Prone Flexed Position in Percutanous Nephrolithotomy

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

prone flexed position in percutanous nephrolithotomy in comparsion with standard prone position. A randomized controlled trial.

Study Overview

• Status: Completed
• Conditions: Renal Stones
• Intervention / Treatment: Procedure: Percutanous nephrolithotomy (PCNL)

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 Type: Interventional
• Enrollment (Actual): 300
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Kafrelsheikh
    • Kafr Ash Shaykh, Kafrelsheikh, Egypt
      • Kafrelsheikh Faculty of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 66 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: prone flexed; prone flexed PCNL position	Procedure: Percutanous nephrolithotomy (PCNL); different procedure positioning; Other Names: PNL
Active Comparator: prone; prone position PCNL	Procedure: Percutanous nephrolithotomy (PCNL); different procedure positioning; Other Names: PNL

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Kafrelsheikh University

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2018
• Primary Completion (Actual): April 1, 2020
• Study Completion (Actual): April 1, 2020

Study Registration Dates

• First Submitted: April 12, 2020
• First Submitted That Met QC Criteria: April 12, 2020
• First Posted (Actual): April 14, 2020

Study Record Updates

• Last Update Posted (Actual): April 15, 2020
• Last Update Submitted That Met QC Criteria: April 13, 2020
• Last Verified: April 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Kidney Diseases; Urologic Diseases; Pathological Conditions, Anatomical; Urolithiasis; Urinary Calculi; Calculi; Kidney Calculi; Nephrolithiasis
• Other Study ID Numbers: RS/19.20

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No