Nasal DeformityCOSTANCT02818634
Effect of Costal Harvesting Technique on Postoperative Donor-site Morbidity: Does Muscle Sparing Technique Cause Less Postoperative Pain ? A Clinical Trial
A study testing Harvesting rib cartilage in people with Nasal Deformity and Revision Rhinoplasty, run by Gaziosmanpasa Research and Education Hospital at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 17 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Nasal Deformity, Revision Rhinoplasty, Autogenous Rib Graft
- What is being tested?
- Harvesting rib cartilage
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Feb 2016to Aug 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 17 to 65 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Revision rhinoplasty
- when costal cartilage is harvested full-thickness
Who cannot join
- Fibromyalgia
- No consent
- When patient does not comply with follow-up
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Gaziosmanpasa Taksim Research and Education Hospital, Department of Otorhinolaryngology
Istanbul, Gaziosmanpasa, 00000
Berke Ozucer, MD, 90-530-963-5939, berkeozucer@gmail.com
Emre M Dinc, MD, 905065426492, dremredinc@hotmail.com
About this study
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
Read the 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.
- Being tested
- Harvesting rib cartilage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Harvesting rib cartilageProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Muscle-sparing | Active comparator | 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. Receives: Procedure: Harvesting rib cartilage |
| Muscle-cutting | Active comparator | 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). Receives: Procedure: Harvesting rib cartilage |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Postoperative Pain
Postoperative pain and its change from baseline to 45th postoperative day will be evaluated with Visual Analogue Scale
Measured: Postoperative first 45 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jun 2016 (estimated)
- Study startFeb 2016
- Primary completionJul 2016 (estimated)
- Study completionAug 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Nasal DeformityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Gaziosmanpasa Research and Education Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Berke Ozucer, Gaziosmanpasa Research and Education Hospital
- Investigators
- Berke Ozucer, MD, Study director, Gaziosmanpasa Taksim Research and Education Hospital, Otorhinolaryngology DeparmentMehmet E Dinc, MD, Principal investigator, Gaziosmanpasa Taksim Research and Education Hospital, Otorhinolaryngology Deparment
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02818634
- Sponsor's protocol ID
- COSTA
- Acronym
- COSTA
- Status last verified
- Jun 2016
- First submitted
- 17 Jun 2016
- Last updated
- 30 Jun 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 26616708Cochran 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.
PubMed 26616707
Study at a glance
From the registry record, last updated by the sponsor on 30 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Costal Harvesting Technique on Postoperative Donor-site Morbidity: Does Muscle Sparing Technique Cause Less Postoperative Pain ? A Clinical Trial
- ClinicalTrials.gov ID
- NCT02818634
- Acronym / sponsor ID
- COSTA / COSTA
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Gaziosmanpasa Research and Education HospitalOther government
- Study start
- Feb 2016
- Primary completion
- Jul 2016 (estimated)
- Study completion
- Aug 2016 (estimated)
- First posted
- 30 Jun 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Muscle-sparing | Active comparator | Procedure: Harvesting rib cartilageFollowing 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. |
| Muscle-cutting | Active comparator | Procedure: Harvesting rib cartilageFollowing 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). |
Who may qualify
- Ages
- 17 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Revision rhinoplasty
- when costal cartilage is harvested full-thickness
Key exclusion criteria (3 listed)
- Fibromyalgia
- No consent
- When patient does not comply with follow-up
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Harvesting rib cartilage | Procedure or surgery | Muscle-cutting, Muscle-sparing |
Primary outcome
Change in Postoperative Pain
Time frame: Postoperative first 45 days
Postoperative pain and its change from baseline to 45th postoperative day will be evaluated with Visual Analogue Scale
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jun 2016.
- Background: PubMed 26616708Fedok 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.
- Background: PubMed 26616707Cochran 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Berke Ozucer, MD study director
Gaziosmanpasa Taksim Research and Education Hospital, Otorhinolaryngology Deparment
Mehmet E Dinc, MD principal investigator
Gaziosmanpasa Taksim Research and Education Hospital, Otorhinolaryngology Deparment
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Harvesting rib cartilage in people with Nasal Deformity and Revision Rhinoplasty, run by Gaziosmanpasa Research and Education Hospital at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 30 Jun 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Berke Ozucer, MD (905309635939, berkeozucer@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Postoperative Pain (time frame: Postoperative first 45 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02818634, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jun 2016.