Effect of Costal Harvesting Technique on Postoperative Donor-site Morbidity: Does Muscle Sparing Technique Cause Less Postoperative Pain ? A Clinical Trial (COSTA)
Primary Purpose
Nasal Deformity, Revision Rhinoplasty, Autogenous Rib Graft
Status
Unknown status
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Harvesting rib cartilage
Sponsored by
About this trial
This is an interventional treatment trial for Nasal Deformity
Eligibility Criteria
Inclusion Criteria:
- Revision rhinoplasty
- when costal cartilage is harvested full-thickness
Exclusion Criteria:
- Fibromyalgia
- No consent
- When patient does not comply with follow-up
Sites / Locations
- Gaziosmanpasa Taksim Research and Education Hospital, Department of OtorhinolaryngologyRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Muscle-sparing
Muscle-cutting
Arm Description
Following skin incision with No.15 blade; all layers including the subcutaneous fat, muscle fascia and muscles covering the cartilage were passed with blunt dissection. Muscle fibers were dissected parallel to their positioning.
Following skin incision with No.15 blade; all layers including the subcutaneous fat, muscle fascia and muscles covering the cartilage were cut with Monopolar electrocautery at (25 watts).
Outcomes
Primary Outcome Measures
Change in Postoperative Pain
Postoperative pain and its change from baseline to 45th postoperative day will be evaluated with Visual Analogue Scale
Secondary Outcome Measures
Full Information
NCT ID
NCT02818634
First Posted
June 17, 2016
Last Updated
June 27, 2016
Sponsor
Gaziosmanpasa Research and Education Hospital
1. Study Identification
Unique Protocol Identification Number
NCT02818634
Brief Title
Effect of Costal Harvesting Technique on Postoperative Donor-site Morbidity: Does Muscle Sparing Technique Cause Less Postoperative Pain ? A Clinical Trial
Acronym
COSTA
Official Title
Effect of Costal Harvesting Technique on Postoperative Donor-site Morbidity: Does Muscle Sparing Technique Cause Less Postoperative Pain ? A Clinical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
June 2016
Overall Recruitment Status
Unknown status
Study Start Date
February 2016 (undefined)
Primary Completion Date
July 2016 (Anticipated)
Study Completion Date
August 2016 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Gaziosmanpasa Research and Education Hospital
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study was to investigate the effect of 'muscle sparing technique' while harvesting costal/rib cartilage on postoperative donor-site morbidity -namely postoperative pain. Although authors report 'muscle sparing technique' cause less pain its not investigated in an evidence-based-medicine perspective. Therefore the investigators are planning a controlled, prospective clinical trial to compare the conventional method and 'muscle sparing technique'.
Effect of Costal Harvesting Technique on Postoperative Donor-site Morbidity: Does Muscle Sparing Technique Cause Less Postoperative Pain ? A Clinical Trial
Detailed Description
Revision rhinoplasty patients requiring costal cartilage were enrolled in the study. All costal cartilage harvestings were full-thickness and they were carried out by a single-surgeon (Berke Ozucer). Patients were randomly assigned either to 'Conservative Muscle-cuttingHarvesting Technique' or 'Muscle-sparing Harvesting Technique'.
Surgical technique costal cartilage harvesting in both groups were identical expect this:
M-Cutting group : Following skin incision with No.15 blade; all layers including the subcutaneous fat, muscle fascia and muscles covering the cartilage were cut with Monopolar electrocautery at (25 watts).
M-Sparing group: : Following skin incision with No.15 blade; all layers including the subcutaneous fat, muscle fascia and muscles covering the cartilage were passed with blunt dissection. Muscle fibers were dissected parallel to their positioning.
Postoperative pain was evaluated with a Visual Analogue Scale. Participants were questioned regarding their donor-site pain and asked to score their pain 0 (minimum and 10 (maximum). Passive state and pain while active was evaluated separately. This evaluation was carried out at 6th postoperative hour, first, second, third postoperative-days, first postoperative week, on 15th ,30th and 45th day postoperatively. Also postoperative need for analgesics were also noted for the first three days.
Muscle-cutting and muscle-sparing groups were analysed for mean ± Standard deviation values. These values were compared statistically to assess whether muscle-sparing technique has a significant effect on reduced postoperative pain.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Nasal Deformity, Revision Rhinoplasty, Autogenous Rib Graft, Costal Cartilage, Harvesting
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Muscle-sparing
Arm Type
Active Comparator
Arm Description
Following skin incision with No.15 blade; all layers including the subcutaneous fat, muscle fascia and muscles covering the cartilage were passed with blunt dissection. Muscle fibers were dissected parallel to their positioning.
Arm Title
Muscle-cutting
Arm Type
Active Comparator
Arm Description
Following skin incision with No.15 blade; all layers including the subcutaneous fat, muscle fascia and muscles covering the cartilage were cut with Monopolar electrocautery at (25 watts).
Intervention Type
Procedure
Intervention Name(s)
Harvesting rib cartilage
Primary Outcome Measure Information:
Title
Change in Postoperative Pain
Description
Postoperative pain and its change from baseline to 45th postoperative day will be evaluated with Visual Analogue Scale
Time Frame
Postoperative first 45 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
17 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Revision rhinoplasty
when costal cartilage is harvested full-thickness
Exclusion Criteria:
Fibromyalgia
No consent
When patient does not comply with follow-up
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Berke Ozucer, MD
Phone
905309635939
Email
berkeozucer@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Mehmet E Dinc, MD
Phone
905065426492
Email
dremredinc@hotmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Berke Ozucer, MD
Organizational Affiliation
Gaziosmanpasa Taksim Research and Education Hospital, Otorhinolaryngology Deparment
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Mehmet E Dinc, MD
Organizational Affiliation
Gaziosmanpasa Taksim Research and Education Hospital, Otorhinolaryngology Deparment
Official's Role
Principal Investigator
Facility Information:
Facility Name
Gaziosmanpasa Taksim Research and Education Hospital, Department of Otorhinolaryngology
City
Istanbul
State/Province
Gaziosmanpasa
ZIP/Postal Code
00000
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Berke Ozucer, MD
Phone
90-530-963-5939
Email
berkeozucer@gmail.com
First Name & Middle Initial & Last Name & Degree
Emre M Dinc, MD
Phone
905065426492
Email
dremredinc@hotmail.com
12. IPD Sharing Statement
Citations:
PubMed Identifier
26616708
Citation
Fedok FG. Costal Cartilage Grafts in Rhinoplasty. Clin Plast Surg. 2016 Jan;43(1):201-12. doi: 10.1016/j.cps.2015.08.002. Epub 2015 Oct 24.
Results Reference
background
PubMed Identifier
26616707
Citation
Cochran CS. Harvesting Rib Cartilage in Primary and Secondary Rhinoplasty. Clin Plast Surg. 2016 Jan;43(1):195-200. doi: 10.1016/j.cps.2015.09.018. Epub 2015 Oct 23.
Results Reference
background
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Effect of Costal Harvesting Technique on Postoperative Donor-site Morbidity: Does Muscle Sparing Technique Cause Less Postoperative Pain ? A Clinical Trial
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