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NCT Number: NCT06841484

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

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.

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Key information

Conditions

Gastric Cancer Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Neoplasms Neoplasms by Site Stomach Diseases Stomach Neoplasms

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

GangnamSeveranceHospital

Seoul, South Korea

Location status: Recruiting

Location contact

InGyu Kwon

CONTACT

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients with histologically confirmed gastric adenocarcinoma prior to surgery.
  • Patients who have undergone a complete (R0) resection.
  • Patients with an ASA (American Society of Anesthesiologists) score of 3 or below.
  • Patients undergoing robotic radical distal gastrectomy.

Exclusion criteria

  • Patients under 19 years of age.
  • Patients who have received preoperative chemotherapy or radiotherapy.
  • Patients diagnosed with stage IV gastric cancer due to distant metastasis.
  • Patients diagnosed with malignancies other than gastric cancer.
  • Patients scheduled to undergo total gastrectomy.
  • Patients requiring total omentectomy.

Treatment and study plan

Arm I (Assistant-Controlled Laparoscopic Instrumentation)

Procedure

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.

Arm II (Assistant-Controlled Laparoscopic Instrumentation)

Procedure

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

In Gyu Kwon

CONTACT

[email protected]

82-2-2019-4601

Sponsors and collaborators

Lead sponsor

Gangnam Severance Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Feb 24, 2025
Registry last updated
Feb 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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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