<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03797027</url>
  </required_header>
  <id_info>
    <org_study_id>Honglin Sun</org_study_id>
    <nct_id>NCT03797027</nct_id>
  </id_info>
  <brief_title>Effects of Abdominal Cushion on PCNL in Prone Position</brief_title>
  <official_title>Effects of Abdominal Cushion on Percutaneous Nephrostolithotomy in Prone Position: a Randomized Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>The First Affiliated Hospital of Guangzhou Medical University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>The First Affiliated Hospital of Guangzhou Medical University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Percutaneous nephrolithotomy (PCNL) is the first choice for the treatment of ≥ 2cm renal&#xD;
      stones. The positions of PCNL includes supine, prone and lateral. PCNL has been performed in&#xD;
      my center for nearly twenty years. The prone position is routinely used. Generally speaking,&#xD;
      an abdominal cushion is used to raise the abdominal in the prone position, in order to&#xD;
      provide an adequate exposure of kidney, increase the intercostal space, decrease the mobility&#xD;
      of kidney and lower the risk of pleura injury. However, there is no consensus and criterion&#xD;
      on the height of abdominal cushion. With largely increased PCNL procedures and various BMI,&#xD;
      precise evaluation of abdominal cushion is needed. In the preliminary work, the investigators&#xD;
      measured the sunken height of waist of 100 patients in the prone position without a abdominal&#xD;
      cushion. The results showed that the mean BMI of 100 patients was 23.45 (16.79-36.98) and the&#xD;
      range of sunken height of waist was 2-7 cm. Therefore, the investigators are planning to&#xD;
      conduct a randomized controlled study to compare the safety and efficacy among no cushion&#xD;
      group, 5 cm cushion group and 10 cm cushion group. To clarify the relationship between height&#xD;
      of abdominal cushion and BMI, the nurse could prepare the appropriate cushion the day before&#xD;
      surgery, which would decrease operating time and accelerate postoperative recovery.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      1. Background Percutaneous nephrolithotomy (PCNL) is the first choice for the treatment of&#xD;
           ≥ 2cm renal stones.The positions of PCNL includes supine, prone and lateral. PCNL has&#xD;
           been performed in my center for nearly twenty years. The prone position is routinely&#xD;
           used. Generally speaking, an abdominal cushion is used to raise the abdominal in the&#xD;
           prone position, in order to provide an adequate exposure of kidney, increase the&#xD;
           intercostal space, decrease the mobility of kidney and lower the risk of pleura injury.&#xD;
           However, there is no consensus and criterion on the height of abdominal cushion. With&#xD;
           largely increased PCNL procedures and various BMI, precise evaluation of abdominal&#xD;
           cushion is needed. In the preliminary work, the investigators measured the sunken height&#xD;
           of waist of 100 patients in the prone position without a abdominal cushion. The results&#xD;
           showed that the mean BMI of 100 patients was 23.45 (16.79-36.98) and the range of sunken&#xD;
           height of waist was 2-7 cm. Therefore, the investigators are planning to conduct a&#xD;
           randomized controlled study to compare the safety and efficacy among no cushion group, 5&#xD;
           cm cushion group and 10 cm cushion group. To clarify the relationship between height of&#xD;
           abdominal cushion and BMI, the nurse could prepare the appropriate cushion the day&#xD;
           before surgery, which would decrease operating time and accelerate postoperative&#xD;
           recovery.&#xD;
&#xD;
        2. Purpose To investigate effects of different height of abdominal cushion on prone PCNL,&#xD;
           in terms of intraoperative parameters. Our study could provide high quality of evidences&#xD;
           on making criteria of perioperative nurse.&#xD;
&#xD;
        3. Design 3.1 Participant： A single randomized controlled study 3.2 Number of cases： 180&#xD;
           patients who are candidates for PCNL will be enrolled in this study. By 1:2 simple&#xD;
           random sampling technique, patients will be assigned to 60-patient no cushion PCNL and&#xD;
           120-patient cushion PCNL (60-patient for 5 cm cushion and 60-patient for 10 cm cushion).&#xD;
&#xD;
           *(Assuming SFR (1 month after procedure) with cushion PCNL of 90% and expected rate of&#xD;
           70% with no cushion PCNL, the sample size for each group are calculated as 120 and 60&#xD;
           [power &gt; 0.90 with a type I error rate &lt; 0.05.]&#xD;
&#xD;
        4. Candidate:&#xD;
&#xD;
           4.1 Included criterion：&#xD;
&#xD;
             -  Willing to receive PCNL&#xD;
&#xD;
             -  Aged 18-70 years&#xD;
&#xD;
             -  Normal renal function&#xD;
&#xD;
             -  ASA scoreⅠ to Ⅱ 4.2 Excluded criterion：&#xD;
&#xD;
             -  Uncorrected coagulopathy and active urinary tract infection (UTI)&#xD;
&#xD;
             -  Patients who underwent transplant or urinary diversion.&#xD;
&#xD;
             -  Congenital abnormalities. 4.3 Excluded from the study after inclusion Patients will&#xD;
                be excluded from the study if the undergoing standard PNL/mini-perc have purulent&#xD;
                fluid in the initial puncture.&#xD;
&#xD;
           Patients with positive preoperative urine culture should be treated with suitable&#xD;
           antibiotics based on the culture sensitivity result for at least 72 h before PCNL.&#xD;
           Patients who have negative urine culture should receive a single dose of broad spectrum&#xD;
           antibiotic prophylaxis just prior to the procedure. Patients who are going to receive&#xD;
           PCNL would get a envelope including a randomized number and consent letter.&#xD;
&#xD;
        5. Surgical technique&#xD;
&#xD;
           Under general anaesthesia, each patient is initially placed in the lithotomy position,&#xD;
           and a 5 Fr or 6Fr ureteral catheter is inserted to the kidney and fixed with a 16 Fr&#xD;
           Foley catheter. Then the patient is turned to the prone position. An abdominal cushion&#xD;
           is used according to the randomized number. The choice of using C-arm fluoroscopic or&#xD;
           ultrasonography guidance or a combination fashion for the percutaneous access was made&#xD;
           at the discretion of the treating urologist. The length of the needle from skin to the&#xD;
           collecting system is measured to ensure that the length of dilator is appropriate. No&#xD;
           patient underwent bilateral simultaneous PCNL and patients with bilateral stones&#xD;
           underwent surgery 4 weeks apart. The access tract is dilated with a fascial dilator from&#xD;
           8F up to 18F. The investigators defined access to the collecting system as gaining entry&#xD;
           to the targeted urinary system and desired calix. For some complex cases, when indicated&#xD;
           requiring multiple tracts, additional tracts were created in the same session. The stone&#xD;
           was fragmented by pneumatic lithotripsy or Holmium:YAG laser lithotripsy through 8/9.8F&#xD;
           semirigid ureteroscope (Richard Wolf, Germany). The large fragments were extracted with&#xD;
           a forceps and small fragments were flushed out with an endoscopic pulsed perfusion pump.&#xD;
           A silastic nephrostomy tube was placed at the end of procedure and a 4-6Fr double&#xD;
           pigtail ureteral stent was left for 2 weeks after operation. X-ray check for residual&#xD;
           stone fragments is also performed at the end of the procedure.&#xD;
&#xD;
           Patients were candidates for the tubeless procedure only when the following strict&#xD;
           conditions were met: single percutaneous tract, absence of major perforation of&#xD;
           collecting system and bleeding, complete stone clearance assessed by intraoperative&#xD;
           nephroscopy and fluoroscopy at the end of the procedure. For a tubeless procedure, the&#xD;
           flank was compressed for 5 min. Patient was monitored for postoperative complications.&#xD;
&#xD;
        6. Data collection&#xD;
&#xD;
      Data for the 2 groups -demographic characteristics, time of puncture and dilation, site of&#xD;
      target calix, site of access, S.T.O.N.E score, hemoglobin drop, postoperative pain, duration&#xD;
      of procedure, hospital stay, cases of tubeless, complications (modified Clavin system), stone&#xD;
      clearance (SFR of postoperative day 1 and 1 month follow-up) and the need for auxiliary&#xD;
      treatment (for example, re-PCNL, RIRS and ESWL) - are compared.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Anticipated">January 1, 2019</start_date>
  <completion_date type="Anticipated">January 1, 2021</completion_date>
  <primary_completion_date type="Anticipated">January 1, 2021</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>time of puncture and dilation</measure>
    <time_frame>intraoperatively</time_frame>
  </primary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Anticipated">180</enrollment>
  <condition>Kidney Stone</condition>
  <arm_group>
    <arm_group_label>No cushion</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Patients in no cushion group undergo prone percutaneous nephrolithotomy without an abdominal cushion</description>
  </arm_group>
  <arm_group>
    <arm_group_label>5 cm cushion</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Patients in 5 cm cushion group undergo prone percutaneous nephrolithotomy with an 5 cm abdominal cushion</description>
  </arm_group>
  <arm_group>
    <arm_group_label>10 cm cushion</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Patients in 10 cm cushion group undergo prone percutaneous nephrolithotomy with an 10 cm abdominal cushion</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Percutaneous Nephrolithotomy without an abdominal cushion</intervention_name>
    <description>patients undergo prone PNCL without an abdominal cushion</description>
    <arm_group_label>No cushion</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Percutaneous Nephrolithotomy with an 5 cm abdominal cushion</intervention_name>
    <description>patients undergo prone PNCL with an 5 cm abdominal cushion</description>
    <arm_group_label>5 cm cushion</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Percutaneous Nephrolithotomy with an 5 cm abdominal cushion</intervention_name>
    <description>patients undergo prone PNCL with an 10 cm abdominal cushion</description>
    <arm_group_label>10 cm cushion</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Willing to receive PCNL&#xD;
&#xD;
          -  Aged 18-70 years&#xD;
&#xD;
          -  Normal renal function&#xD;
&#xD;
          -  ASA scoreⅠ to Ⅱ&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Uncorrected coagulopathy and active urinary tract infection (UTI)&#xD;
&#xD;
          -  Patients who underwent transplant or urinary diversion.&#xD;
&#xD;
          -  Congenital abnormalities.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Guohua Zeng, PH.D &amp; MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>The First Affiliated Hospital of Guangzhou Medical University</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Guohua Zeng, PH.D &amp; MD</last_name>
    <phone>+86 13802916676</phone>
    <email>gzgyzgh@vip.tom.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Chao Cai, PH.D &amp; MD</last_name>
    <phone>+86 13512780911</phone>
    <email>673059209@qq.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Department of Urology, Minimally Invasive Surgery Center, The First Affiliated Hospital of Guangzhou Medical University</name>
      <address>
        <city>Guangzhou</city>
        <state>Guangdong</state>
        <zip>510230</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Guohua Zeng, Ph.D &amp; MD.</last_name>
      <phone>+86 13802916676</phone>
      <email>gzgyzgh@vip.tom.com</email>
    </contact>
    <investigator>
      <last_name>Guohua Zeng, Ph.D &amp; MD.</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Hongling Sun, Ph.D &amp; MD.</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>January 2019</verification_date>
  <study_first_submitted>January 5, 2019</study_first_submitted>
  <study_first_submitted_qc>January 5, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 8, 2019</study_first_posted>
  <last_update_submitted>January 9, 2019</last_update_submitted>
  <last_update_submitted_qc>January 9, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">January 10, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>The First Affiliated Hospital of Guangzhou Medical University</investigator_affiliation>
    <investigator_full_name>Guohua Zeng</investigator_full_name>
    <investigator_title>Vice president</investigator_title>
  </responsible_party>
  <keyword>Percutaneous nephrolithotomy</keyword>
  <keyword>cushion</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Kidney Calculi</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03797027
org study id: Honglin Sun
nct id: NCT03797027
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Percutaneous nephrolithotomy (PCNL) is the first choice for the treatment of ≥ 2cm renal
      stones. The positions of PCNL includes supine, prone and lateral. PCNL has been performed in
      my center for nearly twenty years. The prone position is routinely used. Generally speaking,
      an abdominal cushion is used to raise the abdominal in the prone position, in order to
      provide an adequate exposure of kidney, increase the intercostal space, decrease the mobility
      of kidney and lower the risk of pleura injury. However, there is no consensus and criterion
      on the height of abdominal cushion. With largely increased PCNL procedures and various BMI,
      precise evaluation of abdominal cushion is needed. In the preliminary work, the investigators
      measured the sunken height of waist of 100 patients in the prone position without a abdominal
      cushion. The results showed that the mean BMI of 100 patients was 23.45 (16.79-36.98) and the
      range of sunken height of waist was 2-7 cm. Therefore, the investigators are planning to
      conduct a randomized controlled study to compare the safety and efficacy among no cushion
      group, 5 cm cushion group and 10 cm cushion group. To clarify the relationship between height
      of abdominal cushion and BMI, the nurse could prepare the appropriate cushion the day before
      surgery, which would decrease operating time and accelerate postoperative recovery.
1. Background Percutaneous nephrolithotomy (PCNL) is the first choice for the treatment of
           ≥ 2cm renal stones.The positions of PCNL includes supine, prone and lateral. PCNL has
           been performed in my center for nearly twenty years. The prone position is routinely
           used. Generally speaking, an abdominal cushion is used to raise the abdominal in the
           prone position, in order to provide an adequate exposure of kidney, increase the
           intercostal space, decrease the mobility of kidney and lower the risk of pleura injury.
           However, there is no consensus and criterion on the height of abdominal cushion. With
           largely increased PCNL procedures and various BMI, precise evaluation of abdominal
           cushion is needed. In the preliminary work, the investigators measured the sunken height
           of waist of 100 patients in the prone position without a abdominal cushion. The results
           showed that the mean BMI of 100 patients was 23.45 (16.79-36.98) and the range of sunken
           height of waist was 2-7 cm. Therefore, the investigators are planning to conduct a
           randomized controlled study to compare the safety and efficacy among no cushion group, 5
           cm cushion group and 10 cm cushion group. To clarify the relationship between height of
           abdominal cushion and BMI, the nurse could prepare the appropriate cushion the day
           before surgery, which would decrease operating time and accelerate postoperative
           recovery.

        2. Purpose To investigate effects of different height of abdominal cushion on prone PCNL,
           in terms of intraoperative parameters. Our study could provide high quality of evidences
           on making criteria of perioperative nurse.

        3. Design 3.1 Participant： A single randomized controlled study 3.2 Number of cases： 180
           patients who are candidates for PCNL will be enrolled in this study. By 1:2 simple
           random sampling technique, patients will be assigned to 60-patient no cushion PCNL and
           120-patient cushion PCNL (60-patient for 5 cm cushion and 60-patient for 10 cm cushion).

           *(Assuming SFR (1 month after procedure) with cushion PCNL of 90% and expected rate of
           70% with no cushion PCNL, the sample size for each group are calculated as 120 and 60
           [power > 0.90 with a type I error rate < 0.05.]

        4. Candidate:

           4.1 Included criterion：

             -  Willing to receive PCNL

             -  Aged 18-70 years

             -  Normal renal function

             -  ASA scoreⅠ to Ⅱ 4.2 Excluded criterion：

             -  Uncorrected coagulopathy and active urinary tract infection (UTI)

             -  Patients who underwent transplant or urinary diversion.

             -  Congenital abnormalities. 4.3 Excluded from the study after inclusion Patients will
                be excluded from the study if the undergoing standard PNL/mini-perc have purulent
                fluid in the initial puncture.

           Patients with positive preoperative urine culture should be treated with suitable
           antibiotics based on the culture sensitivity result for at least 72 h before PCNL.
           Patients who have negative urine culture should receive a single dose of broad spectrum
           antibiotic prophylaxis just prior to the procedure. Patients who are going to receive
           PCNL would get a envelope including a randomized number and consent letter.

        5. Surgical technique

           Under general anaesthesia, each patient is initially placed in the lithotomy position,
           and a 5 Fr or 6Fr ureteral catheter is inserted to the kidney and fixed with a 16 Fr
           Foley catheter. Then the patient is turned to the prone position. An abdominal cushion
           is used according to the randomized number. The choice of using C-arm fluoroscopic or
           ultrasonography guidance or a combination fashion for the percutaneous access was made
           at the discretion of the treating urologist. The length of the needle from skin to the
           collecting system is measured to ensure that the length of dilator is appropriate. No
           patient underwent bilateral simultaneous PCNL and patients with bilateral stones
           underwent surgery 4 weeks apart. The access tract is dilated with a fascial dilator from
           8F up to 18F. The investigators defined access to the collecting system as gaining entry
           to the targeted urinary system and desired calix. For some complex cases, when indicated
           requiring multiple tracts, additional tracts were created in the same session. The stone
           was fragmented by pneumatic lithotripsy or Holmium:YAG laser lithotripsy through 8/9.8F
           semirigid ureteroscope (Richard Wolf, Germany). The large fragments were extracted with
           a forceps and small fragments were flushed out with an endoscopic pulsed perfusion pump.
           A silastic nephrostomy tube was placed at the end of procedure and a 4-6Fr double
           pigtail ureteral stent was left for 2 weeks after operation. X-ray check for residual
           stone fragments is also performed at the end of the procedure.

           Patients were candidates for the tubeless procedure only when the following strict
           conditions were met: single percutaneous tract, absence of major perforation of
           collecting system and bleeding, complete stone clearance assessed by intraoperative
           nephroscopy and fluoroscopy at the end of the procedure. For a tubeless procedure, the
           flank was compressed for 5 min. Patient was monitored for postoperative complications.

        6. Data collection

      Data for the 2 groups -demographic characteristics, time of puncture and dilation, site of
      target calix, site of access, S.T.O.N.E score, hemoglobin drop, postoperative pain, duration
      of procedure, hospital stay, cases of tubeless, complications (modified Clavin system), stone
      clearance (SFR of postoperative day 1 and 1 month follow-up) and the need for auxiliary
      treatment (for example, re-PCNL, RIRS and ESWL) - are compared.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: time of puncture and dilation
time frame: intraoperatively
arm group label: No cushion
arm group type: Other
description: Patients in no cushion group undergo prone percutaneous nephrolithotomy without an abdominal cushion
arm group label: 5 cm cushion
arm group type: Other
description: Patients in 5 cm cushion group undergo prone percutaneous nephrolithotomy with an 5 cm abdominal cushion
arm group label: 10 cm cushion
arm group type: Other
description: Patients in 10 cm cushion group undergo prone percutaneous nephrolithotomy with an 10 cm abdominal cushion
intervention type: Device
intervention name: Percutaneous Nephrolithotomy without an abdominal cushion
description: patients undergo prone PNCL without an abdominal cushion
arm group label: No cushion
intervention type: Device
intervention name: Percutaneous Nephrolithotomy with an 5 cm abdominal cushion
description: patients undergo prone PNCL with an 5 cm abdominal cushion
arm group label: 5 cm cushion
intervention type: Device
intervention name: Percutaneous Nephrolithotomy with an 5 cm abdominal cushion
description: patients undergo prone PNCL with an 10 cm abdominal cushion
arm group label: 10 cm cushion
criteria: 
gender: All
minimum age: 18 Years
maximum age: 70 Years
healthy volunteers: No
last name: Guohua Zeng, PH.D & MD
role: Principal Investigator
affiliation: The First Affiliated Hospital of Guangzhou Medical University
last name: Guohua Zeng, PH.D & MD
phone: +86 13802916676
email: gzgyzgh@vip.tom.com
last name: Chao Cai, PH.D & MD
phone: +86 13512780911
email: 673059209@qq.com
facility: 
status: Recruiting
contact: 
investigator: 
investigator: 
country: China
responsible party type: Principal Investigator
investigator affiliation: The First Affiliated Hospital of Guangzhou Medical University
investigator full name: Guohua Zeng
investigator title: Vice president
mesh term: Kidney Calculi