Kidney Calculi; Ureteral CalculiNCT01277198
Role of Flexible Cystoscopy in Laparoscopic Stone Surgery
An observational study of Kidney Calculi; Ureteral Calculi, run by Seoul National University Hospital at 1 site in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 60 years
- Conditions the study is for
- Kidney Calculi; Ureteral Calculi
- How many people
- 80 participants
- Where
- 1 siteSouth Korea
- Study dates
- Jan 2005to Aug 2010
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 60 years
- All sexes
- No healthy volunteers
- Adult
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.
Who may be able to join
- 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
Who cannot join
- active infection, uncontrolled bleeding tendency, previous abdominal surgery
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Kidney Calculi; Ureteral Calculi
- Keywords
- kidney calculi, ureteral calculi, cystoscopes, laparoscopes
- Medical subject headings
- Kidney Calculi, Ureteral Calculi
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
the presence of residual stones
We judged the success when there is no residual stone in the intravenous pyelogram at 12 weeks postoperatively
Measured: 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
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
Measured: Retrospective review of data
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2011 (estimated)
- Study startJan 2005
- Primary completionAug 2010
- Study completionAug 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Kidney Calculi; Ureteral CalculiStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Sung Yong Cho, M.D., Principal investigator, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01277198
- Sponsor's protocol ID
- lapastone
- Other IDs
- flexible cysto in laparo
- Status last verified
- Jan 2011
- First submitted
- 13 Jan 2011
- Last updated
- 14 Jan 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of Flexible Cystoscopy in Laparoscopic Stone Surgery: a Single Surgeon Experience
- ClinicalTrials.gov ID
- NCT01277198
- Acronym / sponsor ID
- lapastone
- Conditions
- Kidney Calculi; Ureteral Calculi
- Keywords
- kidney calculi, ureteral calculi, cystoscopes, laparoscopes
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- Jan 2005
- Primary completion
- Aug 2010 (actual)
- Study completion
- Aug 2010 (actual)
- First posted
- 14 Jan 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- 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.
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (1 listed)
- active infection, uncontrolled bleeding tendency, previous abdominal surgery
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
1 secondary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jan 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sung Yong Cho, M.D. principal investigator
Seoul National University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Kidney Calculi; Ureteral Calculi, run by Seoul National University Hospital at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Jan 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the presence of residual stones (time frame: intravenous pyelogram at 12 weeks postoperatively). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jan 2011.