The Influence of SMP on Renal Pelvic Pressure In Vivo
The Influence of Super-Mini Percutaneous Nephrolithotomy on Renal Pelvic Pressure In Vivo
1 other identifier
interventional
100
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Apr 2016
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2016
CompletedFirst Submitted
Initial submission to the registry
April 30, 2016
CompletedFirst Posted
Study publicly available on registry
May 3, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2018
CompletedFebruary 13, 2017
February 1, 2017
1.9 years
April 30, 2016
February 10, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
The renal pelvic pressure
The measurement of renal pelvic pressure was collected each second by the computer.
Every one second intraoperatively
Secondary Outcomes (5)
Postoperative systemic inflammatory response syndrome
Within 1 month postoperatively
Operation time
Intraoperatively
Hospital stay
Within 1 month postoperatively
Hemoglobin decrease
Within 24 hours after the operation
Stone-free status
Within 1 month postoperatively
Study Arms (2)
SMP with F14 sheath
OTHERPatients undergo Super-Mini Percutaneous Nephrolithotomy with F14 suction-evacuation sheath.
SMP with F12 sheath
OTHERPatients undergo Super-Mini Percutaneous Nephrolithotomy with F12 suction-evacuation sheath.
Interventions
Patients undergo Super-Mini Percutaneous Nephrolithotomy
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
epartment of Urology, Minimally Invasive Surgery Center, The First Affiliated Hospital of Guangzhou Medical University
Guangzhou, Guangdong, 510230, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Guohua Zeng, PH.D and M.D
The First Affiliated Hospital of Guangzhou Medical University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- OTHER
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Vice President of the Hospital
Study Record Dates
First Submitted
April 30, 2016
First Posted
May 3, 2016
Study Start
April 1, 2016
Primary Completion
March 1, 2018
Study Completion
March 1, 2018
Last Updated
February 13, 2017
Record last verified: 2017-02