NCT01583751

Brief Summary

This study examines performing pilonidal sinus surgery minimal invasively with videoendoscopic approach.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Mar 2011

Typical duration for phase_1

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2011

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

July 21, 2011

Completed
9 months until next milestone

First Posted

Study publicly available on registry

April 24, 2012

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2013

Completed
Last Updated

April 24, 2012

Status Verified

April 1, 2012

Enrollment Period

2 years

First QC Date

July 21, 2011

Last Update Submit

April 23, 2012

Conditions

RecurrencePostoperative Complication

Keywords

pilonidal sinusnew techniquevideoendoscopic

Outcome Measures

Primary Outcomes (1)

  • recurrence rates

    primary outcome measure of effectivity of pilonidal sinus surgery is recurrence rates.

    six months

Secondary Outcomes (1)

  • postoperative complications, wound healing

    1 month

Study Arms (1)

control

EXPERIMENTAL

excision and primer repair surgical technique will be perform

Procedure: videoendoscopic resection of pilonidal sinus

Interventions

videoendoscopic resection of pilonidal sinusPROCEDURE

Resection of pilonidal sinus tissue with videoendoscopic approach.

Also known as: Active Comparator: Control: Group 1, Procedure/Surgery: Videoendoscopic: Group-2
control

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • symptomatic pilonidal sinus disease
  • primer pilonidal sinus disease
  • noncomplicated pilonidal sinus disease

You may not qualify if:

  • Asymptomatic pilonidal sinus disease
  • Recurrence pilonidal sinus disease
  • complicated pilonidal sinus disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bezmialem Vakif University

Istanbul, 34545, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

RecurrencePostoperative ComplicationsPilonidal Sinus

Condition Hierarchy (Ancestors)

Disease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsCystsNeoplasms

Study Officials

  • erhan aysan, assoc prof

    Bezmialem Vakif University

    STUDY DIRECTOR

Central Study Contacts

erhan aysan, assoc prof

CONTACT

+904531700dr@webcerrah.com

adnan yukel, prof

CONTACT

+904531700ayuksel@bezmialem.edu.tr

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assoc Prof

Study Record Dates

First Submitted

July 21, 2011

First Posted

April 24, 2012

Study Start

March 1, 2011

Primary Completion

March 1, 2013

Study Completion

March 1, 2013

Last Updated

April 24, 2012

Record last verified: 2012-04

Locations

TU(1)