Reduction Dead Space Volume With Karydakis Modification
Primary Purpose
PILONIDAL SINUS
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
A new surgical technique
Sponsored by
About this trial
This is an interventional treatment trial for PILONIDAL SINUS focused on measuring karydakis modification, pilonidal sinus, complication
Eligibility Criteria
Inclusion Criteria:
- Patients older than 18 years
- patients who accept the procedure
- chronic p.sinüs disease
Exclusion Criteria:
- previous sinüs surgery
- active infection
- patients who did not accept the procedure
- patients under age of 18.
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
modified Karydakis,surgical technique
Arm Description
a new surgical technique(modified Karydakis) to be compared with standard Karydakis
Outcomes
Primary Outcome Measures
Effects of reducing the dead space volume (Change in dead space volume) with a modification in The Karydakis Method in sacrococcygeal pilonidal sinus surgery
OUTCOME MEASURE:
Extracted sinus volume
The number of patients with complications
Delayed wound healing
seroma
hematoma formation
wound infection
Secondary Outcome Measures
Full Information
NCT ID
NCT02574936
First Posted
October 8, 2015
Last Updated
October 13, 2015
Sponsor
Siverek Devlet Hastanesi
Collaborators
Harran University
1. Study Identification
Unique Protocol Identification Number
NCT02574936
Brief Title
Reduction Dead Space Volume With Karydakis Modification
Official Title
Effects of Reduction Dead Space Volume With Karydakis Modification
Study Type
Interventional
2. Study Status
Record Verification Date
October 2015
Overall Recruitment Status
Completed
Study Start Date
January 2014 (undefined)
Primary Completion Date
August 2015 (Actual)
Study Completion Date
September 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Siverek Devlet Hastanesi
Collaborators
Harran University
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The purpose of this study is to reduce the volume of dead space by a modification in kardakis flap procedure and consequently, to reduce the use of drains, wound drainage, seroma and hematoma formation, skin degradation and recurrence rates.
Detailed Description
The study was a pilot study of 80 patients. Excluding criteria were previous sinüs surgery, active infection, patients who did not accept the procedure and patients under age of 18. After excision of the sinüs volume was measured using a beaker. A flap extending across the cut (Karydakis) was prepared in medial edge of the wound, 1 cm deep and 2 to 3 cm to be towards the interior. Prepared flap was shifted to the medial and sutured to presacral fascia with vicryl 2/0. To reduce the volume of the dead space formed in the lateral, 5 mm skin was excised along the incision in the flap side. Skin was approximated with sutures in the form of intermittent, using 2/0 poliprolen. No drain used. All patients were discharged on postoperative day 1. Sutures were removed 2 weeks later. All patients for at least 6 months were followed for wound drainage, seroma and hematoma formation, separation of skin and and recurrence.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
PILONIDAL SINUS
Keywords
karydakis modification, pilonidal sinus, complication
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
80 (Actual)
8. Arms, Groups, and Interventions
Arm Title
modified Karydakis,surgical technique
Arm Type
Other
Arm Description
a new surgical technique(modified Karydakis) to be compared with standard Karydakis
Intervention Type
Procedure
Intervention Name(s)
A new surgical technique
Other Intervention Name(s)
Modified Karydakis
Intervention Description
Description of a new surgical technique in pilonidal sinüs surgery in order to reduce dead space volume.
A flap extending across the cut (Karydakis) is prepared in medial edge of the wound, 1 cm deep and 2 to 3 cm to be towards the interior. Prepared flap is shifted to the medial and sutured to presacral fascia with vicryl 2/0. To reduce the volume of the dead space formed in the lateral, 5 mm skin is excised along the incision in the flap side. Skin is approximated with sutures in the form of intermittent, using 2/0 poliprolen. No drain used
Primary Outcome Measure Information:
Title
Effects of reducing the dead space volume (Change in dead space volume) with a modification in The Karydakis Method in sacrococcygeal pilonidal sinus surgery
Description
OUTCOME MEASURE:
Extracted sinus volume
The number of patients with complications
Delayed wound healing
seroma
hematoma formation
wound infection
Time Frame
18 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
49 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients older than 18 years
patients who accept the procedure
chronic p.sinüs disease
Exclusion Criteria:
previous sinüs surgery
active infection
patients who did not accept the procedure
patients under age of 18.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ali Uzunköy
Organizational Affiliation
Harran University
Official's Role
Study Director
12. IPD Sharing Statement
Learn more about this trial
Reduction Dead Space Volume With Karydakis Modification
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