Gastric Cancer
Conditions
Brief summary
This pilot study aims to provide valuable insights into the optimal surgical approach for robotic distal gastrectomy. By comparing full robotic procedures with assistant-controlled techniques, the results may guide future practice, enhancing surgical efficiency, reducing costs, and improving patient outcomes.
Interventions
PROCEDUREArm I (Assistant-Controlled Laparoscopic Instrumentation)
In this group, robotic distal gastrectomy is performed with assistant-controlled laparoscopic instrumentation. The assistant conducts vascular clipping using articulating Hemolock clip appliers (Livsmed) or Challenger® clip appliers (B.Braun). For gastrointestinal anastomosis, the assistant operates an Echelon stapling system (Johnson & Johnson) via the assistant port. The surgeon controls the robotic console for all other surgical steps. This method utilizes a hybrid approach, combining robotic precision with laparoscopic efficiency.
PROCEDUREArm II (Assistant-Controlled Laparoscopic Instrumentation)
In this group, all surgical steps, including vascular clipping and anastomosis, are performed using the robotic system. The surgeon utilizes the Da Vinci Xi system and switches robotic instruments as needed. Vascular clipping is performed with robotic Hemolock or Hemoclip appliers, and anastomosis is conducted using the SureForm robotic stapler. This fully robotic technique eliminates laparoscopic assistance and utilizes only robotic arms for the entire procedure. Both groups follow the same postoperative care protocols, including standardized pain management and recovery assessments.
Sponsors
Gangnam Severance Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Intervention model description
Single Blind Randomized controlled
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Patients with histologically confirmed gastric adenocarcinoma prior to surgery. 2. Patients who have undergone a complete (R0) resection. 3. Patients with an ASA (American Society of Anesthesiologists) score of 3 or below. 4. Patients undergoing robotic radical distal gastrectomy.
Exclusion criteria
1. Patients under 19 years of age. 2. Patients who have received preoperative chemotherapy or radiotherapy. 3. Patients diagnosed with stage IV gastric cancer due to distant metastasis. 4. Patients diagnosed with malignancies other than gastric cancer. 5. Patients scheduled to undergo total gastrectomy. 6. Patients requiring total omentectomy.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Average operative time (in minutes). | At the end of the surgery | The primary outcome is the average operative time (in minutes) from skin incision to skin closure. This measurement will compare surgical efficiency between the assistant-controlled laparoscopic instrumentation group and the full robotic instrumentation group. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time to first flatus and bowel movement. | Up to 1 month after surgery | The time taken for the patient to pass gas and have a bowel movement will be recorded to assess postoperative gastrointestinal recovery. |
| Total cost of consumable surgical materials. | At the end of the surgery (up to 12 hours) | The total cost of surgical consumables, including robotic instruments, staplers, clips, and other disposable materials used during the procedure, will be calculated from the surgical expense records. |
| Quality of Recovery (QoR-15) scores at 72 hours postoperatively. | 72 hours postoperatively | The total cost of surgical consumables, including robotic instruments, staplers, clips, and other disposable materials used during the procedure, will be calculated from the surgical expense records. |
| Postoperative laboratory markers (e.g., CRP, WBC). | Up to 5 days after surgery | Inflammatory markers, including C-reactive protein (CRP) and white blood cell (WBC) counts, will be measured from blood samples to evaluate the patient's inflammatory response. |
| Incidence of postoperative complications. | Within 30 days postoperatively | The incidence of postoperative complications, including infections, bleeding, anastomotic leakage, and other surgical site issues, will be recorded and classified according to the Clavien-Dindo classification. |
Countries
South Korea
Contacts
Primary ContactIn Gyu Kwon
Outcome results
None listed