A Multicenter Prospective Randomized Clinical Trail on the Efficacy of the Single Port Laparoscopic Surgery Compared With Multiport Laparoscopic Surgery
Phase 3
20 Years
85 Years
20 Years
85 Years
Open (Enrolling by invite only)
Both
Colon Neoplasms
Both
Colon Neoplasms
Trial Information
A Multicenter Prospective Randomized Clinical Trail on the Efficacy of the Single Port Laparoscopic Surgery Compared With Multiport Laparoscopic Surgery
This clinical trial is a multicenter prospective randomized trial to compare the single-port
and multi-port laparoscopic colectomy for colon cancer treatment.
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
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
postoperative complications
Outcome Time Frame:
30 days after the operation
Safety Issue:
Yes
Principal Investigator
Jun-Gi Kim, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
The Catholic University of Korea
Authority:
Korea: Institutional Review Board
Study ID:
SPA-2011
NCT ID:
NCT01480128
Start Date:
July 2011
Completion Date:
December 2014
Related Keywords:
- Colon Neoplasms
- Single-port
- Laparoscopy
- colectomy
- Neoplasms
- Colonic Neoplasms
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