Prone Flexed Position in Percutanous Nephrolithotomy

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

Detailed Description
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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.

Official Title
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Prone Flexed Position in Percutanous Nephrolithotomy in Comparsion With Standard Prone Position. A Randomized Controlled Trial.

Conditions
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Renal Stones

Intervention / Treatment
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* Procedure: Percutanous nephrolithotomy (PCNL)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: prone flexed<br>prone flexed PCNL position | Procedure: Percutanous nephrolithotomy (PCNL)<br>* different procedure positioning<br>* Other names: PNL;|
| Active Comparator: prone<br>prone position PCNL | Procedure: Percutanous nephrolithotomy (PCNL)<br>* different procedure positioning<br>* Other names: PNL;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| position complications | Comparing the prone with the prone-flexed position for PCNL reporting complications using the Clavien-Dindo system | end of the study | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | end of the study | 
| 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) | end of the study | 
| 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). | end of the study | 
| hemostatic measures | Investigate the effect of antifibrinolytic tranexamic acid usage on blood loss during PCNL. | end of the study |