Safety and Efficacy of Single Port Laparoscopic Surgery in Colon Cancer

Colon Cancer Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01203969
• Other study ID #: KHNMC IRB 2010-007
• Status: Completed
• Phase: Phase 1
• First received: September 15, 2010
• Last updated: February 2, 2016
• Start date: June 2010
• Est. completion date: April 2012

Study information

• Verified date: February 2016
• Source: Kyunghee University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: South Korea: Korea Food and Drug Administration (KFDA)
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 62
• Est. completion date: April 2012
• Est. primary completion date: April 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 85 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Colon Cancer

Intervention

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
• 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

Locations

Country	Name	City	State
Korea, Republic of	Kyung Hee University School of Medicine, Neo Medical Center	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Kyunghee University Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	rate of intraoperative complication		1 day	Yes
Primary	rate of 30 day morbidity and mortality		1 month	Yes
Secondary	operation time	operative time	1 day	No
Secondary	degree of postoperative pain	postoperative pain score using visual analog scale (VAS)	5 days	No
Secondary	amount of postoperative analgesics usage		5 days	No
Secondary	postoperative functional recovery	time to first passage of flatus time to start diet	7 days	No
Secondary	Duration of postoperative hospital stay		7 days	No