NCT06155045

Brief 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. 1.Time taken to harvest the artery
  2. 2.Flow of blood between the two techniques

Trial Health

87
On Track

Trial Health Score

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

Enrollment
46

participants targeted

Target at below P25 for not_applicable coronary-artery-disease

Timeline
Completed

Started Jan 2021

Shorter than P25 for not_applicable coronary-artery-disease

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

January 1, 2021

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2021

Completed
1.9 years until next milestone

First Submitted

Initial submission to the registry

November 24, 2023

Completed
10 days until next milestone

First Posted

Study publicly available on registry

December 4, 2023

Completed
Last Updated

December 15, 2023

Status Verified

December 1, 2023

Enrollment Period

12 months

First QC Date

November 24, 2023

Last Update Submit

December 7, 2023

Conditions

Keywords

CABG, LIMA harvesting, CAD

Outcome Measures

Primary Outcomes (2)

  • Operative time

    Time taken to perform the harvesting of the LIMA

    10-20 min

  • Blood flow/min

    Post dividing of the LIMA: blood from the LIMA is measured for 1 min

    1 min

Study Arms (2)

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.

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.

Procedure: Conventional Arm

Interventions

This technique comes the C02 blower with electrocautery. Thereby, producing vasodilatation due to the gas and dissection aided by the electrocautery.

Modified Carbo-dissection technique

This technique uses only the electrocautery as conventional model

Conventional Arm

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Elective CABG
  • Hemodynamically stable CAD patients

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Government Medical College Kottayam

Kottayam, Kerala, 686008, India

Location

Related Publications (4)

  • 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.

    PMID: 29300076BACKGROUND
  • Ozkan 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.

    PMID: 15354091BACKGROUND
  • Lee 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.

  • Nair 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.

MeSH Terms

Conditions

Coronary Artery DiseaseCoronary Artery Disease, Autosomal Dominant, 1

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular Diseases

Study Officials

  • Dinesh Kumar Sathanantham, MBBS MS MCh

    Government Medical College Kottayam

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Model Details: The interventional group was compared with the conventional group in terms of two parameters : 1) operative time 2) blood flow/min
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Resident in Dept. of Cardiovascular and Thoracic Surgery

Study Record Dates

First Submitted

November 24, 2023

First Posted

December 4, 2023

Study Start

January 1, 2021

Primary Completion

December 31, 2021

Study Completion

December 31, 2021

Last Updated

December 15, 2023

Record last verified: 2023-12

Data Sharing

IPD Sharing
Will not share

The two parameters: Operative time and Blood flow/min between two techniques will be shared. Co-morbidities data will also be shared

Locations