Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 10:37 PM
Ignite Modification Date:
2025-12-24 @ 10:37 PM
NCT ID:
NCT04345835
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.
Study:
NCT04345835
Study Brief:
Protocol Section:
NCT04345835