Safety and Efficacy of Single Port Laparoscopic Surgery in Colon Cancer
February 2, 2016 updated by: Byung Mo Kang, Kyunghee University Medical Center
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 Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
62
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Seoul, Korea, Republic of, 134-727
- Kyung Hee University School of Medicine, Neo Medical Center
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
No older than 85 years (Child, Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Conventional laparoscopic surgery
|
laparoscopic surgery in which each of the instrument were entered into the abdominal cavity through the multiple port in multiple quadrants of abdomen
|
|
Experimental: Single port laparoscopic surgery
|
laparoscopic surgery in which all the instrument was entered into the abdominal cavity through the single port in the umbilicus
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
rate of intraoperative complication
Time Frame: 1 day
|
1 day
|
|
rate of 30 day morbidity and mortality
Time Frame: 1 month
|
1 month
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
operation time
Time Frame: 1 day
|
operative time
|
1 day
|
|
degree of postoperative pain
Time Frame: 5 days
|
postoperative pain score using visual analog scale (VAS)
|
5 days
|
|
amount of postoperative analgesics usage
Time Frame: 5 days
|
5 days
|
|
|
postoperative functional recovery
Time Frame: 7 days
|
time to first passage of flatus time to start diet
|
7 days
|
|
Duration of postoperative hospital stay
Time Frame: 7 days
|
7 days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Suk Hwan Lee, MD. PhD, Kyung Hee University School of Medicine
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
June 1, 2010
Primary Completion (Actual)
April 1, 2011
Study Completion (Actual)
April 1, 2012
Study Registration Dates
First Submitted
September 15, 2010
First Submitted That Met QC Criteria
September 16, 2010
First Posted (Estimate)
September 17, 2010
Study Record Updates
Last Update Posted (Estimate)
February 3, 2016
Last Update Submitted That Met QC Criteria
February 2, 2016
Last Verified
February 1, 2016
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- KHNMC IRB 2010-007
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.