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Safety and Efficacy of Single Port Laparoscopic Surgery in Colon Cancer

Status
Completed
Phases
Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01203969
Enrollment
62
Registered
2010-09-17
Start date
2010-06-30
Completion date
2012-04-30
Last updated
2016-02-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Colon Cancer

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.

Interventions

PROCEDURESingle port laparoscopic surgery

laparoscopic surgery in which all the instrument was entered into the abdominal cavity through the single port in the umbilicus

laparoscopic surgery in which each of the instrument were entered into the abdominal cavity through the multiple port in multiple quadrants of abdomen

Sponsors

Kyunghee University Medical Center
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
No minimum to 85 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
rate of intraoperative complication1 day
rate of 30 day morbidity and mortality1 month

Secondary

MeasureTime frameDescription
amount of postoperative analgesics usage5 days
operation time1 dayoperative time
Duration of postoperative hospital stay7 days
postoperative functional recovery7 daystime to first passage of flatus time to start diet
degree of postoperative pain5 dayspostoperative pain score using visual analog scale (VAS)

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 27, 2026