Clinical trial NCT04345835: 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
Overall status: COMPLETED
Phase: NA
Conditions: Renal Stones
Lead sponsor: Kafrelsheikh University
Sponsor class: OTHER
First posted: 2020-04-14
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: position complications
timeFrame: end of the study
Secondary outcomes:
measure: stone score system
timeFrame: end of the study
measure: stone characteristics
timeFrame: end of the study
measure: stone volume
timeFrame: end of the study
measure: hemostatic measures
timeFrame: end of the study
Other outcomes:
Locations:
city: Kafr Ash Shaykh
country: Egypt
facility: Kafrelsheikh faculty of medicine
state: Kafrelsheikh
Study officials:
affiliation: Lecturer of urology
name: Diaa Eldin Taha, MD
role: PRINCIPAL_INVESTIGATOR
References: