Laparoscopic Surgery Versus Robot Surgery for Right-side Colon Cancer: Short-term Outcome of a Randomised Clinical Trial

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Gyu-Seog Choi, Kyungpook National University
ClinicalTrials.gov Identifier:
NCT01042743
First received: January 5, 2010
Last updated: December 18, 2011
Last verified: December 2011
  Purpose

The recent introduction of robotic surgical system has revolutionized the field of minimally invasive surgery. The investigators hypothesized that adoption of a robotic surgical system for patients with right-side colon cancer seems appealing because This system provides high-definition three-dimensional vision, eliminates physiologic tremor, and better ergonomics. This randomized controlled trial was designed to determine the safety and efficacy of robotic right hemicolectomy in comparison with laparoscopic right hemicolectomy.


Condition Intervention Phase
Colon Cancer
Procedure: robot-assisted surgery
Procedure: laparoscopic right-hemicolectomy
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by Kyungpook National University:

Primary Outcome Measures:
  • surgical quality based on pathological examination [ Time Frame: during perioperative period (1-30 days after operation) ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • complication [ Time Frame: during perioperative period ( 1-30 days after primary operation) ] [ Designated as safety issue: Yes ]

Enrollment: 80
Study Start Date: January 2010
Study Completion Date: December 2011
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: RAP
individuals who underwent robot-assisted surgery for primary right-sied colon cancer
Procedure: robot-assisted surgery
da Vinci surgical system® (Intuitive Surgical, Sunnyvale, CA, USA)
Active Comparator: LAP
Individuals who underwent laparoscopic surgery for primary right-side colon cancer
Procedure: laparoscopic right-hemicolectomy
Conventional laparoscopic procedures

  Eligibility

Ages Eligible for Study:   20 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • primary cancer
  • right-side located tumor (from cecum to proximal transverse colon)

Exclusion Criteria:

  • tumor with obstruction
  • tumor with perforation
  • clinically advanced tumor (T4 stage)
  • tumor with distant metastases
  • synchronous tumor
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01042743

Locations
Korea, Republic of
Kyungpook National University Hospital
Daegu, Korea, Republic of, 700-721
Sponsors and Collaborators
Kyungpook National University
  More Information

No publications provided by Kyungpook National University

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Gyu-Seog Choi, Colorectal Cancer Center, Kyungpook National University
ClinicalTrials.gov Identifier: NCT01042743     History of Changes
Other Study ID Numbers: KNUHCRC001
Study First Received: January 5, 2010
Last Updated: December 18, 2011
Health Authority: South Korea: Institutional Review Board

Keywords provided by Kyungpook National University:
colon cancer
robot
laparoscopy
primary, right-side colon cancer
robot-assisted surgery

Additional relevant MeSH terms:
Colonic Neoplasms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases

ClinicalTrials.gov processed this record on August 27, 2014