Multicenter Single-port Colectomy

This study is enrolling participants by invitation only.
Sponsor:
Information provided by (Responsible Party):
Hyung-Jin Kim, The Catholic University of Korea
ClinicalTrials.gov Identifier:
NCT01480128
First received: November 23, 2011
Last updated: November 25, 2011
Last verified: November 2011

November 23, 2011
November 25, 2011
July 2011
December 2012   (final data collection date for primary outcome measure)
postoperative complications [ Time Frame: 30 days after the operation ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT01480128 on ClinicalTrials.gov Archive Site
oncologic outcomes [ Time Frame: 3 year after the operations ] [ Designated as safety issue: No ]
the number of the retrieved lymph nodes, cancer free margin, recurrence
Same as current
Not Provided
Not Provided
 
Multicenter Single-port Colectomy
A Multicenter Prospective Randomized Clinical Trail on the Efficacy of the Single Port Laparoscopic Surgery Compared With Multiport Laparoscopic Surgery

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.

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

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Colon Neoplasms
  • Procedure: Single-port
    Single-port laparoscopic colon resection
    Other Names:
    • Single-incision
    • SILS
    • Octoport
  • Procedure: Multi-port
    Multi-port laparoscopic colon resection
    Other Name: laparoscopy
  • Active Comparator: Multi-port
    Multi-port laparoscopic colon resection
    Intervention: Procedure: Multi-port
  • Experimental: Single-port
    Single-port laparoscopic colon resection group
    Intervention: Procedure: Single-port
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Enrolling by invitation
388
December 2014
December 2012   (final data collection date for primary outcome measure)

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
Both
20 Years to 85 Years
No
Contact information is only displayed when the study is recruiting subjects
Korea, Republic of
 
NCT01480128
SPA-2011
Yes
Hyung-Jin Kim, The Catholic University of Korea
The Catholic University of Korea
Not Provided
Principal Investigator: Jun-Gi Kim, MD The Catholic University of Korea
The Catholic University of Korea
November 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP