NCT01277198

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2005

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2005

Completed
5.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2010

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

January 13, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 14, 2011

Completed
Last Updated

January 14, 2011

Status Verified

January 1, 2011

Enrollment Period

5.6 years

First QC Date

January 13, 2011

Last Update Submit

January 13, 2011

Conditions

Keywords

kidney calculiureteral calculicystoscopeslaparoscopes

Outcome Measures

Primary Outcomes (1)

  • the presence of residual stones

    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 Outcomes (1)

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

    Retrospective review of data

Study Arms (2)

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

Eligibility Criteria

Age20 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodNon-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.

You may qualify if:

  • 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

You may not qualify if:

  • active infection, uncontrolled bleeding tendency, previous abdominal surgery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seoul National University Boramae Hospital

Seoul, Seoul, South Korea

Location

MeSH Terms

Conditions

Kidney CalculiUreteral Calculi

Condition Hierarchy (Ancestors)

NephrolithiasisKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesUrolithiasisUrinary CalculiMale Urogenital DiseasesCalculiPathological Conditions, AnatomicalPathological Conditions, Signs and SymptomsUreterolithiasisUreteral Diseases

Study Officials

  • Sung Yong Cho, M.D.

    Seoul National University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

January 13, 2011

First Posted

January 14, 2011

Study Start

January 1, 2005

Primary Completion

August 1, 2010

Study Completion

August 1, 2010

Last Updated

January 14, 2011

Record last verified: 2011-01

Locations