Safety and Efficacy of Single Port Laparoscopic Surgery in Colon Cancer

This study is enrolling participants by invitation only.
Sponsor:
Information provided by:
Kyunghee University Medical Center
ClinicalTrials.gov Identifier:
NCT01203969
First received: September 15, 2010
Last updated: September 16, 2010
Last verified: September 2010
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by Kyunghee University Medical Center:

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

Secondary Outcome Measures:
  • operation time [ Time Frame: 1 day ] [ Designated as safety issue: No ]
    operative time

  • degree of postoperative pain [ Time Frame: 5 days ] [ Designated as safety issue: No ]
    postoperative pain score using visual analog scale (VAS)

  • amount of postoperative analgesics usage [ Time Frame: 5 days ] [ Designated as safety issue: No ]
  • postoperative functional recovery [ Time Frame: 7 days ] [ Designated as safety issue: No ]
    time to first passage of flatus time to start diet

  • Duration of postoperative hospital stay [ Time Frame: 7 days ] [ Designated as safety issue: No ]

Estimated Enrollment: 60
Study Start Date: June 2010
Estimated Study Completion Date: March 2011
Estimated Primary Completion Date: March 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

Ages Eligible for Study:   up to 85 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Suk Hwan Lee, Kyung Hee University School of Medicine
ClinicalTrials.gov Identifier: NCT01203969     History of Changes
Other Study ID Numbers: KHNMC IRB 2010-007
Study First Received: September 15, 2010
Last Updated: September 16, 2010
Health Authority: South Korea: Korea Food and Drug Administration (KFDA)

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

ClinicalTrials.gov processed this record on August 20, 2014