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Multicenter Single-port Colectomy RCT (SIMPLE)

This study is enrolling participants by invitation only.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01480128
First Posted: November 28, 2011
Last Update Posted: October 6, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
Kyunghee University
Chonnam National University
Information provided by (Responsible Party):
Hyung-Jin Kim, The Catholic University of Korea
November 23, 2011
November 28, 2011
October 6, 2015
July 2011
December 2016   (Final data collection date for primary outcome measure)
postoperative complications [ Time Frame: 30 days after the operation ]
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 ]
the number of the retrieved lymph nodes, cancer free margin, recurrence
Same as current
Not Provided
Not Provided
 
Multicenter Single-port Colectomy RCT
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
Intervention Model: Parallel Assignment
Masking: None (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
Kang BM, Kim HJ, Kye BH, Lee SC, Lee KY, Park SJ, Lee SH, Lim SW, Lee YS, Kim JH, Lee J, Kim MK, Kim JG. Multicenter, randomized single-port versus multiport laparoscopic surgery (SIMPLE) trial in colon cancer: an interim analysis. Surg Endosc. 2017 Sep 15. doi: 10.1007/s00464-017-5842-0. [Epub ahead of print]

*   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 2017
December 2016   (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
Sexes Eligible for Study: All
20 Years to 85 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Korea, Republic of
 
 
NCT01480128
SPA-2011
Yes
Not Provided
Not Provided
Hyung-Jin Kim, The Catholic University of Korea
The Catholic University of Korea
  • Kyunghee University
  • Chonnam National University
Principal Investigator: Jun-Gi Kim, MD The Catholic University of Korea
The Catholic University of Korea
October 2015

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