The Clinical Study of Making the Evidence With Application of Da Vinci-Robot Assisted Low Anterior Resection in Rectal Cancer

Rectal Cancer Clinical Trial

Official title:

The Clinical Study of Making the Evidence With Application of Da Vinci-Robot Assisted Low Anterior Resection in Rectal Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01125111
• Other study ID #: 4-2009-0210
• Status: Completed
• Phase: N/A
• First received: May 10, 2010
• Last updated: May 17, 2010
• Start date: June 2009
• Est. completion date: March 2010

Study information

• Verified date: May 2010
• Source: Yonsei University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Food and Drug Administration
• Study type: Observational

Clinical Trial Summary

The clinical study of making the evidence with application of Da vinci-Robot assisted low anterior resection in rectal cancer

Recruitment information / eligibility

• Status: Completed
• Enrollment: 69
• Est. completion date: March 2010
• Est. primary completion date: March 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 45 Years to 75 Years

Eligibility

Inclusion Criteria:

• 75 > age > 20

• Rectal cancer

• Non-distance metastasis

• Agree with this study

Exclusion Criteria:

• Benign prostate hyperplasia

• Previous history of urinary bladder or prostate gland operation

• Severe erectile dysfunction

• Defined as patients whose erectile scores were less than 10 in a preoperative questionnaire of the International Index of Erectile Function (IIEF)

Study Design

Observational Model: Case Control, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Rectal Cancer
• Rectal Neoplasms

Intervention

Procedure:
• surgery(robot versus laparoscopy)

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Yonsei University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The difference in 1 month between two surgical methods in terms of Bladder function.	The robotic surgery for rectal cancer seemed to be associated with a much earlier recovery of normal voiding and sexual function compared to those of laparoscopic surgery although it needs to be verified by larger prospective comparative studies	1 month	No
Secondary	The difference in 3 months between two surgical methods in tems of Sexual function.		3 months	No
Secondary	The serial change of Bladder and sexual function according to times, in each operation method.			No