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Safety and Efficacy of Single Port Laparoscopic Surgery in Colon Cancer

Primary Purpose

Colon Cancer

Status
Completed
Phase
Phase 1
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Single port laparoscopic surgery
Conventional laparoscopic surgery
Sponsored by
Kyunghee University Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Colon Cancer

Eligibility Criteria

undefined - 85 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Kyung Hee University School of Medicine, Neo Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Single port laparoscopic surgery

Conventional laparoscopic surgery

Arm Description

Outcomes

Primary Outcome Measures

rate of intraoperative complication
rate of 30 day morbidity and mortality

Secondary Outcome Measures

operation time
operative time
degree of postoperative pain
postoperative pain score using visual analog scale (VAS)
amount of postoperative analgesics usage
postoperative functional recovery
time to first passage of flatus time to start diet
Duration of postoperative hospital stay

Full Information

First Posted
September 15, 2010
Last Updated
February 2, 2016
Sponsor
Kyunghee University Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT01203969
Brief Title
Safety and Efficacy of Single Port Laparoscopic Surgery in Colon Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
February 2016
Overall Recruitment Status
Completed
Study Start Date
June 2010 (undefined)
Primary Completion Date
April 2011 (Actual)
Study Completion Date
April 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Kyunghee University Medical Center

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colon Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
62 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Single port laparoscopic surgery
Arm Type
Experimental
Arm Title
Conventional laparoscopic surgery
Arm Type
Active Comparator
Intervention Type
Procedure
Intervention Name(s)
Single port laparoscopic surgery
Intervention Description
laparoscopic surgery in which all the instrument was entered into the abdominal cavity through the single port in the umbilicus
Intervention Type
Procedure
Intervention Name(s)
Conventional laparoscopic surgery
Intervention Description
laparoscopic surgery in which each of the instrument were entered into the abdominal cavity through the multiple port in multiple quadrants of abdomen
Primary Outcome Measure Information:
Title
rate of intraoperative complication
Time Frame
1 day
Title
rate of 30 day morbidity and mortality
Time Frame
1 month
Secondary Outcome Measure Information:
Title
operation time
Description
operative time
Time Frame
1 day
Title
degree of postoperative pain
Description
postoperative pain score using visual analog scale (VAS)
Time Frame
5 days
Title
amount of postoperative analgesics usage
Time Frame
5 days
Title
postoperative functional recovery
Description
time to first passage of flatus time to start diet
Time Frame
7 days
Title
Duration of postoperative hospital stay
Time Frame
7 days

10. Eligibility

Sex
All
Maximum Age & Unit of Time
85 Years
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Suk Hwan Lee, MD. PhD
Organizational Affiliation
Kyung Hee University School of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kyung Hee University School of Medicine, Neo Medical Center
City
Seoul
ZIP/Postal Code
134-727
Country
Korea, Republic of

12. IPD Sharing Statement

Citations:
PubMed Identifier
28061037
Citation
Kang BM, Park SJ, Lee KY, Lee SH. Single-Port Laparoscopic Surgery Can Be Performed Safely and Appropriately for Colon Cancer: Short-Term Results of a Pilot Randomized Controlled Trial. J Laparoendosc Adv Surg Tech A. 2017 May;27(5):501-509. doi: 10.1089/lap.2016.0467. Epub 2017 Jan 6.
Results Reference
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Safety and Efficacy of Single Port Laparoscopic Surgery in Colon Cancer

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