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Recruiting NCT06841484

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

No phase Interventional Gastric Cancer

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Arm I (Assistant-Controlled Laparoscopic Instrumentation), Arm II (Assistant-Controlled Laparoscopic Instrumentation).
Who it may be relevant to
Registry conditions: Gastric Cancer. Basic parameters: from 20 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
South Korea
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

Overview

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

  • 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 roboti
  • 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 po

Primary outcome measures

  • Average operative time (in minutes). [Time frame: At the end of the surgery]
Secondary outcome measures (5)
  • Total cost of consumable surgical materials. [Time frame: 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]
  • Time to first flatus and bowel movement. [Time frame: Up to 1 month after surgery]
  • Postoperative laboratory markers (e.g., CRP, WBC). [Time frame: Up to 5 days after surgery]
  • Incidence of postoperative complications. [Time frame: Within 30 days postoperatively]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Treatment

Study locations

South Korea · 1 center
  • GangnamSeveranceHospital — Seoul

Identifiers

NCT: NCT06841484 · 3-2024-0426

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗