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Safety and Efficacy of Single Port Laparoscopic Surgery in Colon Cancer

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01203969
First Posted: September 17, 2010
Last Update Posted: February 3, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Byung Mo Kang, Kyunghee University Medical Center
  Purpose
This randomized trial is designed to identify the safety and efficacy of single port laparoscopic surgery in colon cancer compared with conventional laparoscopic surgery.

Condition Intervention Phase
Colon Cancer Procedure: Single port laparoscopic surgery Procedure: Conventional laparoscopic surgery Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment

Further study details as provided by Byung Mo Kang, Kyunghee University Medical Center:

Primary Outcome Measures:
  • rate of intraoperative complication [ Time Frame: 1 day ]
  • rate of 30 day morbidity and mortality [ Time Frame: 1 month ]

Secondary Outcome Measures:
  • operation time [ Time Frame: 1 day ]
    operative time

  • degree of postoperative pain [ Time Frame: 5 days ]
    postoperative pain score using visual analog scale (VAS)

  • amount of postoperative analgesics usage [ Time Frame: 5 days ]
  • postoperative functional recovery [ Time Frame: 7 days ]
    time to first passage of flatus time to start diet

  • Duration of postoperative hospital stay [ Time Frame: 7 days ]

Enrollment: 62
Study Start Date: June 2010
Study Completion Date: April 2012
Primary Completion Date: April 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
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

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 85 Years   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01203969


Locations
Korea, Republic of
Kyung Hee University School of Medicine, Neo Medical Center
Seoul, Korea, Republic of, 134-727
Sponsors and Collaborators
Kyunghee University Medical Center
Investigators
Principal Investigator: Suk Hwan Lee, MD. PhD Kyung Hee University School of Medicine
  More Information

Responsible Party: Byung Mo Kang, Clinical Assistant Professor, Kyunghee University Medical Center
ClinicalTrials.gov Identifier: NCT01203969     History of Changes
Other Study ID Numbers: KHNMC IRB 2010-007
First Submitted: September 15, 2010
First Posted: September 17, 2010
Last Update Posted: February 3, 2016
Last Verified: February 2016

Additional relevant MeSH terms:
Colonic Neoplasms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases