Videoendoscopic Pilonidal Sinus Surgery | NCT01583751

Studies
Videoendoscopic Pilonidal Sinus Surgery

NCT01583751

Sponsor

SB Istanbul Education and Research Hospital

Status

Unknown status

Last Update Posted

Apr 24, 2012Estimated

Enrollment

60Estimated

Phase

Phase 1

Conditions

Recurrence
Postoperative Complication

Interventions

videoendoscopic resection of pilonidal sinus

Countries

Turkey (Türkiye)

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2012

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 2011

Primary Completion Date

Mar 2013Estimated

Completion Date

Mar 2013Estimated

First Submitted Date

Jul 21, 2011

First Submission Date that Met QC Criteria

Apr 23, 2012

First Posted Date

Apr 24, 2012Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 23, 2012

Last Update Posted Date

Apr 24, 2012Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Erhan Aysan, Assoc Prof, SB Istanbul Education and Research HospitalPrincipal Investigator

Lead Sponsor

SB Istanbul Education and Research HospitalOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

60Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
control	Experimental	excision and primer repair surgical technique will be perform	Procedure: videoendoscopic resection of pilonidal sinus

Interventions

Name	Type	Description	Arm Group Labels	Other Names
videoendoscopic resection of pilonidal sinus	Procedure	Resection of pilonidal sinus tissue with videoendoscopic approach.	control

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
recurrence rates	primary outcome measure of effectivity of pilonidal sinus surgery is recurrence rates.	six months

Secondary Outcomes

Measure	Description	Time Frame
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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

60 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
erhan aysan, assoc prof	Contact	+904531700		dr@webcerrah.com
adnan yukel, prof	Contact	+904531700		ayuksel@bezmialem.edu.tr

Overall Officials

Name	Affiliation	Role
erhan aysan, assoc prof	Bezmialem Vakif University	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Bezmialem Vakif University	Recruiting	Istanbul		34545	Turkey (Türkiye)

Condition Browse Module

MeSH Terms

ID	Term
D012008	Recurrence
D011183	Postoperative Complications
D010864	Pilonidal Sinus

Ancestor Terms

ID	Term
D020969	Disease Attributes
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms
D003560	Cysts

Browse Leaves

Not provided

Browse Branches

Not provided