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Prone Flexed Position in Percutanous Nephrolithotomy

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04345835
Enrollment
300
Registered
2020-04-14
Start date
2018-04-01
Completion date
2020-04-01
Last updated
2020-04-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Renal Stones

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: 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.

Interventions

PROCEDUREPercutanous nephrolithotomy (PCNL)

different procedure positioning

Sponsors

Kafrelsheikh University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Caregiver)

Eligibility

Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
position complicationsend of the studyComparing the prone with the prone-flexed position for PCNL reporting complications using the Clavien-Dindo system

Secondary

MeasureTime frameDescription
stone score systemend of the studyComparison 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 characteristicsend of the studyExplore 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 volumeend of the studyAssess 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 measuresend of the studyInvestigate the effect of antifibrinolytic tranexamic acid usage on blood loss during PCNL.

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026