NCT02621879

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2012

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2012

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2015

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

December 2, 2015

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 4, 2015

Completed
28 days until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2016

Completed
Last Updated

March 16, 2016

Status Verified

March 1, 2016

Enrollment Period

3 years

First QC Date

December 2, 2015

Last Update Submit

March 14, 2016

Conditions

Pilonidal Sinus

Outcome Measures

Primary Outcomes (1)

  • Incidence of recurrence

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

    18 months

Secondary Outcomes (1)

  • Incidence of complications

    18 months

Study Arms (1)

Bilateral Gluteal Advancement Flap

EXPERIMENTAL

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

Procedure: Bilateral Gluteal Advancement Flap

Interventions

Bilateral Gluteal Advancement FlapPROCEDURE

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.

Bilateral Gluteal Advancement Flap

Eligibility Criteria

Age16 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • Patients aging less than 16 years.
  • Patients unfit for anesthesia.
  • Patients with primary pilonidal disease.
  • Patients with acute pilonidal abscess or active infection.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mansoura university hospital

Al Mansurah, Dakahlia Governorate, Egypt

Location

MeSH Terms

Conditions

Pilonidal Sinus

Condition Hierarchy (Ancestors)

CystsNeoplasms

Study Officials

  • Sameh H Emile, M.D

    Mansoura Univesity

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer of general surgery

Study Record Dates

First Submitted

December 2, 2015

First Posted

December 4, 2015

Study Start

March 1, 2012

Primary Completion

March 1, 2015

Study Completion

January 1, 2016

Last Updated

March 16, 2016

Record last verified: 2016-03

Locations

EG(1)