Role of Flexible Cystoscopy in Laparoscopic Stone Surgery

Sponsor
Seoul National University Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT01277198
Collaborator
(none)
80
1
67
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Study Details

Study Description

Brief Summary

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 or Disease Intervention/Treatment Phase

    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 Design

    Study Type:
    Observational
    Actual Enrollment :
    80 participants
    Observational Model:
    Case-Control
    Time Perspective:
    Retrospective
    Official Title:
    The Role of Flexible Cystoscopy in Laparoscopic Stone Surgery: a Single Surgeon Experience
    Study Start Date :
    Jan 1, 2005
    Actual Primary Completion Date :
    Aug 1, 2010
    Actual Study Completion Date :
    Aug 1, 2010

    Arms and Interventions

    Arm Intervention/Treatment
    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

    Outcome Measures

    Primary Outcome Measures

    1. the presence of residual stones [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

    1. stone numbers and sizes, surgical approach, insertion of a DJ ureteral catheter, and use of a flexible cystoscopy, etc [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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    20 Years to 60 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Locations

    Site City State Country Postal Code
    1 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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT01277198
    Other Study ID Numbers:
    • lapastone
    • flexible cysto in laparo
    First Posted:
    Jan 14, 2011
    Last Update Posted:
    Jan 14, 2011
    Last Verified:
    Jan 1, 2011

    Study Results

    No Results Posted as of Jan 14, 2011