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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:
ClinicalTrials.gov Identifier:
NCT01125111
First Posted: May 18, 2010
Last Update Posted: May 18, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Yonsei University
  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

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 ]
    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 ]
  • The serial change of Bladder and sexual function according to times, in each operation method.

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

Information from the National Library of Medicine

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Ages Eligible for Study:   45 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01125111


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

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
First Submitted: May 10, 2010
First Posted: May 18, 2010
Last Update Posted: May 18, 2010
Last Verified: May 2010

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