Surgery--ComplicationsNCT03307096
Evaluation of Two Different Treatments for Lower Pore Renal Stone: Microperc Vs FURS
A study testing Microperc surgery and FURS in people with Surgery--Complications and Renal Calculus, run by Ningbo No. 1 Hospital at 1 site in China.
Trial summary
This is a prospect, randomized control trial to evaluate merits between microperc and FURS for lower pole renal stone Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Surgery--Complications, Renal Calculus, Nephrolithiasis
- What is being tested?
- Microperc surgery and FURS
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteChina
- Study dates
- 17 Nov 2017to 31 Dec 2019
- 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 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 10-20mm lower pole renal stone measured by KUB or CT;
- Age between 18-60 years, no gender limitation;
- Participators can understand the research and sign the consent form without mental illness nor language disorder;
- Low pole renal stone left after lithotripsy;
- Lower pole infundibulopelvic angle which measured by IVP or CTU will less than 30 degree;
- Asymptomatic patients with positive urine white blood cells and negative preoperative urine culture should be treated with antibiotics for 3days before operation;
- Patients with symptoms of urinary infections, positive urine withe blood cells and positive preoperative urine culture should be treated with suitable antibiotics based on the culture sensitivity result for at least 7days before operation.
Who cannot join
- Transplant kidney stone;
- Renal malformations, such as UPJO, medullary sponge kidney, polycystic kidney, horseshoe kidney, etc.;
- Combine other part of urinary stones need to be handle at the same procedure, for example ureteral stone, renal pelvic stone, middle or upper pole renal stone;
- Hematological Disease or Coagulation disorders;
- Withdraw anticoagulant medicine less than two weeks;
- Fever or urinary infections without treatment according to the inclusion criteria;
Show all 10Show fewer
- Sevier renal dysfunction(endogenous creatinine clearance rate≤50ml/min)
- Middle or severe hydronephrosis(dilatation of the renal pelvis ≥20mm by ultrasound);
- Women in menstrual period or pregnancy;
- Patients have severe disease, such as heart disease, lung dysfunction, and multiple organ failure that cannot tolerate anesthesia or operation.
Trial locations and contacts
1 site in 1 country.
About this study
This is a prospect, randomized control trial to evaluate merits between microperc and FURS for lower pole renal stone
Read the detailed description
To evaluate the merits of Microperc and RIRS for the treatment for lower pole renal stone between 10-20 mm. Investigators will do a multi-centers randomized controlled trial(RCT). A total of 200 (three hundred) patients, aging between 18 and 60 years are being planned to be enrolled into the study; By simple random sampling technique, patients will be prospectively randomized into group A and group B with a 1:1 ratio. Group A will receive the microperc surgery and group B will undergo FURS.
All the patients will be diagnosed definitely before operations with non-contrast CT+IVP or CTU, lower pole Infundibular length, Infundibular width and Lower pole infundibulopelvic angle were recorded. A double J stent will be inserted in two the relevant ureter two weeks before surgery to guarantee the successful of operations. Patience will receive either microperic or FURS respectively, The operation time , hemoglobin change, renal function, post-operation pain, complications and hospital stay will be recorded. Patience will have follow-up visits at one month and three months, CT and KUB will be taken to evaluate the clearance of renal stone.
Surgical technique Microperc surgery: After the satisfaction of anesthesia, Patient is turned into prone position and the desired calyx is punctured by 4.8F microperc under fluoroscopic or sonographic guidance. No tract dilation is needed. A 200um holmium laser fiber will be used to break stone into less than 2mm. Pull out microperc without drainage tube left; RIRS: After the satisfaction of anesthesia, the patient is placed in the lithotomy position, pull out the pre-inserted double J stent, and place guidewire into the renal pelvis. A 12/14 Fr ureteral access sheath (UAS) is advanced into the proximal ureter over the guidewire, and flexible ureteroscope is passed through the UAS. The stones are fragmented smeller than 2mm using a 200um holmium laser fiber. Fragments are removed using a stone basket for stone analysis if necessary, a double J stent is placed at the conclusion of the procedure and removed post-operative 2 weeks.
Data collection Data for the 2 groups-demographic characteristics, hemoglobin(HB) decrease, white blood cell(WBC) increase, postoperative pain, duration of postoperative hospital stay, complications (modified Clavien system), stone clearance (SFR) and the need for auxiliary treatment are compared.
Mean study endpoint: Final SFR (3 months after procedure) Secondary endpoint: Complications, duration of postoperative hospital stay. re-microperc, ureteroscopy and SWL are considered as auxiliary treatments.
The stone size is defined as the maximum diameter as determined by CT scans. Degree of hydronephrosis are assigned as follow: none (no calyx or pelvic dilation), mild (pelvic dilatation alone), moderate (mild calyx dilation), or severe (severe calyx dilation or calyx dilation accompanied by renal parenchyma atrophy).
Definition of operation time:
For microperc: recorded from the time of the first percutaneous renal puncture to pulling out the microperc.
For RIRS: recorded from insertion of an endoscope into the urethra to the completion of stent placement.
Hospital stay are rounded to the nearest whole day and calculated from the day of surgery to the day of discharge.
Postoperative pain (visual analogue scale(VAS), use of analgesics) will be recorded.
The rate of hemoglobin decrease is assessed by comparing the preoperative Hb level with 24-hour postoperative Hb level.
Non-contrast CT and KUB is obtained for all patients at 3 month after the operation to evaluate the final SFR, allowing time for the spontaneous passage of stone fragments.
Stone-free status are defined as either the absence of any residual stone fragments or the presence of clinically insignificant residual stone fragments in the kidney which were defined as ≤4mm, asymptomatic, non-obstructive and non-infectious stone particles.
Complications of all patients are recorded according to modified Clavien classification system.
- Conditions
- Surgery--Complications, Renal Calculus, Nephrolithiasis, Urolithiasis
- Being tested
- Microperc surgery, FURS
- Keywords
- FURS, microperc, renal calculus, Randomized Controlled Trial, Retrograde Intrarenal Surgery
- Medical subject headings
- Kidney Calculi, Nephrolithiasis, Urolithiasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Microperc surgeryProcedure or surgery
Parents are treated by Microperc Percutaneous Nephrolithotomy
FURSProcedure or surgery
Parents are treated by FURS
| Study group | Role | What they receive |
|---|---|---|
| Microperc surgery | Experimental | Patient is turned into prone position and the desired calyx is punctured by 4.8F microperc under fluoroscopic or sonographic guidance. No tract dilation is needed. A 200um holmium laser fiber will be used to break stone into less than 2mm. Pull out microperc without drainage tube left. Receives: Procedure: Microperc surgery |
| FURS | Active comparator | Patient is placed in the lithotomy position, pull out the pre-inserted double J, and place guidewire into the renal pelvis. A 12/14 Fr ureteral access sheath (UAS) is advanced into the proximal ureter over the guidewire, and flexible ureteroscope is passed through the UAS. The stones are fragmented smeller than 2mm using a 200um holmium laser fiber. Fragments are removed using a stone basket for stone analysis if necessary, a double J stent is placed at the conclusion of the procedure and removed post-operative 4 weeks. Receives: Procedure: FURS |
What is being measured
The primary outcome is the main question the study is designed to answer.
SFR
Stone free Rate
Measured: 3 month
Secondary outcomes (5)
Complications
Complications after surgery
Measured: 3 month
Duration of postoperative hospital stay
Duration of postoperative hospital stay
Measured: 7 days
Postoperative pain
Postoperative pain,visual analogue scale(VAS)
Measured: 3 month
The rate of hemoglobin decrease
The rate of hemoglobin decrease
Measured: 7 days
Operation time
Operation time of surgery
Measured: 12 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Oct 2017
- Study start17 Nov 2017 (estimated)
- Primary completion1 Oct 2019 (estimated)
- Study completion31 Dec 2019 (estimated)
Why it stopped: The project has come to an end due to a lack of necessary funding support.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (13)Papers the sponsor has linked to this study.
- Other trials for Surgery--ComplicationsStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- A total of 200 patients, aging between 18 and 60 years are enrolled into the study, patients will be prospectively randomized into group A and group B with a 1:1 ratio. Group A will receive the microperc surgery and group B will undergo FURS.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ningbo No. 1 Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Beijing Friendship Hospital, Renmin Hospital of Wuhan University, Affiliated Hospital of Hebei University, Jiangsu Province Hospital of Traditional Chinese Medicine, West China Hospital, Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University, People's Hospital of Anshun City of Guizhou Province, Zhejiang Provincial People's Hospital, The First Affiliated Hospital with Nanjing Medical University, First Affiliated Hospital of Xinjiang Medical University, General Hospital of Shenyang Military Region
- Responsible party
- Principal investigator, Li Fang, Ningbo No. 1 Hospital
- Investigators
- Yue Cheng, Dr., Principal investigator, Ningbo No. 1 Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03307096
- Sponsor's protocol ID
- NBDYYY2017003
- Status last verified
- Jul 2024
- First submitted
- 30 Sep 2017
- Last updated
- 9 Jul 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Sener NC, Imamoglu MA, Bas O, Ozturk U, Goktug HN, Tuygun C, Bakirtas H. Prospective randomized trial comparing shock wave lithotripsy and flexible ureterorenoscopy for lower pole stones smaller than 1 cm. Urolithiasis. 2014 Apr;42(2):127-31. doi: 10.1007/s00240-013-0618-z. Epub 2013 Nov 13.
PubMed 24220692Ozgur Tan M, Irkilata L, Sen I, Onaran M, Kupeli B, Karaoglan U, Bozkirli I. The impact of radiological anatomy in clearance of lower caliceal stones after shock wave lithotripsy. Urol Res. 2007 Jun;35(3):143-7. doi: 10.1007/s00240-007-0093-5. Epub 2007 Apr 20.
PubMed 17447057Juan YS, Chuang SM, Wu WJ, Shen JT, Wang CJ, Huang CH. Impact of lower pole anatomy on stone clearance after shock wave lithotripsy. Kaohsiung J Med Sci. 2005 Aug;21(8):358-64. doi: 10.1016/S1607-551X(09)70134-2.
PubMed 16158878Turk C. [Urolithiasis guidelines: retrospective view and perspectives]. Urologe A. 2016 Oct;55(10):1317-1320. doi: 10.1007/s00120-016-0230-2. German.
PubMed 27604704Molina WR, Kim FJ, Spendlove J, Pompeo AS, Sillau S, Sehrt DE. The S.T.O.N.E. Score: a new assessment tool to predict stone free rates in ureteroscopy from pre-operative radiological features. Int Braz J Urol. 2014 Jan-Feb;40(1):23-9. doi: 10.1590/S1677-5538.IBJU.2014.01.04.
PubMed 24642147Elbahnasy AM, Clayman RV, Shalhav AL, Hoenig DM, Chandhoke P, Lingeman JE, Denstedt JD, Kahn R, Assimos DG, Nakada SY. Lower-pole caliceal stone clearance after shockwave lithotripsy, percutaneous nephrolithotomy, and flexible ureteroscopy: impact of radiographic spatial anatomy. J Endourol. 1998 Apr;12(2):113-9. doi: 10.1089/end.1998.12.113.
PubMed 9607435Resorlu B, Unsal A, Gulec H, Oztuna D. A new scoring system for predicting stone-free rate after retrograde intrarenal surgery: the "resorlu-unsal stone score". Urology. 2012 Sep;80(3):512-8. doi: 10.1016/j.urology.2012.02.072. Epub 2012 Jul 26.
PubMed 22840867Kilicarslan H, Kaynak Y, Kordan Y, Kaygisiz O, Coskun B, Gunseren KO, Kanat FM. Unfavorable anatomical factors influencing the success of retrograde intrarenal surgery for lower pole renal calculi. Urol J. 2015 Apr 29;12(2):2065-8.
PubMed 25923149Resorlu B, Oguz U, Resorlu EB, Oztuna D, Unsal A. The impact of pelvicaliceal anatomy on the success of retrograde intrarenal surgery in patients with lower pole renal stones. Urology. 2012 Jan;79(1):61-6. doi: 10.1016/j.urology.2011.06.031.
PubMed 21855968Inoue T, Murota T, Okada S, Hamamoto S, Muguruma K, Kinoshita H, Matsuda T; SMART Study Group. Influence of Pelvicaliceal Anatomy on Stone Clearance After Flexible Ureteroscopy and Holmium Laser Lithotripsy for Large Renal Stones. J Endourol. 2015 Sep;29(9):998-1005. doi: 10.1089/end.2015.0071. Epub 2015 May 15.
PubMed 25879676Sabnis RB, Ganesamoni R, Doshi A, Ganpule AP, Jagtap J, Desai MR. Micropercutaneous nephrolithotomy (microperc) vs retrograde intrarenal surgery for the management of small renal calculi: a randomized controlled trial. BJU Int. 2013 Aug;112(3):355-61. doi: 10.1111/bju.12164.
PubMed 23826843Karatag T, Tepeler A, Silay MS, Bodakci MN, Buldu I, Daggulli M, Hatipoglu NK, Istanbulluoglu MO, Armagan A. A Comparison of 2 Percutaneous Nephrolithotomy Techniques for the Treatment of Pediatric Kidney Stones of Sizes 10-20 mm: Microperc vs Miniperc. Urology. 2015 May;85(5):1015-1018. doi: 10.1016/j.urology.2015.02.010.
PubMed 25917724Soderberg L, Ergun O, Ding M, Parker R, Borofsky MS, Pais V, Dahm P. Percutaneous nephrolithotomy versus retrograde intrarenal surgery for treatment of renal stones in adults. Cochrane Database Syst Rev. 2023 Nov 13;11(11):CD013445. doi: 10.1002/14651858.CD013445.pub2.
PubMed 37955353
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Two Different Treatments for Lower Pore Renal Stone: Microperc Vs FURS
- ClinicalTrials.gov ID
- NCT03307096
- Acronym / sponsor ID
- NBDYYY2017003
- Conditions
- Surgery--Complications, Renal Calculus, Nephrolithiasis, Urolithiasis
- Keywords
- FURS, microperc, renal calculus, Randomized Controlled Trial, Retrograde Intrarenal Surgery
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: The project has come to an end due to a lack of necessary funding support.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Ningbo No. 1 HospitalUniversity, hospital or other
- Collaborators
- Beijing Friendship Hospital, Renmin Hospital of Wuhan University, Affiliated Hospital of Hebei University, Jiangsu Province Hospital of Traditional Chinese Medicine, West China Hospital, Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University, People's Hospital of Anshun City of Guizhou Province, Zhejiang Provincial People's Hospital, The First Affiliated Hospital with Nanjing Medical University, First Affiliated Hospital of Xinjiang Medical University, General Hospital of Shenyang Military Region
- Study start
- 17 Nov 2017 (estimated)
- Primary completion
- 1 Oct 2019 (estimated)
- Study completion
- 31 Dec 2019 (estimated)
- First posted
- 11 Oct 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.
This is a prospect, randomized control trial to evaluate merits between microperc and FURS for lower pole renal stone
Detailed description
To evaluate the merits of Microperc and RIRS for the treatment for lower pole renal stone between 10-20 mm. Investigators will do a multi-centers randomized controlled trial(RCT). A total of 200 (three hundred) patients, aging between 18 and 60 years are being planned to be enrolled into the study; By simple random sampling technique, patients will be prospectively randomized into group A and group B with a 1:1 ratio. Group A will receive the microperc surgery and group B will undergo FURS.
All the patients will be diagnosed definitely before operations with non-contrast CT+IVP or CTU, lower pole Infundibular length, Infundibular width and Lower pole infundibulopelvic angle were recorded. A double J stent will be inserted in two the relevant ureter two weeks before surgery to guarantee the successful of operations. Patience will receive either microperic or FURS respectively, The operation time , hemoglobin change, renal function, post-operation pain, complications and hospital stay will be recorded. Patience will have follow-up visits at one month and three months, CT and KUB will be taken to evaluate the clearance of renal stone.
Surgical technique Microperc surgery: After the satisfaction of anesthesia, Patient is turned into prone position and the desired calyx is punctured by 4.8F microperc under fluoroscopic or sonographic guidance. No tract dilation is needed. A 200um holmium laser fiber will be used to break stone into less than 2mm. Pull out microperc without drainage tube left; RIRS: After the satisfaction of anesthesia, the patient is placed in the lithotomy position, pull out the pre-inserted double J stent, and place guidewire into the renal pelvis. A 12/14 Fr ureteral access sheath (UAS) is advanced into the proximal ureter over the guidewire, and flexible ureteroscope is passed through the UAS. The stones are fragmented smeller than 2mm using a 200um holmium laser fiber. Fragments are removed using a stone basket for stone analysis if necessary, a double J stent is placed at the conclusion of the procedure and removed post-operative 2 weeks.
Data collection Data for the 2 groups-demographic characteristics, hemoglobin(HB) decrease, white blood cell(WBC) increase, postoperative pain, duration of postoperative hospital stay, complications (modified Clavien system), stone clearance (SFR) and the need for auxiliary treatment are compared.
Mean study endpoint: Final SFR (3 months after procedure) Secondary endpoint: Complications, duration of postoperative hospital stay. re-microperc, ureteroscopy and SWL are considered as auxiliary treatments.
The stone size is defined as the maximum diameter as determined by CT scans. Degree of hydronephrosis are assigned as follow: none (no calyx or pelvic dilation), mild (pelvic dilatation alone), moderate (mild calyx dilation), or severe (severe calyx dilation or calyx dilation accompanied by renal parenchyma atrophy).
Definition of operation time:
For microperc: recorded from the time of the first percutaneous renal puncture to pulling out the microperc.
For RIRS: recorded from insertion of an endoscope into the urethra to the completion of stent placement.
Hospital stay are rounded to the nearest whole day and calculated from the day of surgery to the day of discharge.
Postoperative pain (visual analogue scale(VAS), use of analgesics) will be recorded.
The rate of hemoglobin decrease is assessed by comparing the preoperative Hb level with 24-hour postoperative Hb level.
Non-contrast CT and KUB is obtained for all patients at 3 month after the operation to evaluate the final SFR, allowing time for the spontaneous passage of stone fragments.
Stone-free status are defined as either the absence of any residual stone fragments or the presence of clinically insignificant residual stone fragments in the kidney which were defined as ≤4mm, asymptomatic, non-obstructive and non-infectious stone particles.
Complications of all patients are recorded according to modified Clavien classification system.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- A total of 200 patients, aging between 18 and 60 years are enrolled into the study, patients will be prospectively randomized into group A and group B with a 1:1 ratio. Group A will receive the microperc surgery and group B will undergo FURS.
| Arm | Type | Receives |
|---|---|---|
| Microperc surgery | Experimental | Procedure: Microperc surgeryPatient is turned into prone position and the desired calyx is punctured by 4.8F microperc under fluoroscopic or sonographic guidance. No tract dilation is needed. A 200um holmium laser fiber will be used to break stone into less than 2mm. Pull out microperc without drainage tube left. |
| FURS | Active comparator | Procedure: FURSPatient is placed in the lithotomy position, pull out the pre-inserted double J, and place guidewire into the renal pelvis. A 12/14 Fr ureteral access sheath (UAS) is advanced into the proximal ureter over the guidewire, and flexible ureteroscope is passed through the UAS. The stones are fragmented smeller than 2mm using a 200um holmium laser fiber. Fragments are removed using a stone basket for stone analysis if necessary, a double J stent is placed at the conclusion of the procedure and removed post-operative 4 weeks. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 10-20mm lower pole renal stone measured by KUB or CT;
- Age between 18-60 years, no gender limitation;
- Participators can understand the research and sign the consent form without mental illness nor language disorder;
- Low pole renal stone left after lithotripsy;
- Lower pole infundibulopelvic angle which measured by IVP or CTU will less than 30 degree;
Key exclusion criteria (10 listed)
- Transplant kidney stone;
- Renal malformations, such as UPJO, medullary sponge kidney, polycystic kidney, horseshoe kidney, etc.;
- Combine other part of urinary stones need to be handle at the same procedure, for example ureteral stone, renal pelvic stone, middle or upper pole renal stone;
- Hematological Disease or Coagulation disorders;
- Withdraw anticoagulant medicine less than two weeks;
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 |
|---|---|---|
| Microperc surgeryParents are treated by Microperc Percutaneous Nephrolithotomy | Procedure or surgery | Microperc surgery |
| FURSParents are treated by FURS | Procedure or surgery | FURS |
Primary outcome
SFR
Time frame: 3 month
Stone free Rate
5 secondary outcomes
Complications
Time frame: 3 month
Duration of postoperative hospital stay
Time frame: 7 days
Postoperative pain
Time frame: 3 month
The rate of hemoglobin decrease
Time frame: 7 days
Operation time
Time frame: 12 hours
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jul 2024.
- Background: PubMed 24220692Sener NC, Imamoglu MA, Bas O, Ozturk U, Goktug HN, Tuygun C, Bakirtas H. Prospective randomized trial comparing shock wave lithotripsy and flexible ureterorenoscopy for lower pole stones smaller than 1 cm. Urolithiasis. 2014 Apr;42(2):127-31. doi: 10.1007/s00240-013-0618-z. Epub 2013 Nov 13.
- Background: PubMed 17447057Ozgur Tan M, Irkilata L, Sen I, Onaran M, Kupeli B, Karaoglan U, Bozkirli I. The impact of radiological anatomy in clearance of lower caliceal stones after shock wave lithotripsy. Urol Res. 2007 Jun;35(3):143-7. doi: 10.1007/s00240-007-0093-5. Epub 2007 Apr 20.
- Background: PubMed 16158878Juan YS, Chuang SM, Wu WJ, Shen JT, Wang CJ, Huang CH. Impact of lower pole anatomy on stone clearance after shock wave lithotripsy. Kaohsiung J Med Sci. 2005 Aug;21(8):358-64. doi: 10.1016/S1607-551X(09)70134-2.
- Background: PubMed 27604704Turk C. [Urolithiasis guidelines: retrospective view and perspectives]. Urologe A. 2016 Oct;55(10):1317-1320. doi: 10.1007/s00120-016-0230-2. German.
- Background: PubMed 24642147Molina WR, Kim FJ, Spendlove J, Pompeo AS, Sillau S, Sehrt DE. The S.T.O.N.E. Score: a new assessment tool to predict stone free rates in ureteroscopy from pre-operative radiological features. Int Braz J Urol. 2014 Jan-Feb;40(1):23-9. doi: 10.1590/S1677-5538.IBJU.2014.01.04.
- Background: PubMed 9607435Elbahnasy AM, Clayman RV, Shalhav AL, Hoenig DM, Chandhoke P, Lingeman JE, Denstedt JD, Kahn R, Assimos DG, Nakada SY. Lower-pole caliceal stone clearance after shockwave lithotripsy, percutaneous nephrolithotomy, and flexible ureteroscopy: impact of radiographic spatial anatomy. J Endourol. 1998 Apr;12(2):113-9. doi: 10.1089/end.1998.12.113.
- Results publication: PubMed 22840867Resorlu B, Unsal A, Gulec H, Oztuna D. A new scoring system for predicting stone-free rate after retrograde intrarenal surgery: the "resorlu-unsal stone score". Urology. 2012 Sep;80(3):512-8. doi: 10.1016/j.urology.2012.02.072. Epub 2012 Jul 26.
- Results publication: PubMed 25923149Kilicarslan H, Kaynak Y, Kordan Y, Kaygisiz O, Coskun B, Gunseren KO, Kanat FM. Unfavorable anatomical factors influencing the success of retrograde intrarenal surgery for lower pole renal calculi. Urol J. 2015 Apr 29;12(2):2065-8.
- Results publication: PubMed 21855968Resorlu B, Oguz U, Resorlu EB, Oztuna D, Unsal A. The impact of pelvicaliceal anatomy on the success of retrograde intrarenal surgery in patients with lower pole renal stones. Urology. 2012 Jan;79(1):61-6. doi: 10.1016/j.urology.2011.06.031.
- Results publication: PubMed 25879676Inoue T, Murota T, Okada S, Hamamoto S, Muguruma K, Kinoshita H, Matsuda T; SMART Study Group. Influence of Pelvicaliceal Anatomy on Stone Clearance After Flexible Ureteroscopy and Holmium Laser Lithotripsy for Large Renal Stones. J Endourol. 2015 Sep;29(9):998-1005. doi: 10.1089/end.2015.0071. Epub 2015 May 15.
- Results publication: PubMed 23826843Sabnis RB, Ganesamoni R, Doshi A, Ganpule AP, Jagtap J, Desai MR. Micropercutaneous nephrolithotomy (microperc) vs retrograde intrarenal surgery for the management of small renal calculi: a randomized controlled trial. BJU Int. 2013 Aug;112(3):355-61. doi: 10.1111/bju.12164.
- Results publication: PubMed 25917724Karatag T, Tepeler A, Silay MS, Bodakci MN, Buldu I, Daggulli M, Hatipoglu NK, Istanbulluoglu MO, Armagan A. A Comparison of 2 Percutaneous Nephrolithotomy Techniques for the Treatment of Pediatric Kidney Stones of Sizes 10-20 mm: Microperc vs Miniperc. Urology. 2015 May;85(5):1015-1018. doi: 10.1016/j.urology.2015.02.010.
- Individual participant dataSharing planned: Undecided
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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.
Yue Cheng, Dr. principal investigator
Ningbo No. 1 Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Microperc surgery and FURS in people with Surgery--Complications and Renal Calculus, run by Ningbo No. 1 Hospital at 1 site in China.
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 7 inclusion and 10 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: withdrawn, as of the sponsor's last update on 9 Jul 2024. 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 China. 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 was withdrawn before enrolling participants, so there are no results.
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?
SFR (time frame: 3 month). 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 NCT03307096, which also lists 13 linked publications.
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 9 Jul 2024.