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Multicenter Single-port Colectomy RCT (SIMPLE)

This study is enrolling participants by invitation only.
Sponsor:
Collaborators:
Kyung Hee University
Chonnam National University
Information provided by (Responsible Party):
Hyung-Jin Kim, The Catholic University of Korea
ClinicalTrials.gov Identifier:
NCT01480128
First received: November 23, 2011
Last updated: October 5, 2015
Last verified: October 2015
  Purpose

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.


Condition Intervention Phase
Colon Neoplasms
Procedure: Single-port
Procedure: Multi-port
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Multicenter Prospective Randomized Clinical Trail on the Efficacy of the Single Port Laparoscopic Surgery Compared With Multiport Laparoscopic Surgery

Further study details as provided by The Catholic University of Korea:

Primary Outcome Measures:
  • postoperative complications [ Time Frame: 30 days after the operation ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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


Estimated Enrollment: 388
Study Start Date: July 2011
Estimated Study Completion Date: December 2017
Estimated Primary Completion Date: December 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Multi-port
Multi-port laparoscopic colon resection
Procedure: Multi-port
Multi-port laparoscopic colon resection
Other Name: laparoscopy
Experimental: Single-port
Single-port laparoscopic colon resection group
Procedure: Single-port
Single-port laparoscopic colon resection
Other Names:
  • Single-incision
  • SILS
  • Octoport

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.
  Eligibility

Ages Eligible for Study:   20 Years to 85 Years   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01480128

Locations
Korea, Republic of
St. Vincent's hospital
Suwon, Korea, Republic of, 442-723
Sponsors and Collaborators
The Catholic University of Korea
Kyung Hee University
Chonnam National University
Investigators
Principal Investigator: Jun-Gi Kim, MD The Catholic University of Korea
  More Information

Responsible Party: Hyung-Jin Kim, MD, PhD, The Catholic University of Korea
ClinicalTrials.gov Identifier: NCT01480128     History of Changes
Other Study ID Numbers: SPA-2011 
Study First Received: November 23, 2011
Last Updated: October 5, 2015
Health Authority: Korea: Institutional Review Board

Keywords provided by The Catholic University of Korea:
Single-port
Laparoscopy
colectomy
Single port
colon cancer
minimally invasive surgery

Additional relevant MeSH terms:
Colonic Neoplasms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases

ClinicalTrials.gov processed this record on December 09, 2016