About this trial
To evaluate the safety and efficacy of SP1000 and conventional laparoscopy in radical gastrectomy for proximal gastric cancer.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age between 18 and 75 years inclusive.
Disqualifiers
Clinical stage T4 or presence of distant metastasis.
Trial design
Parallel
Treatments tested in this trial
Single-Port Robotic Surgical System
DeviceAn investigational robotic-assisted surgical platform designed for single-port access. In this study, the system is utilized to perform radical proximal gastrectomy. The core surgical procedures are conducted through a centralized access point to assess the intraoperative safety and short-term clinical outcomes of this robotic-assisted approach.
Traditional Laparoscopic Surgery
Procedure/SurgeryStandard multi-port laparoscopic radical proximal gastrectomy performed as a clinical control. This procedure follows conventional laparoscopic techniques involving multiple abdominal incisions for the placement of surgical instruments and camera to treat proximal gastric cancer.
Treatment groups
Trial outcomes
Primary outcomes
Incidence of Total Postoperative Complications (Clavien-Dindo Grade ≥ II)
The proportion of participants experiencing at least one postoperative complication graded II or higher according to the Clavien-Dindo Classification. This includes surgery-related, systemic, and anesthesia-related complications. If a patient experiences multiple complications, only the most severe grade will be used for statistical analysis.
Secondary outcomes
Estimated Blood Loss
The amount of blood lost during the surgical procedure, measured in milliliters (mL).
Time to First Flatus
The time from the end of surgery until the participant's first passage of flatus, measured in days.
Total Operation Time
The duration from the initial skin incision to the completion of skin closure, measured in minutes.
Conversion Rate
The proportion of participants in the Single-Port group who require conversion to traditional multi-port laparoscopy or open surgery due to technical or safety factors.
Sponsors and contacts
Click on the lead sponsor to view all of their trials.