The Safety and Feasibility of Reduced Port Robotic Distal Gastrectomy Using Single-site for Surgical Treatment of Early Gastric Cancer

Yonsei University

Status and phase: Completed; Phase 2; Phase 1

Conditions: Gastric Cancer

Treatments: Procedure: Reduced port robotic distal gastrectomy

Study type: Interventional

Funder types: Other

Identifiers

NCT02347956

4-2014-0864

Details and patient eligibility

About

Gastric cancer is one of the most common malignancy worldwide. Surgical resection of the tumor is the only curative treatment for gastric cancer. However, surgical procedure accompanies postoperative pain and prolonged hospitalization. To lessen the surgical trauma and stress, minimally invasive surgery were introduced. Laparoscopic gastrectomy was accepted as safe and effective alternative to open gastrectomy. Furthermore, reduced port and single port laparoscopic gastrectomy are considered to minimize the surgical trauma during gastrectomy. However, limitations of laparoscopic approach using reduced port includes unergonomic posture of surgeon, physiologic tremor and collision of instruments. To overcome these limitations, robot surgery using novel single-site technology enabled surgeons to perform the surgical procedure reducing the number of trocar from three to one for insertion of scope and two robotic arms. Previously, successful application of single-site technology for cholecystectomy and hysterectomy were reported. The aim of this study is to validate the safety and feasibility of reduced port robotic distal gastrectomy using single-site technology for the surgical treatment of gastric cancer.

Enrollment: 19 patients

Sex: All

Ages: 20 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. A resectable, tissue confirmed adenocarcinoma of the stomach
2. Early gastric cancer curable by distal gastrectomy
3. AGE: 20-70
4. ECOG: 0-1
5. ASA score 1-3
6. A patient who signed the informed consent

Exclusion criteria

1. Advanced lesion with metastatic cancer
2. lesion which is curable by EMR or ESD
3. Previous major abdominal surgery
4. Complicated gastric cancer (obstruction or perforation)
5. History with other primary tumor within 5 year
6. Active other primary tumor
7. Vulnerable subjects (pregnant women, illiterate)

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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19 participants in 1 patient group

Reduced port group

Experimental group

Treatment:

Procedure: Reduced port robotic distal gastrectomy