Safety and Efficacy of Single Port Laparoscopic Surgery in Colon Cancer

Kyung Hee University

Status and phase: Completed; Phase 1

Conditions: Colon Cancer

Treatments: Procedure: Single port laparoscopic surgery; Procedure: Conventional laparoscopic surgery

Study type: Interventional

Funder types: Other

Identifiers

NCT01203969

KHNMC IRB 2010-007

Details and patient eligibility

About

This randomized trial is designed to identify the safety and efficacy of single port laparoscopic surgery in colon cancer compared with conventional laparoscopic surgery.

Enrollment: 62 patients

Sex: All

Ages: Under 85 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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62 participants in 2 patient groups

Single port laparoscopic surgery

Experimental group

Treatment:

Procedure: Single port laparoscopic surgery

Conventional laparoscopic surgery

Active Comparator group

Treatment:

Procedure: Conventional laparoscopic surgery