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Safety and Efficacy of Single Port Laparoscopic Surgery in Colon Cancer

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ClinicalTrials.gov Identifier: NCT01203969
Recruitment Status : Completed
First Posted : September 17, 2010
Last Update Posted : February 3, 2016
Sponsor:
Information provided by (Responsible Party):
Byung Mo Kang, Kyunghee University Medical Center

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.

Condition or disease Intervention/treatment Phase
Colon Cancer Procedure: Single port laparoscopic surgery Procedure: Conventional laparoscopic surgery Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 62 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Study Start Date : June 2010
Actual Primary Completion Date : April 2011
Actual Study Completion Date : April 2012

Arm Intervention/treatment
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




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

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

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

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

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


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Ages Eligible for Study:   up to 85 Years   (Child, Adult, Older Adult)
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

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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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 Posted: September 17, 2010    Key Record Dates
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