Videoendoscopic Pilonidal Sinus Surgery

NCT ID: NCT01583751

Last Updated: 2012-04-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE1

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-03-31

Study Completion Date

2013-03-31

Brief Summary

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

Detailed Description

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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.

Conditions

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Recurrence Postoperative Complication

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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control

excision and primer repair surgical technique will be perform

Group Type EXPERIMENTAL

videoendoscopic resection of pilonidal sinus

Intervention Type PROCEDURE

Resection of pilonidal sinus tissue with videoendoscopic approach.

Interventions

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videoendoscopic resection of pilonidal sinus

Resection of pilonidal sinus tissue with videoendoscopic approach.

Intervention Type PROCEDURE

Other Intervention Names

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Active Comparator: Control: Group 1 Procedure/Surgery: Videoendoscopic: Group-2

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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SB Istanbul Education and Research Hospital

OTHER

Sponsor Role lead

Responsible Party

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Erhan Aysan

Assoc Prof

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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erhan aysan, assoc prof

Role: STUDY_DIRECTOR

Bezmialem Vakif University

Locations

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Bezmialem Vakif University

Istanbul, , Turkey (Türkiye)

Site Status RECRUITING

Countries

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Turkey (Türkiye)

Central Contacts

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erhan aysan, assoc prof

Role: CONTACT

+904531700

adnan yukel, prof

Role: CONTACT

+904531700

Facility Contacts

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adnan yuksel, Prof

Role: primary

+902124531700

Other Identifiers

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pilonidal1

Identifier Type: -

Identifier Source: org_study_id

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