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Prone Flexed Position in Percutanous Nephrolithotomy

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ClinicalTrials.gov Identifier: NCT04345835
Recruitment Status : Completed
First Posted : April 14, 2020
Last Update Posted : April 15, 2020
Sponsor:
Information provided by (Responsible Party):
Diaa Eldin Taha Ramadan Mohamed, Kafrelsheikh University

Study Description
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Brief Summary:
prone flexed position in percutanous nephrolithotomy in comparsion with standard prone position. A randomized controlled trial.

Condition or disease Intervention/treatment Phase
Renal Stones Procedure: Percutanous nephrolithotomy (PCNL) Not Applicable

Detailed Description:

Patients meeting the inclusion criteria will be randomly allocated to 2 groups:

  1. 1st group will undergo prone-flexed PCNL.
  2. 2nd group will undergo prone PCNL.

III. Recruitment of participants Patients appointed for an outpatient diagnostic cystoscopy will be reviewed for the inclusion and exclusion criteria. Legible patients will be asked to participate in the study and to sign the informed consent form.

IV. Randomisation Randomization will be performed using computer generated random tables using stratified blocked randomization in 1:1 ratio.

V. Study procedure Preoperative evaluations included

  1. Detailed medical history
  2. Physical examination
  3. Routine blood examination
  4. Urinalysis & urine cytology
  5. Renal and liver function tests
  6. Coagulation profile

8. Computed tomography of the abdomen and pelvis

Operative Technique

Prone-flexed positioning i. Retrograde access will be obtained ii. The patient is repositioned prone with adequate padding under the pressure points of the head, chest, knees, and feet.

iii. The table is flexed 30 degrees at the level of the patient's mid lumbar region to open the space between the 12th rib and the posterior iliac crest dropping the gluteal muscles from the working plane.

Ancillary intervention

Patients will receive a 20-mL infiltration of 0.25% bupivacaine. Under fluoroscopic guidance, the local analgesic was infiltrated with a 22-gauge spinal needle (10-cm length) along the nephrostomy tract at the 3, 6, 9, and 12 o'clock positions (5 mL in each tract), including the muscles, subcutaneous tissue, and skin.

Patients will receive 1 g tranexamic acid at induction followed by three further doses of 500 mg over the next 24 h.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Care Provider)
Primary Purpose: Treatment
Official Title: Prone Flexed Position in Percutanous Nephrolithotomy in Comparsion With Standard Prone Position. A Randomized Controlled Trial.
Actual Study Start Date : April 1, 2018
Actual Primary Completion Date : April 1, 2020
Actual Study Completion Date : April 1, 2020

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Arms and Interventions
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Arm Intervention/treatment
Active Comparator: prone flexed
prone flexed PCNL position
 Procedure: Percutanous nephrolithotomy (PCNL)
different procedure positioning
Other Name: PNL
Active Comparator: prone
prone position PCNL
 Procedure: Percutanous nephrolithotomy (PCNL)
different procedure positioning
Other Name: PNL


Outcome Measures
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Primary Outcome Measures :
  1. position complications [ Time Frame: end of the study ]
    Comparing the prone with the prone-flexed position for PCNL reporting complications using the Clavien-Dindo system


Secondary Outcome Measures :
  1. stone score system [ Time Frame: end of the study ]
    Comparison of the Guy's (19)" combines the number of stones, their location, and abnormal patient anatomy into a score 1-4", S.T.O.N.E. (20)"uses the stone size, tract length, obstruction, number of calyces involved, and stone density from patient's preoperative CT scan", and CROES (21) "a continuous variable calculated by stone characteristics, patient data, and surgeon/centre experience" Scores for predicting outcomes following PCNL

  2. stone characteristics [ Time Frame: end of the study ]
    Explore the relationship between stone density using various HU values "highest HU value (HUmax), lowest HU value (HUmin) and average HU value (HUave)"on and outcomes of percutaneous nephrolithotomy (PCNL)

  3. stone volume [ Time Frame: end of the study ]
    Assess the impact of the ellipsoid volume of the stone [volume = π/6*(AP*H*CC)] after measuring the antero-posterior and horizontal dimensions in the axial images and the cranio-caudal dimension in the coronal images on and outcomes of percutaneous nephrolithotomy (PCNL).

  4. hemostatic measures [ Time Frame: end of the study ]
    Investigate the effect of antifibrinolytic tranexamic acid usage on blood loss during PCNL.


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

Inclusion Criteria:

  • Large renal or upper ureteral calculi or both,

Exclusion Criteria:

  • (1) Age <18 years or Pregnancy (2) Ureter pelvic junction obstruction (3) Bilateral simultaneous PCNL (4) Need for 3 percutaneous tracts intraoperative (5) Morbid obesity (BMI >40) (6) Non opaque renal stones. (7)Refuse to complete study requirements (8)Untreated UTI (9)Atypical bowel interposition by CT (10)Tumour in the presumptive access tract area or Potential malignant kidney tumour
Contacts and Locations
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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): NCT04345835


Locations
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Egypt
Kafrelsheikh faculty of medicine
Kafr Ash Shaykh, Kafrelsheikh, Egypt
Sponsors and Collaborators
Kafrelsheikh University
Investigators
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Principal Investigator: Diaa Eldin Taha, MD Lecturer of urology
More Information
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Responsible Party: Diaa Eldin Taha Ramadan Mohamed, Lecturer of urology, Kafrelsheikh University
ClinicalTrials.gov Identifier: NCT04345835    
Other Study ID Numbers: RS/19.20
First Posted: April 14, 2020    Key Record Dates
Last Update Posted: April 15, 2020
Last Verified: April 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Kidney Calculi
Nephrolithiasis
Kidney Diseases
Urologic Diseases
 Urolithiasis
Urinary Calculi
Calculi
Pathological Conditions, Anatomical