The Influence of SMP on Renal Pelvic Pressure In Vivo
Primary Purpose
Renal Calculi
Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Super-Mini Percutaneous Nephrolithotomy
Sponsored by
About this trial
This is an interventional other trial for Renal Calculi focused on measuring Super-Mini Percutaneous Nephrolithotomy(SMP), Renal Pelvic Pressure
Eligibility Criteria
Inclusion Criteria:
- Age 18 to 70 years
- Anesthesia rating(ASA) score 1 and 2
- No obvious preoperative symptoms of infection(chills, fever, etc.)
- Symptomatic renal calculi and diameter smaller than 25mm
Exclusion Criteria:
- Couldn't tolerate SMP
- Hydronephrosis
- Ureteral calculi or urinary tract anomalies, stricture or obstruction
- Abdominal cavity effusion affecting breathe
- Patients with congenital anomalies, e.g. ectopic kidney, polycystic
- Patients who underwent transplant or urinary diversion
- Uncorrected coagulopathy
- Patient undergoing any other surgical procedure during the same admission. (e.g. ureteroscopy)
Sites / Locations
- epartment of Urology, Minimally Invasive Surgery Center, The First Affiliated Hospital of Guangzhou Medical UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Other
Arm Label
SMP with F14 sheath
SMP with F12 sheath
Arm Description
Patients undergo Super-Mini Percutaneous Nephrolithotomy with F14 suction-evacuation sheath.
Patients undergo Super-Mini Percutaneous Nephrolithotomy with F12 suction-evacuation sheath.
Outcomes
Primary Outcome Measures
The renal pelvic pressure
The measurement of renal pelvic pressure was collected each second by the computer.
Secondary Outcome Measures
Postoperative systemic inflammatory response syndrome
Postoperatively patients were monitored for signs of SIRS, which is manifested by two or more of the following conditions: (1)Temperature > 38°C or < 36°C,(2) Heart rate > 90 bpm,(3) Respiratory rate > 20 breaths/min or PaCO2 < 32 mmHg (< 4.3 kPa),(4) WBC > 12,000 cells/mm3 or < 4,000 cells/mm3 or > 10% immature (band) forms.
Operation time
Operation time is the duration of the operation from the time of the first percutaneous renal puncture to the completion of the stone removal.
Hospital stay
Hospital stay is rounded to the nearest whole day and calculated from the day of surgery to the day of discharge.
Hemoglobin decrease
The rate of hemoglobin decrease is assessed by comparing the preoperative Hb level with 24-hour postoperative Hb level.
Stone-free status
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.
Full Information
NCT ID
NCT02760134
First Posted
April 30, 2016
Last Updated
February 10, 2017
Sponsor
The First Affiliated Hospital of Guangzhou Medical University
1. Study Identification
Unique Protocol Identification Number
NCT02760134
Brief Title
The Influence of SMP on Renal Pelvic Pressure In Vivo
Official Title
The Influence of Super-Mini Percutaneous Nephrolithotomy on Renal Pelvic Pressure In Vivo
Study Type
Interventional
2. Study Status
Record Verification Date
February 2017
Overall Recruitment Status
Unknown status
Study Start Date
April 2016 (undefined)
Primary Completion Date
March 2018 (Anticipated)
Study Completion Date
March 2018 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The First Affiliated Hospital of Guangzhou Medical University
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Percutaneous nephrolithotomy (PCNL) is a well-established treatment modality for renal stones. It offers a high stone free rates and less invasive than open surgery. Nevertheless PCNL is an invasive and technically demanding procedure with inherent risks and complications. The most troublesome morbidities are bleeding and injury to the kidney and its adjacent structures. Complications of PCNL tend to be associated with the accuracy of tract placement and the size of the nephrostomy tract. To improve the safety of PCNL, there is a trend toward using smaller and smaller nephrostomy tracts . With the smaller nephrostomy tract, there also arise the problems of compromised visual field and increased difficulty in stone extraction. Increase irrigation using pressure pump might improve the visualization and the passive egress of the stone fragments, but it also may concomitantly increase the intra-luminal pressure.
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.
Detailed Description
To evaluate the influence of SMP on renal pelvic pressure for the treatment of renal calculi measuring smaller than 25 mm. Investigators will do a single center randomized open-label trial,and investigators plan to perform this study in the First Affiliated Hospital of Guangzhou Medical University of China.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Renal Calculi
Keywords
Super-Mini Percutaneous Nephrolithotomy(SMP), Renal Pelvic Pressure
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
SMP with F14 sheath
Arm Type
Other
Arm Description
Patients undergo Super-Mini Percutaneous Nephrolithotomy with F14 suction-evacuation sheath.
Arm Title
SMP with F12 sheath
Arm Type
Other
Arm Description
Patients undergo Super-Mini Percutaneous Nephrolithotomy with F12 suction-evacuation sheath.
Intervention Type
Procedure
Intervention Name(s)
Super-Mini Percutaneous Nephrolithotomy
Intervention Description
Patients undergo Super-Mini Percutaneous Nephrolithotomy
Primary Outcome Measure Information:
Title
The renal pelvic pressure
Description
The measurement of renal pelvic pressure was collected each second by the computer.
Time Frame
Every one second intraoperatively
Secondary Outcome Measure Information:
Title
Postoperative systemic inflammatory response syndrome
Description
Postoperatively patients were monitored for signs of SIRS, which is manifested by two or more of the following conditions: (1)Temperature > 38°C or < 36°C,(2) Heart rate > 90 bpm,(3) Respiratory rate > 20 breaths/min or PaCO2 < 32 mmHg (< 4.3 kPa),(4) WBC > 12,000 cells/mm3 or < 4,000 cells/mm3 or > 10% immature (band) forms.
Time Frame
Within 1 month postoperatively
Title
Operation time
Description
Operation time is the duration of the operation from the time of the first percutaneous renal puncture to the completion of the stone removal.
Time Frame
Intraoperatively
Title
Hospital stay
Description
Hospital stay is rounded to the nearest whole day and calculated from the day of surgery to the day of discharge.
Time Frame
Within 1 month postoperatively
Title
Hemoglobin decrease
Description
The rate of hemoglobin decrease is assessed by comparing the preoperative Hb level with 24-hour postoperative Hb level.
Time Frame
Within 24 hours after the operation
Title
Stone-free status
Description
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.
Time Frame
Within 1 month postoperatively
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Age 18 to 70 years
Anesthesia rating(ASA) score 1 and 2
No obvious preoperative symptoms of infection(chills, fever, etc.)
Symptomatic renal calculi and diameter smaller than 25mm
Exclusion Criteria:
Couldn't tolerate SMP
Hydronephrosis
Ureteral calculi or urinary tract anomalies, stricture or obstruction
Abdominal cavity effusion affecting breathe
Patients with congenital anomalies, e.g. ectopic kidney, polycystic
Patients who underwent transplant or urinary diversion
Uncorrected coagulopathy
Patient undergoing any other surgical procedure during the same admission. (e.g. ureteroscopy)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Guohua Zeng, PH.D and M.D
Phone
+86 13802916676
Email
gzgyzgh@vip.tom.com
First Name & Middle Initial & Last Name or Official Title & Degree
Junhong Fan
Phone
+86 18027330778
Email
18027330778@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Guohua Zeng, PH.D and M.D
Organizational Affiliation
The First Affiliated Hospital of Guangzhou Medical University
Official's Role
Study Chair
Facility Information:
Facility Name
epartment of Urology, Minimally Invasive Surgery Center, The First Affiliated Hospital of Guangzhou Medical University
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510230
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Guohua Zeng, Ph.D and M.D
Phone
+86 13802916676
Email
gzgyzgh@vip.tom.com
First Name & Middle Initial & Last Name & Degree
Guohua Zeng, Ph.D and M.D
First Name & Middle Initial & Last Name & Degree
Junhong Fan
12. IPD Sharing Statement
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The Influence of SMP on Renal Pelvic Pressure In Vivo
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