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OpenTrials
Completed

NCT Number: NCT02347956

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

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.

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Key information

Age range

20 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Severance hospital

Seoul, 120-752, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

Reduced port robotic distal gastrectomy

Procedure

Primary outcomes

  1. morbidity

    Time frame: 30 days

Secondary outcomes

  1. mortality

    Time frame: 30 days

Sponsors and collaborators

Lead sponsor

Yonsei University

Other

Registry information

Important dates

Study start
2015
Primary completion
2015
Study completion
2015
First posted
Jan 28, 2015
Registry last updated
Nov 16, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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