Unknown statusInterventionalNot ApplicableUpdated Feb 13, 2020
Safety and Efficacy of Single Port Laparoscopic Surgery in Colon Cancer | NCT01203969 | Trialant
CompletedInterventionalPhase 1Updated Feb 3, 2016
Safety and Efficacy of Single Port Laparoscopic Surgery in Colon Cancer
ClinicalTrials.gov ID
NCT01203969
Lead Sponsor
Kyunghee University Medical CenterOTHER
Overall Status
Completed
Study Type
Interventional
Phase
Phase 1
Enrollment
62Actual
Last Update Posted
Feb 3, 2016Estimated
Start Date
Jun 2010
Primary Completion Date
Apr 2011Actual
Completion Date
Apr 2012Actual
Brief Summary
This randomized trial is designed to identify the safety and efficacy of single port laparoscopic surgery in colon cancer compared with conventional laparoscopic surgery.
Colon Cancer
Single port laparoscopic surgery
Conventional laparoscopic surgery
Ages Eligible for Study
Child (0-17)Adult (18-64)Older Adult (65+)
Sexes Eligible for Study
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
pathologic proven colon cancer
Exclusion Criteria:
Tumor located in distal transverse colon, splenic flexure, and descending colon
distant metastasis
acute obstruction and/or perforation
associated with FAP or HNPCC
synchronous malignancy
ASA score 3 or 4
pregnancy
no consent
Primary Purpose
Treatment
Allocation
Randomized
Interventional Model
Parallel Assignment
Masking
None (Open Label)
No central contacts
There are no central contacts for this study.
Kyung Hee University School of Medicine, Neo Medical Center