Impact of Total Coronary Revascularization Via Left Anterior Thoracotomy (TCRAT) vs. Robotic-Assisted Harvesting of LIMA (ITcrats)

NCT06988735 | Not Yet Recruiting DMC

• 1 other identifier: IABF-16-05-25
• Study Type: interventional
• Target: 182
• Locations: 1 country
• Sites: 1

Brief Summary

The two types of total coronary revascularization via left anterior thoracotomy (TCRAT) might have their potential benefits and disadvantages. The proposed randomized clinical trial here will compare 'RA-TCRAT' with 'Nonrobotic TCRAT' procedures concerning effects on hospital stays, overall healthcare costs, safety, and feasibility. If the two TCRAT procedures are comparably effective and safe, the 'Nonrobotic TCRAT' procedure is probably preferred as it seems easier to use. However, if the 'Nonrobotic TCRAT' procedure is less effective and less safe than the "robotic TCRAT,' that procedure should be preferred.

Conditions

Minimally Invasive Coronary Revascularization Surgery; Elective Surgery

Keywords

minimally invasive coronary revascularization surgery; robotic-assisted coronary artery bypass graft (RA-CABG); major adverse cardiovascular events (MACCE); major adverse cerebrovascular events; cardiopulmonary bypass (CPB); hospital stays; costs and charges

Outcome Measures

Primary Outcomes (1)

• The length of hospital stay

  The primary outcome is the length of hospital stay, defined as the time from surgery until discharge or in-hospital death.

  For 120 days from surgery

Secondary Outcomes (22)

• Overall costs and charges

  For 120 days from surgery until hospital discharge or death

• The operating room stay

  For 12 hours from entrance to the operating rooms

• The postoperative ICU stay

  For 120 days from surgery

• The need for re-explorative surgery during the same admission.

  For 120 days from surgery

• Perioperative need for packed red blood cells (PRBCs) transfusion

  For 72 hours from surgery

Study Arms (2)

Nonrobotic TCRAT

PLACEBO COMPARATOR

Nonrobotic TCRAT for CABG

Procedure: Nonrobotic TCRAT

Robotic TCRAT

ACTIVE COMPARATOR

Robotic TCRAT for CABG

Procedure: Robotic TCRAT

Interventions

Nonrobotic TCRAT PROCEDURE

Nonrobotic TCRAT for CABG

Nonrobotic TCRAT

Robotic TCRAT PROCEDURE

Robotic TCRAT for CABG

Robotic TCRAT

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Scheduled for any type of elective minimally invasive coronary revascularization surgery.
• Using CPB.
• General anesthesia is provided in an endotracheally intubated patient

You may not qualify if:

• Planned for coronary revascularization surgery without CPB;
• Planned for a combined coronary revascularization surgery and a valve or intra-cardiac surgery;
• LVEF less than 35%;
• Preoperative cardiogenic shock;
• Pregnancy;
• Scheduled for re-do or emergency surgery;
• Consent for another interventional study during anesthesia;
• No written informed consent;
• Preoperative need for mechanical circulatory support;
• Preoperative need for invasive ventilatory support;

Sponsors & Collaborators

• Mohamed R El Tahan: lead

Study Sites (1)

Imam Abdulrahamn Bin Faisal University (Former, Dammam University)

Dammam, Eastern, Saudi Arabia,, 31952, Saudi Arabia

Location

Related Publications (12)

• Gong W, Cai J, Wang Z, Chen A, Ye X, Li H, Zhao Q. Robot-assisted coronary artery bypass grafting improves short-term outcomes compared with minimally invasive direct coronary artery bypass grafting. J Thorac Dis. 2016 Mar;8(3):459-68. doi: 10.21037/jtd.2016.02.67.

  PMID: 27076941 BACKGROUND

• Lin TH, Wang CW, Shen CH, Chang KH, Lai CH, Liu TJ, Chen KJ, Chen YW, Lee WL, Su CS. Clinical outcomes of multivessel coronary artery disease patients revascularized by robot-assisted vs conventional standard coronary artery bypass graft surgeries in real-world practice. Medicine (Baltimore). 2021 Jan 22;100(3):e23830. doi: 10.1097/MD.0000000000023830.

  PMID: 33545949 BACKGROUND

• Giambruno V, Chu MW, Fox S, Swinamer SA, Rayman R, Markova Z, Barnfield R, Cooper M, Boyd DW, Menkis A, Kiaii B. Robotic-assisted coronary artery bypass surgery: an 18-year single-centre experience. Int J Med Robot. 2018 Jun;14(3):e1891. doi: 10.1002/rcs.1891. Epub 2018 Jan 19.

  PMID: 29349908 BACKGROUND

• Marin-Cuartas M, Sa MP, Torregrossa G, Davierwala PM. Minimally invasive coronary artery surgery: Robotic and nonrobotic minimally invasive direct coronary artery bypass techniques. JTCVS Tech. 2021 Oct 13;10:170-177. doi: 10.1016/j.xjtc.2021.10.008. eCollection 2021 Dec. No abstract available.

  PMID: 34984377 BACKGROUND

• Kofler M, Stastny L, Reinstadler SJ, Dumfarth J, Kilo J, Friedrich G, Schachner T, Grimm M, Bonatti J, Bonaros N. Robotic Versus Conventional Coronary Artery Bypass Grafting: Direct Comparison of Long-Term Clinical Outcome. Innovations (Phila). 2017 Jul/Aug;12(4):239-246. doi: 10.1097/IMI.0000000000000393.

  PMID: 28777131 BACKGROUND

• Babliak O, Demianenko V, Melnyk Y, Revenko K, Babliak D, Stohov O, Pidgayna L. Multivessel Arterial Revascularization via Left Anterior Thoracotomy. Semin Thorac Cardiovasc Surg. 2020 Winter;32(4):655-662. doi: 10.1053/j.semtcvs.2020.02.032. Epub 2020 Feb 28.

  PMID: 32114114 BACKGROUND

• Sellin C, Asch S, Belmenai A, Mourad F, Voss M, Dorge H. Early Results of Total Coronary Revascularization via Left Anterior Thoracotomy. Thorac Cardiovasc Surg. 2023 Sep;71(6):448-454. doi: 10.1055/s-0042-1758149. Epub 2022 Nov 11.

  PMID: 36368676 BACKGROUND

• Babliak O, Demianenko V, Melnyk Y, Revenko K, Pidgayna L, Stohov O. Complete Coronary Revascularization via Left Anterior Thoracotomy. Innovations (Phila). 2019 Aug;14(4):330-341. doi: 10.1177/1556984519849126. Epub 2019 May 20.

  PMID: 31106625 BACKGROUND

• Caynak B, Sicim H. Routine minimally invasive approach via left anterior mini-thoracotomy in multivessel coronary revascularization. J Card Surg. 2022 Apr;37(4):769-776. doi: 10.1111/jocs.16259. Epub 2022 Jan 20.

  PMID: 35060197 BACKGROUND

• Marin Cuartas M, Javadikasgari H, Pfannmueller B, Seeburger J, Gillinov AM, Suri RM, Borger MA. Mitral valve repair: Robotic and other minimally invasive approaches. Prog Cardiovasc Dis. 2017 Nov-Dec;60(3):394-404. doi: 10.1016/j.pcad.2017.11.002. Epub 2017 Nov 9.

  PMID: 29128572 BACKGROUND

• Smilowitz NR, Gupta N, Ramakrishna H, Guo Y, Berger JS, Bangalore S. Perioperative Major Adverse Cardiovascular and Cerebrovascular Events Associated With Noncardiac Surgery. JAMA Cardiol. 2017 Feb 1;2(2):181-187. doi: 10.1001/jamacardio.2016.4792.

  PMID: 28030663 BACKGROUND

• Patrick WL, Iyengar A, Han JJ, Mays JC, Helmers M, Kelly JJ, Wang X, Ghoreishi M, Taylor BS, Atluri P, Desai ND, Williams ML. The learning curve of robotic coronary arterial bypass surgery: A report from the STS database. J Card Surg. 2021 Nov;36(11):4178-4186. doi: 10.1111/jocs.15945. Epub 2021 Aug 29.

  PMID: 34459029 BACKGROUND

Study Officials

• Mohamed R El Tahan, MD

  Consultant in Cardiac Anesthesia

  STUDY CHAIR

• Fahad Makhdoum, MD

  Assistant Professor, Cardiac Surgery

  PRINCIPAL INVESTIGATOR

• Yasser F ElGhoneimy, MD

  Professor, Cardiac Surgery

  STUDY DIRECTOR

Central Study Contacts

Moahmed R El Tahan, MD

CONTACT

0096569371849; mohamedrefaateltahan@yahoo.com

Yasser f ElGhoneimy, MD

CONTACT

+966 59 777 7012; yfarag@iau.edu.sa

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Further minimization of bias will be achieved by involving two independent investigators. The researcher responsible for performing the surgery will perform the Randomization directly before the start of anesthesia. A second investigator, who will not be blinded for the randomization arm, will score the primary and secondary postoperative outcome measures.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Consultant in Cardiac Anesthesia

Model Details: A single-center prospective randomized controlled clinical trial- and patient-blinded comparative trial in patients scheduled for surgical coronary revascularization. The RCT will be conducted according to Good Clinical Practice (GCP) Guidelines and comply with the principles of the Declaration of Helsinki. The RCT will be registered in a public registry, and the study protocol with its statistical analysis plan will be published before the enrollment of the first patient.

Study Record Dates

• First Submitted: May 16, 2025
• First Posted: May 25, 2025
• Study Start: July 1, 2025
• Primary Completion (Estimated): July 1, 2027
• Study Completion (Estimated): August 1, 2027
• Last Updated: June 4, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR, ANALYTIC CODE
• Time Frame: Beginning six months after publication and for a period of five years.
• Access Criteria: Data access will be granted following review and approval of a research proposal and the signing of a data access agreement. Requests should be directed to the corresponding author.

Locations

SA (1)