Videoendoscopic Pilonidal Sinus Surgery

Recurrence Clinical Trial

— videosinus  

Official title:

Videoendoscopic Pilonidal Sinus Surgery. A New Technique

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01583751
• Other study ID #: pilonidal1
• Status: Recruiting
• Phase: Phase 1
• First received: July 21, 2011
• Last updated: April 23, 2012
• Start date: March 2011
• Est. completion date: March 2013

Study information

• Verified date: April 2012
• Source: SB Istanbul Education and Research Hospital
• Contact: erhan aysan, assoc prof
• Phone: +904531700
• Email: dr[@]webcerrah.com
• Is FDA regulated: No
• Health authority: Turkey: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: March 2013
• Est. primary completion date: March 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

Inclusion Criteria:

• symptomatic pilonidal sinus disease

• primer pilonidal sinus disease

• noncomplicated pilonidal sinus disease

Exclusion Criteria:

• Asymptomatic pilonidal sinus disease

• Recurrence pilonidal sinus disease

• complicated pilonidal sinus disease

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Pilonidal Sinus
• Postoperative Complication
• Postoperative Complications
• Recurrence

Intervention

Procedure:
• videoendoscopic resection of pilonidal sinus
Resection of pilonidal sinus tissue with videoendoscopic approach.

Locations

Country	Name	City	State
Turkey	Bezmialem Vakif University	Istanbul

Sponsors (1)

Lead Sponsor	Collaborator
SB Istanbul Education and Research Hospital

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	recurrence rates	primary outcome measure of effectivity of pilonidal sinus surgery is recurrence rates.	six months	Yes
Secondary	postoperative complications, wound healing	Postoperative complications such as bleeding and infection are important outcome measurements. Wound healing time is the other important one.	1 month	Yes