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NCT01480128 Clinical Trial

Multicenter Single-port Colectomy RCT

Colon Neoplasms Clinical Trial

— SIMPLE  

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

Clinical Trial Details — Status: Approved for marketing

Administrative data
NCT number NCT01480128
Other study ID # SPA-2011
Secondary ID
Status Approved for marketing
Phase
First received
Last updated

Study information
Verified date June 2020
Source The Catholic University of Korea
Contact n/a
Is FDA regulated No
Health authority
Study type Expanded Access

Clinical Trial 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.

Description:

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

Recruitment information / eligibility
Status Approved for marketing
Enrollment 0
Est. completion date
Est. primary completion date
Accepts healthy volunteers No
Gender All
Age group 20 Years to 85 Years
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Procedure:
• Single-port
Single-port laparoscopic colon resection
• Multi-port
Multi-port laparoscopic colon resection

Locations
Country Name City State
Korea, Republic of St. Vincent's hospital Suwon

Sponsors (3)
Lead Sponsor Collaborator
The Catholic University of Korea Chonnam National University, Kyunghee University

Country where clinical trial is conducted

Korea, Republic of, 

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