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

NCT ID: NCT06841484

Last Updated: 2025-02-24

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 36 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-02-01
• Study Completion Date: 2026-03-31

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

Arm I (Assistant-Controlled Laparoscopic Instrumentation)

Intervention Type: 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.

Full Robotic Group

The surgeon performs vascular clipping using the robotic arm with Hemolock or Hemoclip appliers and performs anastomosis using a SureForm stapler.

Group Type: ACTIVE_COMPARATOR

Arm II (Assistant-Controlled Laparoscopic Instrumentation)

Intervention Type: 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.

Interventions

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.

Intervention Type: 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.

Intervention Type: PROCEDURE

Eligibility Criteria

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.

• Minimum Eligible Age: 20 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Gangnam Severance Hospital

OTHER

Sponsor Role: lead

Responsible Party

In Gyu Kwon

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

GangnamSeveranceHospital

Seoul, , South Korea

Site Status: RECRUITING

Countries

South Korea

Central Contacts

In Gyu Kwon

Role: CONTACT

gsirb@yuhs.ac

82-2-2019-4601

Facility Contacts

InGyu Kwon

Role: primary

Other Identifiers

3-2024-0426

Identifier Type: -

Identifier Source: org_study_id