This multicenter randomized non-inferiority trial evaluates single-port versus multi-port robotic-assisted radical distal gastrectomy in patients with gastric cancer. A prespecified prospective substudy will assess early postoperative pain, abdominal wall trauma, and early recovery between the two surgical approaches.
Age 18-85 years, irrespective of sex.
Histologically confirmed primary gastric adenocarcinoma based on endoscopic biopsy.
The primary tumor is located in the middle or distal third of the stomach, or at another site considered amenable to radical distal gastrectomy. Preoperative evaluation indicates that robot-assisted radical distal gastrectomy is technically feasible and that an R0 resection is anticipated. Patients who have received standard neoadjuvant therapy may also be eligible if reassessment confirms fulfillment of the above surgical criteria.
Clinical stage cT1-3N0-1M0 according to the 8th edition of the AJCC TNM staging system for gastric cancer, as assessed by gastroscopy and contrast-enhanced computed tomography of the chest, abdomen, and pelvis, with endoscopic ultrasonography, abdominal magnetic resonance imaging, or diagnostic laparoscopy performed when clinically indicated. Preoperative assessment should indicate that R0 resection can be achieved by distal gastrectomy, with no evidence of adjacent organ invasion or distant metastasis.
Body mass index (BMI) >35 kg/m².
Previous gastrectomy, or a history of major upper abdominal surgery considered likely to substantially compromise the feasibility or safety of robot-assisted distal gastrectomy, such as complex hepatobiliary-pancreatic surgery or surgery involving the esophagogastric junction. Previous uncomplicated laparoscopic cholecystectomy, appendectomy, or similar procedures are not, in principle, considered exclusionary.
Tumor-related acute obstruction, active major hemorrhage, or perforation requiring emergency surgery.
Preoperative confirmation of synchronous multiple gastric cancers or remnant gastric cancer, or the presence or history within the preceding 5 years of another active malignancy that may interfere with study treatment or assessment of study endpoints.
Parallel
Single-Port Robot-Assisted Radical Distal Gastrectomy
Procedure/SurgeryParticipants assigned to this intervention will undergo robot-assisted radical distal gastrectomy using a single-port surgical approach. The surgical procedure will be performed according to the predefined study protocol.
Multi-Port Robot-Assisted Radical Distal Gastrectomy
Procedure/SurgeryParticipants assigned to this intervention will undergo robot-assisted radical distal gastrectomy using a multi-port surgical approach. The surgical procedure will be performed according to the predefined study protocol.
Percentage of Participants With Technical Success of the Randomly Assigned Robotic Surgical Approach
Technical success is defined as completion of the protocol-specified gastrectomy, lymph node dissection, and gastrointestinal reconstruction using the robotic surgical approach assigned at randomization. In the single-port group, technical success requires completion using the single-port robotic system without conversion to multi-port robotic surgery, conventional laparoscopic surgery, or open surgery, and without any unplanned additional port beyond those permitted by the protocol. In the multi-port group, technical success requires completion using the multi-port robotic system without conversion to conventional laparoscopic surgery or open surgery. Failure to complete the assigned robotic procedure because of participant-related, operative, or device-related reasons will be classified as technical failure. The prespecified noninferiority margin is -10 percentage points.
Total Operative Time
Total duration of the surgical procedure, recorded in minutes according to the protocol-defined timing criteria.
Robotic Docking Time
Duration required for robotic docking, recorded in minutes according to the protocol-defined timing criteria.
Robotic Console Time
Duration of robotic console operation, recorded in minutes according to the protocol-defined timing criteria.
Intraoperative Blood Loss
Estimated volume of blood loss during surgery, recorded in milliliters.
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