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

Yonsei University Health System (YUHS)

Status: Enrolling

Conditions: Gastric Cancer

Treatments: Procedure: Arm I (Assistant-Controlled Laparoscopic Instrumentation); Procedure: Arm II (Assistant-Controlled Laparoscopic Instrumentation)

Study type: Interventional

Funder types: Other

Identifiers

NCT06841484

3-2024-0426

Details and patient eligibility

About

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.

Enrollment: 36 estimated patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

36 participants in 2 patient groups

Assistant-Controlled Group

Experimental group

Description:

The assistant performs vascular clipping using articulating Hemolock clip appliers or Challenger® clip appliers and performs the gastrointestinal anastomosis with an Echelon stapling system.

Treatment:

Procedure: Arm I (Assistant-Controlled Laparoscopic Instrumentation)

Full Robotic Group

Active Comparator group

Description:

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

Treatment:

Procedure: Arm II (Assistant-Controlled Laparoscopic Instrumentation)