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The Influence of SMP on Renal Pelvic Pressure In Vivo

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ClinicalTrials.gov Identifier: NCT02760134
Recruitment Status : Unknown
Verified February 2017 by Guohua Zeng, The First Affiliated Hospital of Guangzhou Medical University.
Recruitment status was:  Recruiting
First Posted : May 3, 2016
Last Update Posted : February 13, 2017
Sponsor:
Information provided by (Responsible Party):
Guohua Zeng, The First Affiliated Hospital of Guangzhou Medical University

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.


Condition or disease Intervention/treatment Phase
Renal Calculi Procedure: Super-Mini Percutaneous Nephrolithotomy Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Other
Official Title: The Influence of Super-Mini Percutaneous Nephrolithotomy on Renal Pelvic Pressure In Vivo
Study Start Date : April 2016
Estimated Primary Completion Date : March 2018
Estimated Study Completion Date : March 2018

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Arm Intervention/treatment
SMP with F14 sheath
Patients undergo Super-Mini Percutaneous Nephrolithotomy with F14 suction-evacuation sheath.
Procedure: 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.
Procedure: Super-Mini Percutaneous Nephrolithotomy
Patients undergo Super-Mini Percutaneous Nephrolithotomy




Primary Outcome Measures :
  1. The renal pelvic pressure [ Time Frame: Every one second intraoperatively ]
    The measurement of renal pelvic pressure was collected each second by the computer.


Secondary Outcome Measures :
  1. Postoperative systemic inflammatory response syndrome [ Time Frame: Within 1 month postoperatively ]
    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.

  2. Operation time [ Time Frame: Intraoperatively ]
    Operation time is the duration of the operation from the time of the first percutaneous renal puncture to the completion of the stone removal.

  3. Hospital stay [ Time Frame: Within 1 month postoperatively ]
    Hospital stay is rounded to the nearest whole day and calculated from the day of surgery to the day of discharge.

  4. Hemoglobin decrease [ Time Frame: Within 24 hours after the operation ]
    The rate of hemoglobin decrease is assessed by comparing the preoperative Hb level with 24-hour postoperative Hb level.

  5. Stone-free status [ Time Frame: Within 1 month postoperatively ]
    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.



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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Age 18 to 70 years
  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:

  1. Couldn't tolerate SMP
  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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02760134


Contacts
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Contact: Guohua Zeng, PH.D and M.D +86 13802916676 gzgyzgh@vip.tom.com
Contact: Junhong Fan +86 18027330778 18027330778@163.com

Locations
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China, Guangdong
epartment of Urology, Minimally Invasive Surgery Center, The First Affiliated Hospital of Guangzhou Medical University Recruiting
Guangzhou, Guangdong, China, 510230
Contact: Guohua Zeng, Ph.D and M.D    +86 13802916676    gzgyzgh@vip.tom.com   
Principal Investigator: Guohua Zeng, Ph.D and M.D         
Sub-Investigator: Junhong Fan         
Sponsors and Collaborators
The First Affiliated Hospital of Guangzhou Medical University
Investigators
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Study Chair: Guohua Zeng, PH.D and M.D The First Affiliated Hospital of Guangzhou Medical University
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Responsible Party: Guohua Zeng, Vice President of the Hospital, The First Affiliated Hospital of Guangzhou Medical University
ClinicalTrials.gov Identifier: NCT02760134    
Other Study ID Numbers: MRER(14)2016
First Posted: May 3, 2016    Key Record Dates
Last Update Posted: February 13, 2017
Last Verified: February 2017
Keywords provided by Guohua Zeng, The First Affiliated Hospital of Guangzhou Medical University:
Super-Mini Percutaneous Nephrolithotomy(SMP)
Renal Pelvic Pressure
Additional relevant MeSH terms:
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Kidney Calculi
Nephrolithiasis
Calculi
Pathological Conditions, Anatomical
Kidney Diseases
Urologic Diseases
Urolithiasis
Urinary Calculi