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Clinical Trials/NCT01203969
NCT01203969
Completed
Phase 1

Safety and Efficacy of Single Port Laparoscopic Surgery in Colon Cancer

Kyunghee University Medical Center1 site in 1 country62 target enrollmentJune 2010
ConditionsColon Cancer

Overview

Phase
Phase 1
Intervention
Not specified
Conditions
Colon Cancer
Sponsor
Kyunghee University Medical Center
Enrollment
62
Locations
1
Primary Endpoint
rate of 30 day morbidity and mortality
Status
Completed
Last Updated
10 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
June 2010
End Date
April 2012
Last Updated
10 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Byung Mo Kang

Clinical Assistant Professor

Kyunghee University Medical Center

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

Outcomes

Primary Outcomes

rate of 30 day morbidity and mortality

Time Frame: 1 month

rate of intraoperative complication

Time Frame: 1 day

Secondary Outcomes

  • amount of postoperative analgesics usage(5 days)
  • Duration of postoperative hospital stay(7 days)
  • operation time(1 day)
  • degree of postoperative pain(5 days)
  • postoperative functional recovery(7 days)

Study Sites (1)

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