Laparoscopic Surgery Versus Robot Surgery for Right-side Colon Cancer: Short-term Outcome of a Randomised Clinical Trial

Colon Cancer Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01042743
• Other study ID #: KNUHCRC001
• Status: Completed
• Phase: Phase 2
• First received: January 5, 2010
• Last updated: December 18, 2011
• Start date: January 2010
• Est. completion date: December 2011

Study information

• Verified date: December 2011
• Source: Kyungpook National University
• Contact: n/a
• Is FDA regulated: No
• Health authority: South Korea: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

The recent introduction of robotic surgical system has revolutionized the field of minimally invasive surgery. The investigators hypothesized that adoption of a robotic surgical system for patients with right-side colon cancer seems appealing because This system provides high-definition three-dimensional vision, eliminates physiologic tremor, and better ergonomics. This randomized controlled trial was designed to determine the safety and efficacy of robotic right hemicolectomy in comparison with laparoscopic right hemicolectomy.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: December 2011
• Est. primary completion date: December 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 80 Years

Eligibility

Inclusion Criteria:

• primary cancer

• right-side located tumor (from cecum to proximal transverse colon)

Exclusion Criteria:

• tumor with obstruction

• tumor with perforation

• clinically advanced tumor (T4 stage)

• tumor with distant metastases

• synchronous tumor

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Colon Cancer

Intervention

Procedure:
• robot-assisted surgery
da Vinci surgical system® (Intuitive Surgical, Sunnyvale, CA, USA)
• laparoscopic right-hemicolectomy
Conventional laparoscopic procedures

Locations

Country	Name	City	State
Korea, Republic of	Kyungpook National University Hospital	Daegu

Sponsors (1)

Lead Sponsor	Collaborator
Kyungpook National University

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	surgical quality based on pathological examination		during perioperative period (1-30 days after operation)	Yes
Secondary	complication		during perioperative period ( 1-30 days after primary operation)	Yes