Prone Flexed Position in Percutanous Nephrolithotomy

NCT ID: NCT04345835

Last Updated: 2020-04-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 300 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-04-01
• Study Completion Date: 2020-04-01

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.

Conditions

Renal Stones

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

prone flexed

prone flexed PCNL position

Group Type: ACTIVE_COMPARATOR

Percutanous nephrolithotomy (PCNL)

Intervention Type: PROCEDURE

different procedure positioning

prone

prone position PCNL

Group Type: ACTIVE_COMPARATOR

Percutanous nephrolithotomy (PCNL)

Intervention Type: PROCEDURE

different procedure positioning

Interventions

Percutanous nephrolithotomy (PCNL)

different procedure positioning

Intervention Type: PROCEDURE

Other Intervention Names

PNL

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Kafrelsheikh University

OTHER

Sponsor Role: lead

Responsible Party

Diaa Eldin Taha Ramadan Mohamed

Lecturer of urology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Diaa Eldin Taha, MD

Role: PRINCIPAL_INVESTIGATOR

Lecturer of urology

Locations

Kafrelsheikh faculty of medicine

Kafr ash Shaykh, Kafrelsheikh, Egypt

Countries

Egypt

Other Identifiers

RS/19.20

Identifier Type: -

Identifier Source: org_study_id