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

Primary Purpose

Colon Cancer

Status
Completed
Phase
Phase 2
Locations
Korea, Republic of
Study Type
Interventional
Intervention
robot-assisted surgery
laparoscopic right-hemicolectomy
Sponsored by
Kyungpook National University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Colon Cancer focused on measuring colon cancer, robot, laparoscopy, primary, right-side colon cancer, robot-assisted surgery

Eligibility Criteria

20 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Kyungpook National University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

RAP

LAP

Arm Description

individuals who underwent robot-assisted surgery for primary right-sied colon cancer

Individuals who underwent laparoscopic surgery for primary right-side colon cancer

Outcomes

Primary Outcome Measures

surgical quality based on pathological examination

Secondary Outcome Measures

complication

Full Information

First Posted
January 5, 2010
Last Updated
December 18, 2011
Sponsor
Kyungpook National University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01042743
Brief Title
Laparoscopic Surgery Versus Robot Surgery for Right-side Colon Cancer: Short-term Outcome of a Randomised Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
December 2011
Overall Recruitment Status
Completed
Study Start Date
January 2010 (undefined)
Primary Completion Date
December 2011 (Actual)
Study Completion Date
December 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Kyungpook National University Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colon Cancer
Keywords
colon cancer, robot, laparoscopy, primary, right-side colon cancer, robot-assisted surgery

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
80 (Actual)

8. Arms, Groups, and Interventions

Arm Title
RAP
Arm Type
Experimental
Arm Description
individuals who underwent robot-assisted surgery for primary right-sied colon cancer
Arm Title
LAP
Arm Type
Active Comparator
Arm Description
Individuals who underwent laparoscopic surgery for primary right-side colon cancer
Intervention Type
Procedure
Intervention Name(s)
robot-assisted surgery
Intervention Description
da Vinci surgical system® (Intuitive Surgical, Sunnyvale, CA, USA)
Intervention Type
Procedure
Intervention Name(s)
laparoscopic right-hemicolectomy
Intervention Description
Conventional laparoscopic procedures
Primary Outcome Measure Information:
Title
surgical quality based on pathological examination
Time Frame
during perioperative period (1-30 days after operation)
Secondary Outcome Measure Information:
Title
complication
Time Frame
during perioperative period ( 1-30 days after primary operation)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
Kyungpook National University Hospital
City
Daegu
ZIP/Postal Code
700-721
Country
Korea, Republic of

12. IPD Sharing Statement

Citations:
PubMed Identifier
22864881
Citation
Park JS, Choi GS, Park SY, Kim HJ, Ryuk JP. Randomized clinical trial of robot-assisted versus standard laparoscopic right colectomy. Br J Surg. 2012 Sep;99(9):1219-26. doi: 10.1002/bjs.8841.
Results Reference
derived

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

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