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

NCT ID: NCT02621879

Last Updated: 2016-03-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-03-31

Study Completion Date

2016-01-31

Brief Summary

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

Detailed Description

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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.

Conditions

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Pilonidal Sinus

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Bilateral Gluteal Advancement Flap

Advancement of both gluteal muscles to the midline after release incisions in their fascia.

Group Type EXPERIMENTAL

Bilateral Gluteal Advancement Flap

Intervention Type PROCEDURE

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.

Interventions

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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.

Intervention Type PROCEDURE

Eligibility Criteria

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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.
Minimum Eligible Age

16 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Mansoura University

OTHER

Sponsor Role lead

Responsible Party

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Sameh Emile

Lecturer of general surgery

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Sameh H Emile, M.D

Role: PRINCIPAL_INVESTIGATOR

Mansoura Univesity

Locations

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Mansoura university hospital

Al Mansurah, Dakahlia Governorate, Egypt

Site Status

Countries

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Egypt

Other Identifiers

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mansourau27

Identifier Type: -

Identifier Source: org_study_id

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