We updated the design of this site on September 25th. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

Role of Flexible Cystoscopy in Laparoscopic Stone Surgery

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01277198
First Posted: January 14, 2011
Last Update Posted: January 14, 2011
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:
Seoul National University Hospital
  Purpose
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.

Condition
Kidney Calculi; Ureteral Calculi

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Retrospective
Official Title: The Role of Flexible Cystoscopy in Laparoscopic Stone Surgery: a Single Surgeon Experience

Further study details as provided by Seoul National University Hospital:

Primary Outcome Measures:
  • the presence of residual stones [ Time Frame: intravenous pyelogram at 12 weeks postoperatively ]
    We judged the success when there is no residual stone in the intravenous pyelogram at 12 weeks postoperatively


Secondary Outcome Measures:
  • 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 ]
    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


Enrollment: 80
Study Start Date: January 2005
Study Completion Date: August 2010
Primary Completion Date: August 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts
surgery without using a flexible cystoscopy
surgery without using a flexible cystoscopy: patients who did not undergo a flexible cystoscopy during laparoscopic stone surgery
surgery with using a flexible cystoscopy
surgery with using a flexible cystoscopy: patients who underwent a flexible cystoscopy during laparoscopic stone surgery

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.
  Eligibility

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   20 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Criteria

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
  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): NCT01277198


Locations
Korea, Republic of
Seoul National University Boramae Hospital
Seoul, Korea, Republic of
Sponsors and Collaborators
Seoul National University Hospital
Investigators
Principal Investigator: Sung Yong Cho, M.D. Seoul National University Hospital
  More Information

Responsible Party: Seoul National University Boramae Hospital
ClinicalTrials.gov Identifier: NCT01277198     History of Changes
Other Study ID Numbers: lapastone
flexible cysto in laparo
First Submitted: January 13, 2011
First Posted: January 14, 2011
Last Update Posted: January 14, 2011
Last Verified: January 2011

Keywords provided by Seoul National University Hospital:
kidney calculi
ureteral calculi
cystoscopes
laparoscopes

Additional relevant MeSH terms:
Kidney Calculi
Nephrolithiasis
Calculi
Ureteral Calculi
Ureterolithiasis
Pathological Conditions, Anatomical
Kidney Diseases
Urologic Diseases
Urolithiasis
Urinary Calculi
Ureteral Diseases