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

Phase 1

Completed

• Conditions: Gastric Cancer
• Interventions: Procedure: Reduced port robotic distal gastrectomy

• Registration Number: NCT02347956
• Lead Sponsor: Yonsei University

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-01
• Study First Submitted: 2015-01-20
• Study First Submitted QC: 2015-01-27
• Study First Posted: 2015-01-28
• Status Verified: 2015-11
• Primary Completion: 2015-11
• Study Completion: 2015-11
• Last Update Submitted: 2015-11-12
• Last Update Posted: 2015-11-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 19

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

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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)

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Reduced port group	Reduced port robotic distal gastrectomy	-

Primary Outcome Measures

Name	Time	Method
morbidity	30 days

Secondary Outcome Measures

Name	Time	Method
mortality	30 days

Trial Locations

Locations (1)

Severance hospital; 🇰🇷 Seoul, Korea, Republic of