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Completed

NCT Number: NCT02621879

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

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

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Key information

Conditions

Pilonidal Sinus Cysts Neoplasms

Age range

16 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mansoura university hospital

Al Mansurah, Dakahlia Governorate, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Bilateral Gluteal Advancement Flap

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.

Primary outcomes

  1. Incidence of recurrence

    Time frame: 18 months

    Number of patients who presents with recurrent pilonidal sinus within the follow up period

Secondary outcomes

  1. Incidence of complications

    Time frame: 18 months

    Number of patients who present with wound infection or other morbidity after the operation

Sponsors and collaborators

Lead sponsor

Mansoura University

Other

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2015
Study completion
2016
First posted
Dec 4, 2015
Registry last updated
Mar 16, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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