- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01277198
Role of Flexible Cystoscopy in Laparoscopic Stone Surgery
January 13, 2011 updated by: Seoul National University Hospital
The Role of Flexible Cystoscopy in Laparoscopic Stone Surgery: a Single Surgeon Experience
Authors want to investigate the usefulness of flexible cystoscopy in performing laparoscopic pyelolithotomies and ureterolithotomies by comparing operative results of a single surgeon's experience.
Study Overview
Status
Completed
Conditions
Detailed Description
Previous trials to increase stone clearance rates have been recently reached using flexible equipment in laparoscopic surgery, however, it is not clear whether using flexible equipment is really helpful in performing pyelolithotomies and the clearance rates using flexible equipment varies 71% to 100%.
Therefore, authors plan to investigate the usefulness of flexible cystoscopy in performing laparoscopic pyelolithotomies and ureterolithotomies by comparing operative results of a single surgeon's experience.
Study Type
Observational
Enrollment (Actual)
80
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Seoul, Korea, Republic of
- Seoul National University Boramae Hospital
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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
20 years to 60 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
71 patients with complex renal stones and large or impacted ureter stones.
All the patients underwent laparoscopic pyelolithotomies with concomitant calyceal stone removal or ureterolithotomy using a flexible cystoscopy or not.
Description
Inclusion Criteria:
- patients with complex renal stones and large or impacted ureter stones
- patients who underwent laparoscopic pyelolithotomies with concomitant calyceal stone removal or ureterolithotomy using a flexible cystoscopy or not
Exclusion Criteria:
- active infection, uncontrolled bleeding tendency, previous abdominal surgery
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 |
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surgery without using a flexible cystoscopy
surgery without using a flexible cystoscopy: patients who did not undergo a flexible cystoscopy during laparoscopic stone surgery
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surgery with using a flexible cystoscopy
surgery with using a flexible cystoscopy: patients who underwent a flexible cystoscopy during laparoscopic stone surgery
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
the presence of residual stones
Time Frame: intravenous pyelogram at 12 weeks postoperatively
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We judged the success when there is no residual stone in the intravenous pyelogram at 12 weeks postoperatively
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intravenous pyelogram at 12 weeks postoperatively
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
stone numbers and sizes, surgical approach, insertion of a DJ ureteral catheter, and use of a flexible cystoscopy, etc
Time Frame: Retrospective review of data
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Preoperative evaluation included a complete history, physical examination, and imaging work-up such as X-ray or computed tomography (CT).
Mean preoperative stone numbers and sizes were evaluated and we also evaluated operative information such as surgical approach, insertion of a DJ ureteral catheter, and use of a flexible cystoscopy
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Retrospective review of data
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Sung Yong Cho, M.D., Seoul National University Hospital
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
January 1, 2005
Primary Completion (Actual)
August 1, 2010
Study Completion (Actual)
August 1, 2010
Study Registration Dates
First Submitted
January 13, 2011
First Submitted That Met QC Criteria
January 13, 2011
First Posted (Estimate)
January 14, 2011
Study Record Updates
Last Update Posted (Estimate)
January 14, 2011
Last Update Submitted That Met QC Criteria
January 13, 2011
Last Verified
January 1, 2011
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- lapastone
- flexible cysto in laparo
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.
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