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

NCT ID: NCT01042743

Last Updated: 2011-12-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-01-31

Study Completion Date

2011-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Colon Cancer

Keywords

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colon cancer robot laparoscopy primary, right-side colon cancer robot-assisted surgery

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Investigators

Study Groups

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RAP

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

Group Type EXPERIMENTAL

robot-assisted surgery

Intervention Type PROCEDURE

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

LAP

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

Group Type ACTIVE_COMPARATOR

laparoscopic right-hemicolectomy

Intervention Type PROCEDURE

Conventional laparoscopic procedures

Interventions

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robot-assisted surgery

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

Intervention Type PROCEDURE

laparoscopic right-hemicolectomy

Conventional laparoscopic procedures

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Kyungpook National University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Gyu-Seog Choi

Colorectal Cancer Center

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Kyungpook National University Hospital

Daegu, , South Korea

Site Status

Countries

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South Korea

References

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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.

Reference Type DERIVED
PMID: 36594748 (View on PubMed)

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.

Reference Type DERIVED
PMID: 22864881 (View on PubMed)

Other Identifiers

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KNUHCRC001

Identifier Type: -

Identifier Source: org_study_id