This study is a single-center, phase 2a exploratory clinical study based on IDEAL framework. The intraoperative and postoperative complications were analyzed to evaluate the safety, feasibility and clinical efficacy of single-port robot-assisted gastric tumor resection.
(1) Age: 18-75 years; (2) Histologically confirmed gastric adenocarcinoma by endoscopic biopsy; (3) Preoperatively staged as either endoscopically unresectable T1, or cT2-4a with or without nodal involvement (N-/+), and no distant metastasis (M0), according to the 7th edition of the AJCC Cancer Staging Manual; (4) Eligible for potentially curative surgical resection; (5) Eastern Cooperative Oncology Group (ECOG) performance status score of 0-1; (6) American Society of Anesthesiologists (ASA) physical status classification of I-III; (7) Provision of written informed consent.
(1) Pregnant or lactating women; (2) Severe psychiatric disorder; (3) History of prior upper abdominal surgery; (4) Previous gastrectomy, endoscopic submucosal dissection (ESD), or endoscopic mucosal resection (EMR); (5) Preoperative imaging showing regional lymphadenopathy with lymph node(s) larger than 3 cm in diameter; (6) History of another primary malignancy within the past 5 years; (7) Prior neoadjuvant chemotherapy or radiotherapy; (8) History of cerebrovascular or cardiovascular event (e.g., stroke or myocardial infarction) within the past 6 months; (9) Systemic corticosteroid use for more than one month within the past month; (10) Requirement for concomitant surgery for other conditions; (11) Need for emergency surgery due to gastric cancer-related complications (e.g., bleeding, obstruction, or perforation); (12) Participation in another interventional clinical trial previously; (13) Active severe infectious disease; (14) Severe systemic disease.
Single group
Single-port Robotic Radical Gastrectomy for Gastric Cancer
Procedure/SurgerySingle-port Robotic Radical Gastrectomy for Gastric Cancer
Intraoperative adverse events and 30-day postoperative complications
Intraoperative adverse events (device and/or procedure-related). Events were recorded as Preferred Term and classified under System Organ Class as per MedDRA Common Terminology Criteria for Adverse Events (CTCAE) coding guidelines (https://evs.nci.nih.gov/ftp1/CTCAE/About.html). Postoperative complications will refer to any medical occurrence directly attributed to the surgical procedure within the first 30 days.
Conversion rate
Conversion to open or laparotomy surgery due to intraoperative complications , technical difficulties, or inability to successfully complete predefined procedural steps .
Length of incision
The total length (in centimeters) of the surgical skin incision made during the procedure, measured immediately after wound closure.
Intraoperative Blood Loss
The estimated volume of blood lost during surgery (in milliliters), calculated based on suction collection volume and the weight of used gauze sponges, using standard conversion methods.
Operative Time
The duration (in minutes) from the initial skin incision to final wound closure, excluding anesthesia induction and emergence.
Postoperative Length of Hospital Stay
The number of days between the day of surgery (postoperative day 0) and the day of hospital discharge, inclusive of the discharge day if applicable per institutional protocol.
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