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

February 21, 2025 updated by: In Gyu Kwon, Gangnam Severance Hospital

Clinical Outcomes of Full Robotic Instrumentation Versus Assistant Controlled Laparoscopic Instrumentatin in Robotic Distal Gastrectomy: Randomized Pilot Study

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

36

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: In Gyu Kwon
  • Phone Number: 82-2-2019-4601
  • Email: gsirb@yuhs.ac

Study Locations

  • Korea, Republic of
      • Seoul, Korea, Republic of
        • Recruiting
        • GangnamSeveranceHospital
        • Contact:
          • InGyu Kwon

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Assistant-Controlled Group
The assistant performs vascular clipping using articulating Hemolock clip appliers or Challenger® clip appliers and performs the gastrointestinal anastomosis with an Echelon stapling system.
Procedure: Arm 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.
Active Comparator: Full Robotic Group
The surgeon performs vascular clipping using the robotic arm with Hemolock or Hemoclip appliers and performs anastomosis using a SureForm stapler.
Procedure: Arm 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Average operative time (in minutes).
Time Frame: 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.
At the end of the surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Total cost of consumable surgical materials.
Time Frame: 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.
At the end of the surgery (up to 12 hours)
Quality of Recovery (QoR-15) scores at 72 hours postoperatively.
Time Frame: 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.
72 hours postoperatively
Time to first flatus and bowel movement.
Time Frame: 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.
Up to 1 month after surgery
Postoperative laboratory markers (e.g., CRP, WBC).
Time Frame: 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.
Up to 5 days after surgery
Incidence of postoperative complications.
Time Frame: 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.
Within 30 days postoperatively

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Gangnam Severance Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2025

Primary Completion (Estimated)

January 1, 2026

Study Completion (Estimated)

March 31, 2026

Study Registration Dates

First Submitted

February 17, 2025

First Submitted That Met QC Criteria

February 21, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

February 21, 2025

Last Verified

February 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 3-2024-0426

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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