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Multicenter Single-port Colectomy RCT (SIMPLE)

Primary Purpose

Colon Neoplasms

Status
Approved for marketing
Phase
Locations
Korea, Republic of
Study Type
Expanded Access
Intervention
Single-port
Multi-port
Sponsored by
The Catholic University of Korea
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an expanded access trial for Colon Neoplasms focused on measuring Single-port, Laparoscopy, colectomy, Single port, colon cancer, minimally invasive surgery

Eligibility Criteria

20 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • St. Vincent's hospital

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
November 23, 2011
Last Updated
June 17, 2020
Sponsor
The Catholic University of Korea
Collaborators
Kyunghee University, Chonnam National University
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1. Study Identification

Unique Protocol Identification Number
NCT01480128
Brief Title
Multicenter Single-port Colectomy RCT
Acronym
SIMPLE
Official Title
A Multicenter Prospective Randomized Clinical Trail on the Efficacy of the Single Port Laparoscopic Surgery Compared With Multiport Laparoscopic Surgery
Study Type
Expanded Access

2. Study Status

Record Verification Date
June 2020
Overall Recruitment Status
Approved for marketing
Study Start Date
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Primary Completion Date
undefined (undefined)
Study Completion Date
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3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The Catholic University of Korea
Collaborators
Kyunghee University, Chonnam National University

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colon Neoplasms
Keywords
Single-port, Laparoscopy, colectomy, Single port, colon cancer, minimally invasive surgery

7. Study Design

8. Arms, Groups, and Interventions

Intervention Type
Procedure
Intervention Name(s)
Single-port
Other Intervention Name(s)
Single-incision, SILS, Octoport
Intervention Description
Single-port laparoscopic colon resection
Intervention Type
Procedure
Intervention Name(s)
Multi-port
Other Intervention Name(s)
laparoscopy
Intervention Description
Multi-port laparoscopic colon resection

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jun-Gi Kim, MD
Organizational Affiliation
The Catholic University of Korea
Official's Role
Principal Investigator
Facility Information:
Facility Name
St. Vincent's hospital
City
Suwon
ZIP/Postal Code
442-723
Country
Korea, Republic of

12. IPD Sharing Statement

Citations:
PubMed Identifier
33141277
Citation
Kang BM, Lee YS, Kim JH, Kim HJ, Lee SC, Kim CW, Lim SW, Kim JG, Lee SH. Quality of life and patient satisfaction after single- and multiport laparoscopic surgery in colon cancer: a multicentre randomised controlled trial (SIMPLE Trial). Surg Endosc. 2021 Nov;35(11):6278-6290. doi: 10.1007/s00464-020-08128-9. Epub 2020 Nov 3.
Results Reference
derived
PubMed Identifier
32209897
Citation
Lee YS, Kim JH, Kim HJ, Lee SC, Kang BM, Kim CW, Lim SW, Lee SH, Kim JG. Short-term Outcomes of Single-port Versus Multiport Laparoscopic Surgery for Colon Cancer: The SIMPLE Multicenter Randomized Clinical Trial. Ann Surg. 2021 Feb 1;273(2):217-223. doi: 10.1097/SLA.0000000000003882.
Results Reference
derived
PubMed Identifier
28916955
Citation
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. 2018 Mar;32(3):1540-1549. doi: 10.1007/s00464-017-5842-0. Epub 2017 Sep 15.
Results Reference
derived

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Multicenter Single-port Colectomy RCT

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