To evaluate the safety and effectiveness of the laparoscopic surgical system（Carina™ Surgical Platform, developed by Ronovo Surgical, Inc) for use in gastrectomy.
Source data verification: Cross-check between paper and electronic case report forms. Standard Operating Procedures: The investigator is responsible for patient recruitment, while a independent statistician handles data collection and management. When source data is modified, changes must be traceable in both the electronic system and paper documents. Statistical analysis plan: Categorical variables were analyzed using chi-square tests, while ordinal data were assessed using non-parametric tests. Continuous variables were analyzed using independent samples t-tests or non-parametric methods, as appropriate. Handling of Missing Data: Missing data will be handled according to the classification of each dataset. For the Full Analysis Set (FAS), missing values for primary efficacy and safety endpoints will be imputed using the Worst Observation Carry Forward (WOCF) method, and considered as treatment failure or the occurrence of serious complications. No imputation will be performed for missing values in other datasets or for other secondary/exploratory endpoints.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
20
A modular surgical robot that offers greater flexibility in the number of instrument arms and surgical layout options.
the Affiliated Hospital of QIngdao University
Qingdao, Shandong, China
Incidence of Serious Complications
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.
Time frame: From the beginning of surgery until hospital discharge, up to 16 weeks
Rate of No Surgical Conversion
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.
Time frame: From the start of surgery to the end of surgery, up to 5 hours
Instrument Defects
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.
Time frame: From the start of surgery to the end of surgery
Incidence of Device-Related Adverse Events and Serious Adverse Events
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.
Time frame: From the beginning of surgery until hospital discharge, up to 16 weeks
Postoperative Mortality Rate
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Postoperative death is defined as death resulting from causes directly related to the current surgical intervention.
Time frame: Perioperative
Incidence of Postoperative Complications
Any adverse event representing a deviation from the expected postoperative recovery was assessed and classified using the Clavien-Dindo complication grading system.
Time frame: From the beginning of surgery until hospital discharge, up to 16 weeks
Pain Score
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.
Time frame: Pain assessments were performed twice: once at 24 hours after surgery and once prior to hospital discharge.
Intraoperative Physiological Load Assessment of the Surgeon
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.
Time frame: An assessment was conducted immediately upon completion of the surgical procedure.
Incidence of System Repairable Failures
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.
Time frame: An assessment was conducted immediately upon completion of the surgical procedure.
Postoperative Length of Hospital Stay
Postoperative length of hospital stay was calculated as the number of days between the date of surgery and the date of discharge.
Time frame: Perioperative
Robot-Assisted Surgery Time
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.
Time frame: During surgery
Intraoperative Transfusion Rate
The proportion of participants who underwent blood transfusion during the surgical procedure.
Time frame: During surgery
Intraoperative Mental Workload Assessment of the Surgeon
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; "
Time frame: An assessment was conducted immediately upon completion of the surgical procedure.
Intraoperative Blood Loss
Blood loss was estimated using visual assessment, measurement via vacuum suction devices, or by weighing blood-soaked gauze.
Time frame: During surgery
System Setup Time
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.
Time frame: During surgery
Incidence of System Serious Failures
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.
Time frame: During surgery
Instrument Performance Evaluation
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.
Time frame: An assessment was conducted immediately upon completion of the surgical procedure.