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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01042743
First Posted: January 6, 2010
Last Update Posted: December 20, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Gyu-Seog Choi, Kyungpook National University
  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 (Investigator)
Primary Purpose: Treatment

Further study details as provided by Gyu-Seog Choi, Kyungpook National University:

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

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

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

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01042743


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

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
First Submitted: January 5, 2010
First Posted: January 6, 2010
Last Update Posted: December 20, 2011
Last Verified: December 2011

Keywords provided by Gyu-Seog Choi, 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