Comparison of Full Robotic Instrumentation and Assistant-Controlled Laparoscopic Instrumentation in Robotic Distal Gastrectomy

Not Applicable

Recruiting

• Conditions: Gastric Cancer

• Registration Number: NCT06841484
• Lead Sponsor: Gangnam Severance Hospital

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-02
• Study Start: 2025-02-01
• Study First Submitted: 2025-02-17
• Study First Submitted QC: 2025-02-21
• Last Update Submitted: 2025-02-21
• Study First Posted: 2025-02-24
• Last Update Posted: 2025-02-24
• Primary Completion: 2026-01-01
• Study Completion: 2026-03-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 36

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.
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.
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.
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.

Trial Locations

Locations (1)

GangnamSeveranceHospital; 🇰🇷 Seoul, Korea, Republic of