Coronary Artery DiseaseCABGNCT06155045
Comparing a New Technique of Combining Carbon-dioxide With Electrocautery With Usual Technique of Stand-alone Electrocautery for Taking Down Left Internal Mammary Artery for Coronary Artery Bypass(CABG)
A study testing Modified Carbo-dissection Technique and Conventional Arm in people with Coronary Artery Disease and Coronary Artery Disease With Myocardial Infarction, run by Government Medical College Kottayam at 1 site in India.
Trial summary
The goal of this study is to compare the efficacy of a new harvesting technique for an arterial conduit(LIMA - Left Internal Mammary artery) in patients undergoing Coronary artery bypass grafting. The researcher will compare the 1. Time taken to harvest the artery 2. Flow of blood between the two techniques Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Coronary Artery Disease, Coronary Artery Disease With Myocardial Infarction
- What is being tested?
- Modified Carbo-dissection Technique and Conventional Arm
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 1 siteIndia
- Study dates
- 1 Jan 2021to 31 Dec 2021
- 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Elective CABG
- Hemodynamically stable CAD patients
Who cannot join
- Re-operation, previous sternotomy (where LIMA is already dissected)
- concomitant valve operation, ventricular aneurysm resection
- other additional major cardiac procedures
- Patients with chronic obstructive pulmonary disease
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Comparative Study Between Conventional & Modified Carbo-dissection Techniques for LIMA Harvesting in CABG Patients
The goal of this study is to compare the efficacy of a new harvesting technique for an arterial conduit(LIMA - Left Internal Mammary artery) in patients undergoing Coronary artery bypass grafting. The researcher will compare the
- Time taken to harvest the artery
- Flow of blood between the two techniques
Read the detailed description
Following consultation to our department, after a detailed history and clinical examination,patients with CAD, being planned for CABG, will be subjected to a detailed pre-op Echocardiogram and coronary angiogram. After necessary pre-op assessment, patient will be taken up for the surgery. Invasive monitoring will be done.
Following dissection of LIMA by the above mentioned technique, flow of blood from the harvested LIMA, for one whole minute is noted. The operative time required for the dissection of LIMA will be noted and entered.
The data between the two techniques will be compared statistically.
- Being tested
- Modified Carbo-dissection Technique, Conventional Arm
- Keywords
- CABG, LIMA harvesting, CAD
- Medical subject headings
- Coronary Artery Disease, Coronary Artery Disease, Autosomal Dominant, 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Modified Carbo-dissection TechniqueProcedure or surgery
This technique comes the C02 blower with electrocautery. Thereby, producing vasodilatation due to the gas and dissection aided by the electrocautery.
Conventional ArmProcedure or surgery
This technique uses only the electrocautery as conventional model
| Study group | Role | What they receive |
|---|---|---|
| Modified Carbo-dissection technique | Experimental | The carbo-dissection technique is performed using an improvised instrument that combines an electrocautery pencil (ValleylabTM Force FX electrocautery Pencil, Covidien, USA) with a CO2 mister blower (PerfX® Heart Lung pack Blower/Mister Kit, B L Lifesciences, Noida, India) and the instruments are fixed together using silk ties.The electrocautery is used in the coagulation mode at a setting of 10 to 15. The C02 flow is set at 2 to 3 litres/minute. Saline flow is adjusted to a level that does not hinder the effective coagulation but still prevents drying and desiccation of the tissues. Following the dissection of LIMA by the techniques mentioned above, blood flow from the harvested LIMA for one whole minute was noted(1 min post division of LIMA). The operative time required for LIMA dissection was also noted and entered. Patient's s demographic data were also collected and entered. Receives: Procedure: Modified Carbo-dissection Technique |
| Conventional Arm | Active comparator | The conventional technique is performed using an electrocautery pencil (ValleylabTM Force FX electrocautery Pencil, Covidien, USA). The electrocautery is used in the coagulation mode at a setting of 10 to 15. Following the dissection of LIMA, blood flow from the harvested LIMA for one whole minute was noted(1 min post division of LIMA). The operative time required for LIMA dissection was also noted and entered. Patient's s demographic data were also collected and entered. Receives: Procedure: Conventional Arm |
What is being measured
The primary outcome is the main question the study is designed to answer.
Operative time
Time taken to perform the harvesting of the LIMA
Measured: 10-20 min
Blood flow/min
Post dividing of the LIMA: blood from the LIMA is measured for 1 min
Measured: 1 min
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2023
- Study start1 Jan 2021
- Primary completion31 Dec 2021
- Study completion31 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Coronary Artery DiseaseStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The interventional group was compared with the conventional group in terms of two parameters : 1) operative time 2) blood flow/min
- Masking
- None (open label)
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- Government Medical College Kottayam
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dinesh Kumar Sathanantham, Government Medical College Kottayam
- Investigators
- Dinesh Kumar Sathanantham, MBBS MS MCh, Principal investigator, Government Medical College Kottayam
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06155045
- Sponsor's protocol ID
- 95/2020
- Acronym
- CABG
- Status last verified
- Dec 2023
- First submitted
- 24 Nov 2023
- Last updated
- 15 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The two parameters: Operative time and Blood flow/min between two techniques will be shared. Co-morbidities data will also be shared
Publications
Gilbert S, Singh D, Sivakumar MK. Modified carbodissection: A new technique for harvesting the internal mammary artery. Multimed Man Cardiothorac Surg. 2017 Oct 29;2017. doi: 10.1510/mmcts.2017.018.
PubMed 29300076Ozkan M, Koramaz I, Ulus AT, Tavil Y, Filizlioglu H, Baykan EC, Eryilmaz S, Inan B, Katircioglu SF, Ozyurda U. Effect of carbon dioxide insufflation on free internal thoracic artery flows: is it a vasodilator? J Thorac Cardiovasc Surg. 2004 Sep;128(3):354-6. doi: 10.1016/j.jtcvs.2003.11.006.
PubMed 15354091Lee ME. Carbodissection of the internal thoracic artery pedicle. Ann Thorac Surg. 1988 Oct;46(4):470-1. doi: 10.1016/s0003-4975(10)64671-1.
PubMed 3140750Nair JTK, Sathanantham DK, Thomas JK. Comparison of conventional and modified carbo-dissection techniques for LIMA harvesting in CABG. Indian J Thorac Cardiovasc Surg. 2025 Feb;41(2):162-166. doi: 10.1007/s12055-024-01780-z. Epub 2024 Jul 15.
PubMed 39822879
Study at a glance
From the registry record, last updated by the sponsor on 15 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparative Study Between Conventional & Modified Carbo-dissection Techniques for LIMA Harvesting in CABG Patients
- ClinicalTrials.gov ID
- NCT06155045
- Acronym / sponsor ID
- CABG / 95/2020
- Keywords
- CABG, LIMA harvesting, CAD
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- Government Medical College KottayamUniversity, hospital or other
- Study start
- 1 Jan 2021 (actual)
- Primary completion
- 31 Dec 2021 (actual)
- Study completion
- 31 Dec 2021 (actual)
- First posted
- 4 Dec 2023 (actual)
- 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 goal of this study is to compare the efficacy of a new harvesting technique for an arterial conduit(LIMA - Left Internal Mammary artery) in patients undergoing Coronary artery bypass grafting. The researcher will compare the
- Time taken to harvest the artery
- Flow of blood between the two techniques
Detailed description
Following consultation to our department, after a detailed history and clinical examination,patients with CAD, being planned for CABG, will be subjected to a detailed pre-op Echocardiogram and coronary angiogram. After necessary pre-op assessment, patient will be taken up for the surgery. Invasive monitoring will be done.
Following dissection of LIMA by the above mentioned technique, flow of blood from the harvested LIMA, for one whole minute is noted. The operative time required for the dissection of LIMA will be noted and entered.
The data between the two techniques will be compared statistically.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The interventional group was compared with the conventional group in terms of two parameters : 1) operative time 2) blood flow/min
| Arm | Type | Receives |
|---|---|---|
| Modified Carbo-dissection technique | Experimental | Procedure: Modified Carbo-dissection TechniqueThe carbo-dissection technique is performed using an improvised instrument that combines an electrocautery pencil (ValleylabTM Force FX electrocautery Pencil, Covidien, USA) with a CO2 mister blower (PerfX® Heart Lung pack Blower/Mister Kit, B L Lifesciences, Noida, India) and the instruments are fixed together using silk ties.The electrocautery is used in the coagulation mode at a setting of 10 to 15. The C02 flow is set at 2 to 3 litres/minute. Saline flow is adjusted to a level that does not hinder the effective coagulation but still prevents drying and desiccation of the tissues. Following the dissection of LIMA by the techniques mentioned above, blood flow from the harvested LIMA for one whole minute was noted(1 min post division of LIMA). The operative time required for LIMA dissection was also noted and entered. Patient's s demographic data were also collected and entered. |
| Conventional Arm | Active comparator | Procedure: Conventional ArmThe conventional technique is performed using an electrocautery pencil (ValleylabTM Force FX electrocautery Pencil, Covidien, USA). The electrocautery is used in the coagulation mode at a setting of 10 to 15. Following the dissection of LIMA, blood flow from the harvested LIMA for one whole minute was noted(1 min post division of LIMA). The operative time required for LIMA dissection was also noted and entered. Patient's s demographic data were also collected and entered. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Elective CABG
- Hemodynamically stable CAD patients
Key exclusion criteria (4 listed)
- Re-operation, previous sternotomy (where LIMA is already dissected)
- concomitant valve operation, ventricular aneurysm resection
- other additional major cardiac procedures
- Patients with chronic obstructive pulmonary disease
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 |
|---|---|---|
| Modified Carbo-dissection TechniqueThis technique comes the C02 blower with electrocautery. Thereby, producing vasodilatation due to the gas and dissection aided by the electrocautery. | Procedure or surgery | Modified Carbo-dissection technique |
| Conventional ArmThis technique uses only the electrocautery as conventional model | Procedure or surgery | Conventional Arm |
Primary outcome
Operative time
Time frame: 10-20 min
Time taken to perform the harvesting of the LIMA
Blood flow/min
Time frame: 1 min
Post dividing of the LIMA: blood from the LIMA is measured for 1 min
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Dec 2023.
- Background: PubMed 29300076Gilbert S, Singh D, Sivakumar MK. Modified carbodissection: A new technique for harvesting the internal mammary artery. Multimed Man Cardiothorac Surg. 2017 Oct 29;2017. doi: 10.1510/mmcts.2017.018.
- Background: PubMed 15354091Ozkan M, Koramaz I, Ulus AT, Tavil Y, Filizlioglu H, Baykan EC, Eryilmaz S, Inan B, Katircioglu SF, Ozyurda U. Effect of carbon dioxide insufflation on free internal thoracic artery flows: is it a vasodilator? J Thorac Cardiovasc Surg. 2004 Sep;128(3):354-6. doi: 10.1016/j.jtcvs.2003.11.006.
- Results publication: PubMed 3140750Lee ME. Carbodissection of the internal thoracic artery pedicle. Ann Thorac Surg. 1988 Oct;46(4):470-1. doi: 10.1016/s0003-4975(10)64671-1.
- Derived from this study: PubMed 39822879Nair JTK, Sathanantham DK, Thomas JK. Comparison of conventional and modified carbo-dissection techniques for LIMA harvesting in CABG. Indian J Thorac Cardiovasc Surg. 2025 Feb;41(2):162-166. doi: 10.1007/s12055-024-01780-z. Epub 2024 Jul 15.
- Individual participant dataSharing planned: No. The two parameters: Operative time and Blood flow/min between two techniques will be shared. Co-morbidities data will also be shared
Related trials for Coronary Artery Disease
Not yet recruiting
Effect of Stress Ball Use During Femoral Arterial Sheath Removal After Coronary Angiography
Femoral Arterial Sheath Removal, Stress Ball
Active, not recruiting
Shockwave™ vs Surgical Endarterectomy for Calcified Severe Common Femoral Artery Stenosis: Comparison of Efficacy, Safety and Long-Term Outcomes
Common Femoral Artery Stenosis, Calcification; Heart
Not yet recruitingPhase 4
Roxadustat and Myocardial Injury After Off-Pump Coronary Artery Bypass Surgery
Coronary Artery Disease, Coronary Artery Bypass Grafting
RecruitingObservational study
Preoperative Gastric Ultrasound and Left Ventricular Function in Coronary Artery Bypass Surgery
Coronary Artery Disease, Left Ventricular Systolic Dysfunction
Active, not recruiting
The OCTOBER Trial - European Trial on Optical Coherence Tomography Optimized Bifurcation Event Reduction (OCTOBER)
Ischaemic Heart Disease, Ischemic Heart Disease
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.
Dinesh Kumar Sathanantham, MBBS MS MCh principal investigator
Government Medical College Kottayam
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Modified Carbo-dissection Technique and Conventional Arm in people with Coronary Artery Disease and Coronary Artery Disease With Myocardial Infarction, run by Government Medical College Kottayam at 1 site in India.
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 4 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: finished, as of the sponsor's last update on 15 Dec 2023. 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 India. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Operative time (time frame: 10-20 min). The study lists 2 primary outcomes in all. 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 NCT06155045, which also lists 4 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 15 Dec 2023.