Gastric Cancer Patients Undergoing Gastrectomy
Conditions
Keywords
Single-port robotic, Gastric cancer, Radical Gastrectomy
Brief summary
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.
Detailed description
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.
Interventions
PROCEDURESingle-port Robotic Radical Gastrectomy for Gastric Cancer
Single-port Robotic Radical Gastrectomy for Gastric Cancer
Sponsors
Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* (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.
Exclusion criteria
* (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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Intraoperative adverse events and 30-day postoperative complications | 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. |
| Conversion rate | Intraoperative | Conversion to open or laparotomy surgery due to intraoperative complications , technical difficulties, or inability to successfully complete predefined procedural steps . |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Length of incision | Intraoperative | The total length (in centimeters) of the surgical skin incision made during the procedure, measured immediately after wound closure. |
| Intraoperative Blood Loss | 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. |
| Operative Time | Intraoperative | The duration (in minutes) from the initial skin incision to final wound closure, excluding anesthesia induction and emergence. |
| Postoperative Length of Hospital Stay | 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. |
| Number of Lymph Nodes Harvested | 7 days after surgery | The total count of lymph nodes removed during the lymphadenectomy and confirmed by pathological examination. |
Countries
China
Contacts
CONTACTFan Li MD
Outcome results
None listed