Carina™ Surgical Platform for Minimal Radical Gastrectomy

Any deviation from the expected postoperative recovery was considered an adverse event and was classified according to the Clavien-Dindo complication grading system. Only complications of grade III or above were included in the analysis.

No intraoperative conversion occurred from the robotic laparoscopic endoscopic surgical system-assisted procedure to another surgical instrument control system, conventional laparoscopy, or open surgery. The laparoscopic endoscopic surgical system is a medical device intended to assist the surgeon in accomplishing predefined surgical tasks. Completion of the remaining surgical procedures via laparoscopy or open surgery after the intended tasks have been performed using the system is not regarded as a conversion.

Refers to unreasonable risks to human health or life posed by the surgical instruments used with the laparoscopic endoscopic surgical system during the clinical trial, under conditions of intended use. Such risks may arise from labeling errors, quality defects, malfunctions, or other device-related issues.

Any deviation from the expected postoperative recovery caused by surgical instruments was considered an adverse event and was classified according to the Clavien-Dindo complication grading system. Only complications of grade III or above were included in the analysis.

Postoperative death is defined as death resulting from causes directly related to the current surgical intervention.

Any adverse event representing a deviation from the expected postoperative recovery was assessed and classified using the Clavien-Dindo complication grading system.

Pain was assessed using the revised Wong-Baker FACES Pain Rating Scale, with scores ranging from 0 (no pain) to 10 (worst possible pain), indicating increasing severity.

Regional assessments were performed, covering the following areas: four fingers (excluding the thumb) of both hands, bilateral thumbs, bilateral dorsum of hands, wrists, forearms, upper arms, as well as the neck and back. Each region was scored on a scale from 0 to 10, with 0 indicating no discomfort and 10 indicating extreme discomfort in that specific area. Refer to: Lukasz F, Christopher S, Adrian Z, et al. Robot-assisted single-site compared with laparoscopic single-incision cholecystectomy for benign gallbladder disease: protocol for a randomized controlled trial[J]. BMC Surg. 2017 Feb 9;17(1):13.

A System Repairable Failures is defined as a malfunction occurring during robot-assisted surgery that can be resolved within a short period (within 1 hour) without causing significant disruption to the surgical workflow or alteration of the surgical procedure.

Postoperative length of hospital stay was calculated as the number of days between the date of surgery and the date of discharge.

Robot-assisted operative time was defined as the duration from the moment the surgeon initiated control of the surgical instruments to the moment the first robotic arm of the laparoscopic endoscopic surgical system was disengaged from the trocar and instrument control was concluded.

The proportion of participants who underwent blood transfusion during the surgical procedure.

According to "Subjective Mental Effort Questionnaire". Refer to "van der Schatte Olivier RH, Van't Hullenaar CD, Ruurda JP, Broeders IA. Ergonomics, user comfort, and performance in standard and robot-assisted laparoscopic surgery. Surg Endosc. 2009;23(6):1365-1371. doi: 10.1007/s00464-008-0184-6." 0 is "no effort at all" and 150 is "exceptional amount of effort; "

Blood loss was estimated using visual assessment, measurement via vacuum suction devices, or by weighing blood-soaked gauze.

System preparation time was defined as the interval between the moment the first robotic arm of the laparoscopic endoscopic surgical system was docked to the trocar and the moment the surgeon gained control of the instruments to initiate the procedure.

System preparation time was defined as the interval between the moment the first robotic arm of the laparoscopic endoscopic surgical system was docked to the trocar and the moment the surgeon gained control of the instruments to initiate the procedure.

System preparation time was defined as the interval between the moment the first robotic arm of the laparoscopic endoscopic surgical system was docked to the trocar and the moment the surgeon gained control of the instruments to initiate the procedure.

A serious system failure is defined as a malfunction occurring during robot-assisted surgery that either cannot be resolved within a short period (within 1 hour), or has a substantial impact on the surgical procedure or intraoperative workflow.

The laparoscopic camera system and intraoperative surgical instruments-including the ultrasonic scalpel, electrosurgical scissors, needle holder, and grasping forceps-were evaluated on a four-grade scale: excellent, good, fair, and poor. Evaluation parameters included clarity of the surgical field, 3D visual fatigue, instrument stability, response latency, and operational flexibility.