The Clinical Study of Making the Evidence With Application of Da Vinci-Robot Assisted Low Anterior Resection in Rectal Cancer
May 17, 2010 updated by: Yonsei University
The clinical study of making the evidence with application of Da vinci-Robot assisted low anterior resection in rectal cancer
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Actual)
69
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
41 years to 71 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
The patients who visit Severance Hospital for rectal cancer
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Case-Control
- Time Perspectives: Retrospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
robotic surgery group
|
|
|
laparoscopic surgery group
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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
|
1 month
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
The difference in 3 months between two surgical methods in tems of Sexual function.
Time Frame: 3 months
|
3 months
|
|
The serial change of Bladder and sexual function according to times, in each operation method.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Nam Kyu Kim, Department of Surgery, Yonsei University College of Medicine, Seoul, Korea
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
June 1, 2009
Primary Completion (Actual)
March 1, 2010
Study Completion (Actual)
March 1, 2010
Study Registration Dates
First Submitted
May 10, 2010
First Submitted That Met QC Criteria
May 17, 2010
First Posted (Estimate)
May 18, 2010
Study Record Updates
Last Update Posted (Estimate)
May 18, 2010
Last Update Submitted That Met QC Criteria
May 17, 2010
Last Verified
May 1, 2010
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 4-2009-0210
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.