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

This study has been completed.
Sponsor:
Information provided by:
Yonsei University
ClinicalTrials.gov Identifier:
NCT01125111
First received: May 10, 2010
Last updated: May 17, 2010
Last verified: May 2010
  Purpose

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


Condition Intervention
Rectal Cancer
Procedure: surgery(robot versus laparoscopy)

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Retrospective
Official Title: The Clinical Study of Making the Evidence With Application of Da Vinci-Robot Assisted Low Anterior Resection in Rectal Cancer

Resource links provided by NLM:


Further study details as provided by Yonsei University:

Primary Outcome Measures:
  • The difference in 1 month between two surgical methods in terms of Bladder function. [ Time Frame: 1 month ] [ Designated as safety issue: No ]
    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


Secondary Outcome Measures:
  • The difference in 3 months between two surgical methods in tems of Sexual function. [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • The serial change of Bladder and sexual function according to times, in each operation method. [ Designated as safety issue: No ]

Enrollment: 69
Study Start Date: June 2009
Study Completion Date: March 2010
Primary Completion Date: March 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
robotic surgery group Procedure: surgery(robot versus laparoscopy)
laparoscopic surgery group Procedure: surgery(robot versus laparoscopy)

  Eligibility

Ages Eligible for Study:   45 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

The patients who visit Severance Hospital for rectal cancer

Criteria

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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01125111

Sponsors and Collaborators
Yonsei University
Investigators
Principal Investigator: Nam Kyu Kim Department of Surgery, Yonsei University College of Medicine, Seoul, Korea
  More Information

No publications provided

Responsible Party: Nam Kyu Kim/Professor, Yonsei University, College of Medicine
ClinicalTrials.gov Identifier: NCT01125111     History of Changes
Other Study ID Numbers: 4-2009-0210
Study First Received: May 10, 2010
Last Updated: May 17, 2010
Health Authority: Korea: Food and Drug Administration

Additional relevant MeSH terms:
Rectal Neoplasms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases
Rectal Diseases

ClinicalTrials.gov processed this record on July 20, 2014