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Clinical Trials/NCT01480128
NCT01480128Approved For MarketingNot Applicable

A Multicenter Prospective Randomized Clinical Trail on the Efficacy of the Single Port Laparoscopic Surgery Compared With Multiport Laparoscopic Surgery

The Catholic University of Korea1 site in 1 countryStarted: November 28, 2011Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Approved For Marketing
Locations
1

Study Overview

Brief Summary

This clinical trial is going to compare the single-port and multi-port laparoscopic colectomy for colon cancer treatment, in terms of safety, efficacy, and cost.

The investigators hypothesize that the single-port laparoscopic colectomy is not inferior to multiport laparoscopic colectomy.

Detailed Description

This clinical trial is a multicenter prospective randomized trial to compare the single-port and multi-port laparoscopic colectomy for colon cancer treatment.

Study Design

Study Type
Expanded Access

Eligibility Criteria

Ages
20 Years to 85 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • colon adenocarcinoma
  • curative resection
  • age : 20 ~ 85

Exclusion Criteria

  • distal transverse colon cancer
  • splenic flexure colon cancer
  • descending colon cancer
  • emergency operation
  • obstruction
  • perforation
  • ASA 3 or 4
  • pregnant woman
  • tumor associated with FAP, HNPCC, or IBD
  • distant metastasis
  • adjacent organ invasion
  • synchronous colorectal cancer
  • other malignancy within last five years

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Hyung-Jin Kim

MD, PhD

The Catholic University of Korea

Study Sites (1)

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