NCT00716937

Brief Summary

Recurrence, Complications, Work-off date, Healing time and Patients Willingness in Karydakis Technique for Treatment of Sacrococcygeal Pilonidal Sinus versus Healing by Secondary Intention (EHSI) Technique in Imam Khomeini Hospital from 2008 to 2011

Trial Health

87
On Track

Trial Health Score

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

Enrollment
321

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Sep 2007

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

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

September 1, 2007

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

July 14, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 16, 2008

Completed
5.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2014

Completed
Last Updated

December 16, 2014

Status Verified

December 1, 2014

Enrollment Period

6.5 years

First QC Date

July 14, 2008

Last Update Submit

December 15, 2014

Conditions

Pilonidal SinusPilonidal Cyst

Keywords

pilonidal sinuskarydakislaying open

Outcome Measures

Primary Outcomes (1)

  • Recurrence

    1 year after surgery

Secondary Outcomes (1)

  • Work off date, Healing Time

    up to 1 Year after surgery

Study Arms (2)

1

EXPERIMENTAL

Excision of the cyst and Karydakis flap

Procedure: karydakis flap

2

EXPERIMENTAL

Excision of the cyst and laying open

Procedure: karydakis flapProcedure: laying open

Interventions

karydakis flapPROCEDURE

Karydakis flap is a type of primary repair of the wound, after complete excision of sacral pilonidal cyst with 2 characteristics 1)lateralization of final scar 2)flattening of natal cleft

Also known as: lateralization, primary repair
12
laying openPROCEDURE

laying open the site of excision of sinus or cyst without any flap

2

Eligibility Criteria

Age10 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • all types of pilonidal sinus or cyst

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tehran University of medical Sciences, Deputy of Research

Tehran, Tehran Province, 23, Iran

Location

MeSH Terms

Conditions

Pilonidal Sinus

Condition Hierarchy (Ancestors)

CystsNeoplasms

Study Officials

  • Amir Keshvari, Assoc. Prof.

    Tehran University of Medical Sciences

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 14, 2008

First Posted

July 16, 2008

Study Start

September 1, 2007

Primary Completion

March 1, 2014

Study Completion

March 1, 2014

Last Updated

December 16, 2014

Record last verified: 2014-12

Locations

IR(1)