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.
The study assessed the intraoperative adverse events (device-related and/or procedure-related), postoperative complications, perioperative recovery outcomes, surgical specimen quality, and pathological indices of Single-port robot-assisted radical gastrectomy for gastric cancer.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
20
Single-port Robotic Radical Gastrectomy for Gastric Cancer
Daping Hospital
Chongqing, Chongqing Municipality, China
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.
Time frame: Intraoperative and postoperative 30 days
Conversion rate
Conversion to open or laparotomy surgery due to intraoperative complications , technical difficulties, or inability to successfully complete predefined procedural steps .
Time frame: Intraoperative
Length of incision
The total length (in centimeters) of the surgical skin incision made during the procedure, measured immediately after wound closure.
Time frame: Intraoperative
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.
Time frame: Intraoperative
Operative Time
The duration (in minutes) from the initial skin incision to final wound closure, excluding anesthesia induction and emergence.
Time frame: Intraoperative
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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Time frame: 7 days after surgery
Number of Lymph Nodes Harvested
The total count of lymph nodes removed during the lymphadenectomy and confirmed by pathological examination.
Time frame: 7 days after surgery