First Appendectomy Using Revolve Surgical Robotic Arm

Overview

This study is testing a new surgical device called the Revolve Surgical System (RSS) during appendix removal surgery. The RSS is designed to help surgeons perform minimally invasive surgery with improved precision and stability while working at the patient's bedside, similar to standard laparoscopic surgery but with robotic assistance. This will be the first time the device is used in patients. It will be evaluated in three adults with uncomplicated appendicitis who are already scheduled to have an appendectomy. The purpose of the study is to assess whether the device can be used safely and effectively and to better understand how it performs during surgery.

This study is testing a new Canadian surgical device called the Revolve Surgical System (RSS) during minimally invasive appendix removal surgery (appendectomy). The RSS is a small robotic support arm that helps the surgeon hold and control the camera and surgical instruments more steadily. It is designed to reduce hand tremor, improve precision, and decrease the need for extra assistants, while allowing the surgeon to remain beside the patient rather than operating from a remote console. This will be the first time the RSS is used in human patients. Because of this, the main goal of the study is to make sure the device can be used safely and effectively during a routine operation. The study will include three adult patients with uncomplicated appendicitis who are already scheduled for a standard laparoscopic appendectomy. The study will be done in a gradual, step-by-step way. In the first patient, the RSS will only hold the camera. In the second, it will hold the camera and one instrument. In the third, it will hold the camera and two instruments. This careful approach allows the surgical team to evaluate safety before increasing how much the device is used. All other aspects of care will be the same as standard treatment. Patients will receive routine anesthesia, monitoring, and post-operative care. If the device does not function as expected at any time, it can be quickly removed, and the surgeon will immediately continue the operation using standard laparoscopic or open surgical techniques. Backup equipment will always be ready. Researchers will record information such as setup time, length of surgery, any need to switch back to standard methods, and whether any device issues occur. Usual recovery information and any complications will also be tracked. Surgeons and patients may be asked to complete short feedback questionnaires. There may be no direct benefit to participants, but the study could help improve future surgical care by making advanced minimally invasive technology more accessible and efficient. Findings from this pilot study will guide decisions about larger future studies.