Daping Hospital
Chongqing, Chongqing Municipality, 400042, China
NCT Number: NCT07237126
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.
Trial opening soon.
Get Notified18 year–75 year
All sexes
Interventional
Not applicable
Chongqing, Chongqing Municipality, 400042, China
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Single-port Robotic Radical Gastrectomy for Gastric Cancer
Time frame: Intraoperative and postoperative 30 days
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
Conversion to open or laparotomy surgery due to intraoperative complications , technical difficulties, or inability to successfully complete predefined procedural steps .
Time frame: Intraoperative
The total length (in centimeters) of the surgical skin incision made during the procedure, measured immediately after wound closure.
Time frame: Intraoperative
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
The duration (in minutes) from the initial skin incision to final wound closure, excluding anesthesia induction and emergence.
Time frame: 7 days after surgery
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.
Time frame: 7 days after surgery
The total count of lymph nodes removed during the lymphadenectomy and confirmed by pathological examination.
Contact information is provided by the study sponsor or research team.
Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
Other
Efficacy and Safety Assessment of Single-port Robotic Radical Gastrectomy for Gastric Cancer: a Phase 2a Trial Based on the IDEAL Framework
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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