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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorMohamed R El Tahan

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Scheduled for any type of elective minimally invasive coronary revascularization surgery.

Using CPB.

General anesthesia is provided in an endotracheally intubated patient

Disqualifiers

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;

Trial design

Design model

Parallel

Treatments tested in this trial

  • Nonrobotic TCRAT

    Procedure/Surgery

    Nonrobotic TCRAT for CABG

  • Robotic TCRAT

    Procedure/Surgery

    Robotic TCRAT for CABG

Treatment groups

182 Participants
are divided into 2 treatment groups
Group A: Nonrobotic TCRATPlacebo comparator 1 intervention
Group B: Robotic TCRATActive comparator 1 intervention

Trial outcomes

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.

Time frame
For 120 days from surgery

Secondary outcomes

1

Overall costs and charges

The overall healthcare costs and healthcare charges

Time frame
For 120 days from surgery until hospital discharge or death
2

The operating room stay

The operating room stays from entrance to transferring the patient to the ICU.

Time frame
For 12 hours from entrance to the operating rooms
3

The postoperative ICU stay

The postoperative ICU stay from surgery date and time.

Time frame
For 120 days from surgery
4

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

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

Time frame
For 120 days from surgery

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Mohamed R El Tahan

Lead sponsor

Imam Abdulrahman Bin Faisal University

Sponsor institution

This trial is not recruiting at the moment. You can still explore other options: