NCT01042743

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Jan 2010

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2010

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

January 5, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 6, 2010

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2011

Completed
Last Updated

December 20, 2011

Status Verified

December 1, 2011

Enrollment Period

1.9 years

First QC Date

January 5, 2010

Last Update Submit

December 18, 2011

Conditions

Keywords

colon cancerrobotlaparoscopyprimary, right-side colon cancerrobot-assisted surgery

Outcome Measures

Primary Outcomes (1)

  • surgical quality based on pathological examination

    during perioperative period (1-30 days after operation)

Secondary Outcomes (1)

  • complication

    during perioperative period ( 1-30 days after primary operation)

Study Arms (2)

RAP

EXPERIMENTAL

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

Procedure: robot-assisted surgery

LAP

ACTIVE COMPARATOR

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

Procedure: laparoscopic right-hemicolectomy

Interventions

da Vinci surgical system® (Intuitive Surgical, Sunnyvale, CA, USA)

RAP

Conventional laparoscopic procedures

LAP

Eligibility Criteria

Age20 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • tumor with obstruction
  • tumor with perforation
  • clinically advanced tumor (T4 stage)
  • tumor with distant metastases
  • synchronous tumor

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kyungpook National University Hospital

Daegu, 700-721, South Korea

Location

Related Publications (2)

  • Park JS, Lee SM, Choi GS, Park SY, Kim HJ, Song SH, Min BS, Kim NK, Kim SH, Lee KY. Comparison of Laparoscopic Versus Robot-Assisted Surgery for Rectal Cancers: The COLRAR Randomized Controlled Trial. Ann Surg. 2023 Jul 1;278(1):31-38. doi: 10.1097/SLA.0000000000005788. Epub 2023 Jan 3.

  • 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.

MeSH Terms

Conditions

Colonic Neoplasms

Interventions

Robotic Surgical Procedures

Condition Hierarchy (Ancestors)

Colorectal NeoplasmsIntestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal Diseases

Intervention Hierarchy (Ancestors)

Surgery, Computer-AssistedSurgical Procedures, OperativeRoboticsAutomationTechnologyTechnology, Industry, and Agriculture

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Colorectal Cancer Center

Study Record Dates

First Submitted

January 5, 2010

First Posted

January 6, 2010

Study Start

January 1, 2010

Primary Completion

December 1, 2011

Study Completion

December 1, 2011

Last Updated

December 20, 2011

Record last verified: 2011-12

Locations