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

NCT06841484 | Recruiting

• 1 other identifier: 3-2024-0426
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

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.

Conditions

Gastric Cancer

Outcome Measures

Primary Outcomes (1)

• Average operative time (in minutes).

  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 Outcomes (5)

• Total cost of consumable surgical materials.

  At the end of the surgery (up to 12 hours)

• Quality of Recovery (QoR-15) scores at 72 hours postoperatively.

  72 hours postoperatively

• Time to first flatus and bowel movement.

  Up to 1 month after surgery

• Postoperative laboratory markers (e.g., CRP, WBC).

  Up to 5 days after surgery

• Incidence of postoperative complications.

  Within 30 days postoperatively

Study Arms (2)

Assistant-Controlled Group

EXPERIMENTAL

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)

Full Robotic Group

ACTIVE COMPARATOR

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)

Interventions

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.

Assistant-Controlled Group

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.

Full Robotic Group

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Gangnam Severance Hospital: lead

Study Sites (1)

GangnamSeveranceHospital

Seoul, South Korea

RECRUITING

MeSH Terms

Conditions

Stomach Neoplasms

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases

Central Study Contacts

In Gyu Kwon

CONTACT

82-2-2019-4601; gsirb@yuhs.ac

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: Single Blind Randomized controlled

Study Record Dates

• First Submitted: February 17, 2025
• First Posted: February 24, 2025
• Study Start: February 1, 2025
• Primary Completion: January 1, 2026
• Study Completion: March 31, 2026
• Last Updated: February 24, 2025

Record last verified: 2025-02

Locations

KR (1)