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Clinical Trials/NCT01203969
NCT01203969CompletedPhase 1

Safety and Efficacy of Single Port Laparoscopic Surgery in Colon Cancer

Kyunghee University Medical Center1 site in 1 country62 target enrollmentStarted: June 1, 2010Last updated:
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Conditions
Interventions

Trial Snapshot

Phase
Phase 1
Status
Completed
Enrollment
62
Locations
1
Primary Endpoint
rate of 30 day morbidity and mortality
Study OverviewStudy DesignEligibility CriteriaArms & InterventionsOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study 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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
— to 85 Years (Child, Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Arms & Interventions

Single port laparoscopic surgery

Experimental

Intervention: Single port laparoscopic surgery (Procedure)

Conventional laparoscopic surgery

Active Comparator

Intervention: Conventional laparoscopic surgery (Procedure)

Outcomes

Primary Outcomes

rate of 30 day morbidity and mortality

Time Frame: 1 month

rate of intraoperative complication

Time Frame: 1 day

Secondary Outcomes

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

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Byung Mo Kang

Clinical Assistant Professor

Kyunghee University Medical Center

Study Sites (1)

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