Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
NA
100 participants
INTERVENTIONAL
2016-04-30
2018-03-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
The present system of Super-Mini percutaneous nephrolithotomy (SMP) was developed to address many of these deficiencies. The basic components of SMP system are an 8.0 F miniaturized nephroscope with a newly designed irrigation-suction sheath with enhanced irrigation capability and modified nephrostomy sheath with continuous negative pressure aspiration. Its design was intended not only to prevent the excessive intrarenal pressure but also improve the visualization and the stone fragments extraction.
Little was known about renal pelvic pressure in vivo during SMP and about any correlation it might have had with postoperative fever and urosepsis. We measure the renal pelvic pressure during SMP to determine whether it will improve the renal pelvic pressure and improve the incidence of postoperative fever.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
PCNL Without Reverse Catheterization in the Split-leg Prone Position.
NCT06750913
Comparison of the Efficacy of Flexible Ureteroscope and Percutaneous Nephroscopic Surgery in the Treatment of 2-4cm Kidney Stones
NCT06507176
Mini-PCNL Versus Standard-PCNL For The Management of 20-40 mm Size Kidney Stones
NCT02635048
SMP vs RIRS for Symptomatic Lower Pole Renal Calculi of 10-20 mm Size: a Randomized Controlled Trial
NCT02519634
Tubeless Percutaneous Nephrolithotomy Without Reverse Insertion of a Ureteral Catheter
NCT05574517
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Investigators plan to beginning their study at April in 2016 and end at March in 2018.One hundred patients with renal calculi measuring smaller than 25 mm will be enrolled in this study. By simple random sampling technique, patients will be assigned to two 50-patient groups(group 1:F14,group2 :F12).All the patients will be diagnosed definitely before operations with non-contrast CT. Patients with positive preoperative urine culture should be treated with suitable antibiotics based on the culture sensitivity result for at least 72h before SMP. Patients who have negative urine culture should receive a single dose of broad spectrum antibiotic prophylaxis just prior to the procedure.
Surgical technique Routine preoperative preparations are carried out as for conventional percutaneous surgery. Under general anesthesia and with the patient in the lithotomy position, an open-ended 5F ureteral catheter is advanced into the renal pelvis under direct vision. The patient is then turned into the prone position. Percutaneous access is achieved using an 18-gauge coaxial needle to puncture the selected calyx under fluoroscopic or ultrasonic guidance. The success of the puncture is confirmed both by the free flow of the irrigation fluid and by fluoroscopic images. Using a guidewire, the dilatation is carried out with 10 F fascial dilators. Thenan irrigation-suction straight sheath, with the obturator, is advanced over the guidewire and introduced into the pelvicalyceal system. The guidewireis then removed, and the "handle" is connected to the straight sheath. The irrigation port of the irrigation-suction sheath is connected to an irrigation pump. The oblique tube of the sheath is connected to the specimen collection bottle, and the bottle then to the negative pressure aspirator. The irrigation fluid pressure is set as 200-250 mmHg. The suction pressure is controlled to a setting of 100-150 mmHg. The irrigation is delivered through the irrigation channel of the sheath. Thus, a one-way flow is created as the inflow that comes out of the irrigation channel of the sheath is immediately aspirated through the suction conduitof the sheath. Stone fragmentation is accomplished using either holmium laser or pneumatic lithotripter. The tiny pulverized stone fragments will pass around the scope and evacuate through the oblique sluice. If the stone fragments are too large to pass around the scope inside the sheath, the scope can be withdrawn slowly to proximal to the bifurcation in order to create an unobstructed channel for larger fragments evacuation. At the end of the procedure, a single fluoroscopic image is obtained to assess the stone-free status. A Double-J stent is placed only when there is the presence of an obstructing inflammatory ureteric edema, ureteropelvic junction obstruction, or concurrent treatment of ipsilateral ureteric stone with rigid ureteroscope. The sheath is removed, and the wound is either sutured or seal with absorbable gelatin. For patients with significant bleeding or extravasation, a nephrostomy tube is placed.
Measurement of Renal Pelvic Pressure In Vivo While preparing for the SMP, the open-ended ureteric catheter, which had been inserted into the renal collecting system retrogradely, was connected to the invasive blood pressure channel of patient monitor with a baroceptor. The baroceptor was fixed onto the horizontal plane of renal pelvis; after a zero adjustment, the measurement of renal pelvic pressure was in session. A computer collected the renal pelvic pressure data each second. Any factor that caused a high renal pelvic pressure was noticed .
Data collection Data for the 2 groups -demographic characteristics, site of access ,Hb decrease, CRP increase, WBC increase, postoperative pain, operation time, hospital stay, cases of tubeless, postoperative infection complications (systemic inflammatory response syndrome, urosepsis), stone clearance rate and the need for auxiliary treatment are compared.
Primary study endpoint: The renal pelvic pressure. Secondary endpoint: Postoperative systemic inflammatory response syndrome or urosepsis, stone clearance rate, operation time, hospital stay.
Demographic characteristics include age, sex, BMI, stone size and location, etc.
Stone size is defined as the maximum diameter. Operation time is recorded from the time of the first percutaneous renal puncture to the completion of the stone removal.
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) and Postoperative comfort scores (Bruggrmann comfort scale \[BCS\]) will be recorded.
The rate of hemoglobin decrease is assessed by comparing the preoperative Hb level with 24-hour postoperative Hb level.
Primary SFR and final SFR is assessed by KUB at day 1 and 1 month after operation.
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 ≦ 3mm, asymptomatic, non-obstructive and non-infectious stone particles.
If the procedure is considered as successful, the double J stent is removed as outpatient after 2 weeks. Follow-up including KUB or non-contrast CT will be generally scheduled in 1 month.
Bleeding severity is judged by the treating physician, and transfusions are administered according to local practice guideline.
Complications of all patients are recorded according to modified Clavien classification system.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
OTHER
TRIPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
SMP with F14 sheath
Patients undergo Super-Mini Percutaneous Nephrolithotomy with F14 suction-evacuation sheath.
Super-Mini Percutaneous Nephrolithotomy
Patients undergo Super-Mini Percutaneous Nephrolithotomy
SMP with F12 sheath
Patients undergo Super-Mini Percutaneous Nephrolithotomy with F12 suction-evacuation sheath.
Super-Mini Percutaneous Nephrolithotomy
Patients undergo Super-Mini Percutaneous Nephrolithotomy
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Super-Mini Percutaneous Nephrolithotomy
Patients undergo Super-Mini Percutaneous Nephrolithotomy
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
2. Anesthesia rating(ASA) score 1 and 2
3. No obvious preoperative symptoms of infection(chills, fever, etc.)
4. Symptomatic renal calculi and diameter smaller than 25mm
Exclusion Criteria
2. Hydronephrosis
3. Ureteral calculi or urinary tract anomalies, stricture or obstruction
4. Abdominal cavity effusion affecting breathe
5. Patients with congenital anomalies, e.g. ectopic kidney, polycystic
6. Patients who underwent transplant or urinary diversion
7. Uncorrected coagulopathy
8. Patient undergoing any other surgical procedure during the same admission. (e.g. ureteroscopy)
18 Years
70 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
The First Affiliated Hospital of Guangzhou Medical University
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Guohua Zeng
Vice President of the Hospital
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Guohua Zeng, PH.D and M.D
Role: STUDY_CHAIR
The First Affiliated Hospital of Guangzhou Medical University
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
epartment of Urology, Minimally Invasive Surgery Center, The First Affiliated Hospital of Guangzhou Medical University
Guangzhou, Guangdong, China
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
MRER(14)2016
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.