

Bilateral Gluteal Fascio-myo-cutaneous Advancement Flap is a modified technique used in Treatment of Recurrent Sacrococcygeal Pilonidal sinus

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: January 2016
• Est. primary completion date: March 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 16 Years to 70 Years

Eligibility

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.

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Pilonidal Sinus

Intervention

Procedure:
• Bilateral Gluteal Advancement Flap
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.

Locations

Country	Name	City	State
Egypt	Mansoura university hospital	Mansoura	Dakahlia

Sponsors (1)

Lead Sponsor	Collaborator
Mansoura University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of recurrence	Number of patients who presents with recurrent pilonidal sinus within the follow up period	18 months	No
Secondary	Incidence of complications	Number of patients who present with wound infection or other morbidity after the operation	18 months	No