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Status unknownNCT01583751videosinusUpdated Apr 24, 2012

Videoendoscopic Pilonidal Sinus Surgery

A Phase 1 interventional study of videoendoscopic resection of pilonidal sinus in Recurrence and Postoperative Complication, sponsored by SB Istanbul Education and Research Hospital. Status unknown at 1 site in Turkey (Türkiye). Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2012-04-24.

Sponsored by SB Istanbul Education and Research Hospital · Phase 1, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Apr 2012), so the status shown — last known as Recruiting — may be out of date.
Phase
Phase 1
Study type
Interventional
Enrollment
60
Allocation
Not applicable
Ages
18 Years to 60 Years
Sex
All
01

Study summary

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

Read the detailed description

Lots of surgical techniques are performing on pilonidal sinus disease treatment. Lately large flap techniques are popular but causing anatomical distortions and bad cosmesis. In this new approach the investigators concluded that two 1cm diameter holes are enough to surgical treatment. One hole is for videoendoscopic camera and the other one for grasper to extract piluses and granulation tissues.

02

Conditions studied

  • Recurrence
  • Postoperative Complication

Keywords

  • pilonidal sinus
  • new technique
  • videoendoscopic
03

In context

Recurrence

4,349 studies on the registry are indexed under Recurrence; 1,004 are open to participants now.

This study's planned enrollment of 60 is above the median of 50 across 3,429 interventional studies indexed under Recurrence.

Browse Recurrence studies →

Lead sponsor

SB Istanbul Education and Research Hospital is the lead sponsor of 20 studies on the registry; 3 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • Asymptomatic pilonidal sinus disease
  • Recurrence pilonidal sinus disease
  • complicated pilonidal sinus disease
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
Single (Participant)
Enrollment
60 participants (estimated)

Study arms

  • Experimental
    control

    excision and primer repair surgical technique will be perform

    Procedure: videoendoscopic resection of pilonidal sinus

Interventions

  • Procedurevideoendoscopic resection of pilonidal sinus

    Resection of pilonidal sinus tissue with videoendoscopic approach.

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

06

What researchers measure

Primary outcomes

  1. recurrence rates

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

    Time frame: six months

Secondary outcomes

  1. postoperative complications, wound healing

    Postoperative complications such as bleeding and infection are important outcome measurements. Wound healing time is the other important one.

    Time frame: 1 month

07

Study locations

1 of 1 sites recruiting
  • Bezmialem Vakif University
    Istanbul, 34545, Turkey (Türkiye)
    • adnan yuksel, Prof · Contact · ayuksel@bezmialem.edu.tr · +902124531700
    • erhan aysan, assoc. prof. · Principal investigator
    • mahmut muslumanoglu, Prof · Principal investigator
    Recruiting
08

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Mar 2011, a primary completion of Mar 2013 and a completion of Mar 2013. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
Jul 21, 2011
First posted
Apr 24, 2012
Start
Mar 2011
Primary completionEst.
Mar 2013
CompletionEst.
Mar 2013
Last update
Apr 24, 2012
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Apr 24, 2012, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01583751
Lead sponsor
SB Istanbul Education and Research Hospital
Responsible party
Erhan Aysan (Assoc Prof, SB Istanbul Education and Research Hospital) — Principal investigator
First posted
Apr 24, 2012
Start date
Mar 2011
Primary completion
Mar 2013 (estimated)
Completion
Mar 2013 (estimated)
Last update
Apr 24, 2012

Study contacts

erhan aysan, assoc prof
Contact
dr@webcerrah.com
+904531700
adnan yukel, prof
Contact
ayuksel@bezmialem.edu.tr
+904531700
erhan aysan, assoc prof
study director · Bezmialem Vakif University

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Apr 2012. You cannot join it, but the record below documents what was studied.

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Discussion

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