Urinary StonesFC-DMNCT03150446
The Usefulness of Flexible Cystoscopy for Preventing Double-J Stent Malposition After Laparoscopic Ureterolithotomy
A study testing flexible cystoscopy in people with Urinary Stones and Ureteral Calculus, run by Sung Gu Kang at 1 site in South Korea.
Trial summary
The aim of this study was to evaluate the role of flexible cystoscopy in preventing malpositioning of the ureteral stent after laparoscopic ureterolithotomy in male patients. From April 2009 to June 2015, 97 male patients with stones >1.8 cm in the upper ureter underwent intracorporeal double-J stenting of the ureter… Read more about this study
- Who is it for?
- Any age, men onlyHealthy volunteers can take part
- Conditions the study is for
- Urinary Stones, Ureteral Calculus
- What is being tested?
- flexible cystoscopy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteSouth Korea
- Study dates
- 1 Apr 2009to 30 Jun 2015
- Phase
- Interventional
- 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 Any age
- Men only
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- the patients with large stones (>1.8 cm in size) of the upper ureter
- male patients
Who cannot join
- the patients planing to be treated with other treatment except laparoscopic ureterolithotomy about the upper ureter stone
- female patients
- non operable patients
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Department of Urology, Korea University College of Medicine
Seoul, 136-701
About this study
The aim of this study was to evaluate the role of flexible cystoscopy in preventing malpositioning of the ureteral stent after laparoscopic ureterolithotomy in male patients.
From April 2009 to June 2015, 97 male patients with stones >1.8 cm in the upper ureter underwent intracorporeal double-J stenting of the ureter after laparoscopic ureterolithotomy performed by four different surgeons. In the last 50 patients who underwent laparoscopic ureterolithotomy flexible cystoscopy was performed through the urethral route to confirm the position of the double-J stent, while in the first 47 correct positioning of the stent was confirmed through postoperative KUB.
Read the detailed description
The treatment of large upper ureteral stones is still controversial. The American Urological Association (AUA) and the European Association of Urology (EAU) recommend that laparoscopic stone removal may be considered in rare cases in which shockwave lithotripsy (SWL), ureteroscopic lithotripsy (URS), and percutaneous nephrolithotomy fail or are unlikely to be successful. In a recent meta-analysis of treatment of large proximal ureteral stones, Torricelli et al. reported that the outcomes of laparoscopic ureterolithotomy (LUL) for larger upper ureteral stones are favorable compared with those of URS, and LUL should be considered as a first-line option when flexible ureteroscopy is not available. After such surgery, many surgeons prefer placing a double-J stent, a ureteral catheter that is passed through the ureter from the kidney to the bladder. Although double-J stent placement after LUL remains controversial, many urologists believe that it may help prevent postoperative urinary leakage.
Intracorporeal double-J stenting is technically difficult, and malpositioning often occurs after surgery in clinical practice. However, the actual rate of malpositioning of stents has not been reported yet. Although clinicians use different ways to place double-J stents precisely, accurate stent placement before the closure of the ureteral incision might be difficult to confirm.
Upward malpositioning of the stent after surgery may necessitate removal of the stent using a ureteroscope. It is difficult to remove stents in the outpatient setting without anesthesia to reduce pain and discomfort, especially in male patients.
In this study, The investigators used flexible cystoscopy through the urethral route before closure of the ureteral incision to confirm that the double-J stent was placed correctly in the bladder of male patients. Upon identification of upward malpositioning of the ureteral stent, position adjustments were performed by intracorporeally manipulating the ureteral stent through the incision site of the ureter. The aim of this study was to determine the malpositioning rate and predicting factors associated with upward malpositioning of intracorporeal double-J stents after LUL and to evaluate the usefulness of flexible cystoscopy in preventing such malpositioning in male patients.
- Conditions
- Urinary Stones, Ureteral Calculus
- Being tested
- flexible cystoscopy
- Keywords
- laparoscopy, ureteral catheterization
- Medical subject headings
- Urinary Calculi, Ureteral Calculi
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
flexible cystoscopyDevice
Also called Laparoscopic adjustment of double-J stent
After intracorporeal insertion of the double-J catheter, additional endoscopic monitoring with flexible cystoscopy was performed. The surgeon manipulating the double-J catheter used monitor A, while an assistant inserted a flexible cystoscope into the bladder through the urethral route and determined whether the double-J stent was correctly placed in the bladder using monitor B before suturing the site of ureterotomy. If the stent was well-placed, the flexible cystoscope was withdrawn. If the double-J stent was not visualized in the bladder, the surgeon pushed the stent inferiorly using a laparoscopic instrument and monitor A until the stent came out through the ureteral orifice on monitor B.
| Study group | Role | What they receive |
|---|---|---|
| The group using flexible cystoscopy | Experimental | 50 patients with large upper ureteral stones underwent laparoscopic ureterolithotomy with flexible cystoscopy to confirm the correct positioning of the double-J stent. After intracorporeal insertion of the double-J catheter, additional endoscopic monitoring with flexible cystoscopy was performed. The surgeon manipulating the double-J catheter used monitor A, while an assistant inserted a flexible cystoscope into the bladder through the urethral route and determined whether the double-J stent was correctly placed in the bladder using monitor B before suturing the site of ureterotomy. Receives: Device: flexible cystoscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
upward malpositioning of ureteral stents
whether the double-J stent was correctly placed in the bladder
Measured: 5 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2017
- Study start1 Apr 2009
- Primary completion30 Jun 2015
- Study completion30 Jun 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Urinary StonesStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- From April 2009 to June 2015, 97 male patients with stones \>1.8 cm in the upper ureter underwent intracorporeal double-J stenting of the ureter after laparoscopic ureterolithotomy performed by four different surgeons. The 50 participants was performed with flexible cystoscopy through the urethral route to confirm the position of the double-J stent.
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sung Gu Kang
- Sponsor type
- University, hospital or other
- Collaborators
- Korea University Anam Hospital
- Responsible party
- Sponsor-investigator, Sung Gu Kang, Korea University Anam Hospital
- Investigators
- Sung Gu Kang, Professor, Study director, Department of Urology, Korea University College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03150446
- Sponsor's protocol ID
- FC-DM 1.0
- Acronym
- FC-DM
- Status last verified
- May 2017
- First submitted
- 5 May 2017
- Last updated
- 12 May 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Kim JY, Kang SH, Cheon J, Lee JG, Kim JJ, Kang SG. The usefulness of flexible cystoscopy for preventing double-J stent malposition after laparoscopic ureterolithotomy. BMC Urol. 2017 Jun 15;17(1):44. doi: 10.1186/s12894-017-0232-4.
PubMed 28619091
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Usefulness of Flexible Cystoscopy for Preventing Double-J Stent Malposition After Laparoscopic Ureterolithotomy
- ClinicalTrials.gov ID
- NCT03150446
- Acronym / sponsor ID
- FC-DM / FC-DM 1.0
- Conditions
- Urinary Stones, Ureteral Calculus
- Keywords
- laparoscopy, ureteral catheterization
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Sung Gu KangUniversity, hospital or other
- Collaborators
- Korea University Anam Hospital
- Study start
- 1 Apr 2009 (actual)
- Primary completion
- 30 Jun 2015 (actual)
- Study completion
- 30 Jun 2015 (actual)
- First posted
- 12 May 2017 (actual)
- 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.
The aim of this study was to evaluate the role of flexible cystoscopy in preventing malpositioning of the ureteral stent after laparoscopic ureterolithotomy in male patients.
From April 2009 to June 2015, 97 male patients with stones >1.8 cm in the upper ureter underwent intracorporeal double-J stenting of the ureter after laparoscopic ureterolithotomy performed by four different surgeons. In the last 50 patients who underwent laparoscopic ureterolithotomy flexible cystoscopy was performed through the urethral route to confirm the position of the double-J stent, while in the first 47 correct positioning of the stent was confirmed through postoperative KUB.
Detailed description
The treatment of large upper ureteral stones is still controversial. The American Urological Association (AUA) and the European Association of Urology (EAU) recommend that laparoscopic stone removal may be considered in rare cases in which shockwave lithotripsy (SWL), ureteroscopic lithotripsy (URS), and percutaneous nephrolithotomy fail or are unlikely to be successful. In a recent meta-analysis of treatment of large proximal ureteral stones, Torricelli et al. reported that the outcomes of laparoscopic ureterolithotomy (LUL) for larger upper ureteral stones are favorable compared with those of URS, and LUL should be considered as a first-line option when flexible ureteroscopy is not available. After such surgery, many surgeons prefer placing a double-J stent, a ureteral catheter that is passed through the ureter from the kidney to the bladder. Although double-J stent placement after LUL remains controversial, many urologists believe that it may help prevent postoperative urinary leakage.
Intracorporeal double-J stenting is technically difficult, and malpositioning often occurs after surgery in clinical practice. However, the actual rate of malpositioning of stents has not been reported yet. Although clinicians use different ways to place double-J stents precisely, accurate stent placement before the closure of the ureteral incision might be difficult to confirm.
Upward malpositioning of the stent after surgery may necessitate removal of the stent using a ureteroscope. It is difficult to remove stents in the outpatient setting without anesthesia to reduce pain and discomfort, especially in male patients.
In this study, The investigators used flexible cystoscopy through the urethral route before closure of the ureteral incision to confirm that the double-J stent was placed correctly in the bladder of male patients. Upon identification of upward malpositioning of the ureteral stent, position adjustments were performed by intracorporeally manipulating the ureteral stent through the incision site of the ureter. The aim of this study was to determine the malpositioning rate and predicting factors associated with upward malpositioning of intracorporeal double-J stents after LUL and to evaluate the usefulness of flexible cystoscopy in preventing such malpositioning in male patients.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- From April 2009 to June 2015, 97 male patients with stones >1.8 cm in the upper ureter underwent intracorporeal double-J stenting of the ureter after laparoscopic ureterolithotomy performed by four different surgeons. The 50 participants was performed with flexible cystoscopy through the urethral route to confirm the position of the double-J stent.
| Arm | Type | Receives |
|---|---|---|
| The group using flexible cystoscopy | Experimental | Device: flexible cystoscopy50 patients with large upper ureteral stones underwent laparoscopic ureterolithotomy with flexible cystoscopy to confirm the correct positioning of the double-J stent. After intracorporeal insertion of the double-J catheter, additional endoscopic monitoring with flexible cystoscopy was performed. The surgeon manipulating the double-J catheter used monitor A, while an assistant inserted a flexible cystoscope into the bladder through the urethral route and determined whether the double-J stent was correctly placed in the bladder using monitor B before suturing the site of ureterotomy. |
Who may qualify
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- the patients with large stones (>1.8 cm in size) of the upper ureter
- male patients
Key exclusion criteria (3 listed)
- the patients planing to be treated with other treatment except laparoscopic ureterolithotomy about the upper ureter stone
- female patients
- non operable patients
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| flexible cystoscopyAlso: Laparoscopic adjustment of double-J stentAfter intracorporeal insertion of the double-J catheter, additional endoscopic monitoring with flexible cystoscopy was performed. The surgeon manipulating the double-J catheter used monitor A, while an assistant inserted a flexible cystoscope into the bladder through the urethral route and determined whether the double-J stent was correctly placed in the bladder using monitor B before suturing the site of ureterotomy. If the stent was well-placed, the flexible cystoscope was withdrawn. If the double-J stent was not visualized in the bladder, the surgeon pushed the stent inferiorly using a laparoscopic instrument and monitor A until the stent came out through the ureteral orifice on monitor B. | Device | The group using flexible cystoscopy |
Primary outcome
upward malpositioning of ureteral stents
Time frame: 5 minutes
whether the double-J stent was correctly placed in the bladder
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 12 May 2017.
- Derived from this study: PubMed 28619091Kim JY, Kang SH, Cheon J, Lee JG, Kim JJ, Kang SG. The usefulness of flexible cystoscopy for preventing double-J stent malposition after laparoscopic ureterolithotomy. BMC Urol. 2017 Jun 15;17(1):44. doi: 10.1186/s12894-017-0232-4.
- Individual participant dataSharing planned: No
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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 Gu Kang, Professor study director
Department of Urology, Korea University College of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing flexible cystoscopy in people with Urinary Stones and Ureteral Calculus, run by Sung Gu Kang 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 3 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 12 May 2017. 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?
upward malpositioning of ureteral stents (time frame: 5 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03150446, which also lists 1 linked publication.
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 12 May 2017.