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

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
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

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
We judged the success when there is no residual stone in the intravenous pyelogram at 12 weeks postoperatively
intravenous pyelogram at 12 weeks postoperatively

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
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
Retrospective review of data

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Seoul National University Hospital

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

Keywords

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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