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

  • Korea, Republic of
      • 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
Procedure: 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
Procedure: 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.

Sponsor

Kyunghee University Medical Center

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.

General Publications

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.

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