To evaluate the safety and efficacy of SP1000 and conventional laparoscopy in radical gastrectomy for proximal gastric cancer.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
90
An 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.
Standard 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.
The First Affiliated Hospital of Wenzhou Medical University
Wenzhou, Zhejiang, China
RECRUITINGIncidence 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.
Time frame: Within 30 days postoperatively.
Estimated Blood Loss
The amount of blood lost during the surgical procedure, measured in milliliters (mL).
Time frame: During the surgical procedure (Day 0).
Time to First Flatus
The time from the end of surgery until the participant's first passage of flatus, measured in days.
Time frame: Up to 30 days postoperatively.
Total Operation Time
The duration from the initial skin incision to the completion of skin closure, measured in minutes.
Time frame: During the surgical procedure (Day 0).
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.
Time frame: During the surgical procedure (Day 0).
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