Prone Flexed Position in Percutanous Nephrolithotomy
Primary Purpose
Renal Stones
Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Percutanous nephrolithotomy (PCNL)
Sponsored by
About this trial
This is an interventional treatment trial for Renal Stones
Eligibility 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
Sites / Locations
- Kafrelsheikh faculty of medicine
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
prone flexed
prone
Arm Description
prone flexed PCNL position
prone position PCNL
Outcomes
Primary Outcome Measures
position complications
Comparing the prone with the prone-flexed position for PCNL reporting complications using the Clavien-Dindo system
Secondary Outcome Measures
stone score system
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
stone characteristics
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)
stone volume
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).
hemostatic measures
Investigate the effect of antifibrinolytic tranexamic acid usage on blood loss during PCNL.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04345835
Brief Title
Prone Flexed Position in Percutanous Nephrolithotomy
Official Title
Prone Flexed Position in Percutanous Nephrolithotomy in Comparsion With Standard Prone Position. A Randomized Controlled Trial.
Study Type
Interventional
2. Study Status
Record Verification Date
April 2020
Overall Recruitment Status
Completed
Study Start Date
April 1, 2018 (Actual)
Primary Completion Date
April 1, 2020 (Actual)
Study Completion Date
April 1, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Kafrelsheikh University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
prone flexed position in percutanous nephrolithotomy in comparsion with standard prone position. A randomized controlled trial.
Detailed Description
Patients meeting the inclusion criteria will be randomly allocated to 2 groups:
1st group will undergo prone-flexed PCNL.
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
Detailed medical history
Physical examination
Routine blood examination
Urinalysis & urine cytology
Renal and liver function tests
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Renal Stones
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Care Provider
Allocation
Randomized
Enrollment
300 (Actual)
8. Arms, Groups, and Interventions
Arm Title
prone flexed
Arm Type
Active Comparator
Arm Description
prone flexed PCNL position
Arm Title
prone
Arm Type
Active Comparator
Arm Description
prone position PCNL
Intervention Type
Procedure
Intervention Name(s)
Percutanous nephrolithotomy (PCNL)
Other Intervention Name(s)
PNL
Intervention Description
different procedure positioning
Primary Outcome Measure Information:
Title
position complications
Description
Comparing the prone with the prone-flexed position for PCNL reporting complications using the Clavien-Dindo system
Time Frame
end of the study
Secondary Outcome Measure Information:
Title
stone score system
Description
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
Time Frame
end of the study
Title
stone characteristics
Description
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)
Time Frame
end of the study
Title
stone volume
Description
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).
Time Frame
end of the study
Title
hemostatic measures
Description
Investigate the effect of antifibrinolytic tranexamic acid usage on blood loss during PCNL.
Time Frame
end of the study
10. Eligibility
Sex
All
Gender Based
Yes
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Diaa Eldin Taha, MD
Organizational Affiliation
Lecturer of urology
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kafrelsheikh faculty of medicine
City
Kafr Ash Shaykh
State/Province
Kafrelsheikh
Country
Egypt
12. IPD Sharing Statement
Plan to Share IPD
No
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Prone Flexed Position in Percutanous Nephrolithotomy
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