Changes Post Percutaneous Nephrolithotomy (KUB)

Evaluation of Changes of Renal Morphology, Renal Function and Renal Doppler Parameters Post-percutaneous Nephrolithotomy - A Prospective Case Series Study

Using color doppler U/S, Abdominal U/S and radioisotope to evaluate changes of renal morphology, function and doppler parameters post Percutaneous nephrolithotomy

Study Overview

• Status: Not yet recruiting
• Conditions: Renal Stone

Detailed Description

Preoperative assessment:

Detailed history: including history of medical comorbidities, previous history of stone disease or previous treatment of renal stones.

Complete physical examination with measurement and documentation of the pre-operative blood pressure for all patients.

Estimation of body mass index (BMI).

Pre-operative laboratory investigations including:

Complete urine analysis Urine culture and sensitivity test Complete blood picture (CBC). Prothrombin time and prothrombin concentration. Serum urea and creatinine Random blood sugar -Pre-operative imaging investigations: Plain KUB( Number, site, size and radio-opacity of Stones) Abdominal ultrasound ( Dimensions, Shape, borders, contour, orientation & echogenicity, hydronephrosis, stones & others eg. Cysts) Multi-slice computed tomography (MSCT) abdomen and pelvis without contrast. (Dimensions, Shape, borders, contour, orientation, number, site, size, laterality and density of stones) Color Doppler Ultrasonography ( Renal arteries caliber, outline, resistive index, intrarenal arterial waveforms acceleration time& peak systolic velocity) Radioisotope scan (DMSA scan)

-Procedural steps and techniques: Patients with urinary tract infections will be treated with the appropriate antibiotics according to urine culture and sensitivity test until negative culture is obtained.

Percutaneous nephrolithotomy (PCNL) will be performed in prone/supine position under general or spinal anesthesia after insertion of a ureteral catheter to the affected site.

Access will be done under fluoroscopic guidance. Tract dilatation will be done by using either balloon dilator or Amplatz teflon dilators then Amplatz will be inserted.

Stone disintegration after well established track will be done by using either pneumatic or ultrasonic or laser lithotripters.

Stone retrieval will be done by either forceps or Zero-tip dormia basket. At the end of the procedure, plastic tube 22 French may be inserted through the Amplatz sheath as nephrostomy tube or not (tubeless).

Intraoperatively: we record operative time, anaesthesia time, site of renal puncture, puncture relation to last rib, dilatation method, teflon dilatation steps, number of accesses, disintegration methods, use of flexible nephroscope, intraoperative blood transfusion, nephrostomy tube, state of nephrostomy tube when open and perioperative complications.

Post-operative care and follow up:

Plain KUB, abdominal ultrasound, CBC, prothrombin time and concentration & serum creatinine will be done at Day 1 postoperatively.

Measurement of blood pressure at day 1 postoperatively. Abdominal ultrasonography&Color Doppler Ultrasonography at Day 1, Day 7 and Day 90 postoperatively.

Radioisotope scan (DMSA scan) at day 90 postoperatively. Urine analysis

• Study Type: Observational
• Enrollment (Estimated): 60

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

Patients with renal stones that are candidates for PCNL >18 years old

Description

Inclusion Criteria:

• Adult patients with age group ≥ 18 years old with renal stones candidate for PCNL.

Exclusion Criteria:

1. Patients with any previous intervention to extract the renal stones.
2. Patients with malrotated/anomalous kidney.
3. Patients with any grade of chronic kidney disease.
4. Patients with bleeding diathesis.
5. Patients who are unfit for surgery.
6. Pregnancy
7. Patients who are refusing the participation in our study.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes of renal function post percutaneous nephrolithotomy	Radioisotope scan (DMSA scan) Split function in %	3 months
Changes of renal doppler parameters after percutaneous nephrolithotomy.	Measured by Resistive Index	3 months

Collaborators and Investigators

• Sponsor: Assiut University

Study record dates

Study Major Dates

• Study Start (Estimated): March 1, 2024
• Primary Completion (Estimated): March 1, 2024
• Study Completion (Estimated): May 1, 2025

Study Registration Dates

• First Submitted: November 12, 2023
• First Submitted That Met QC Criteria: December 27, 2023
• First Posted (Actual): December 29, 2023

Study Record Updates

• Last Update Posted (Actual): December 29, 2023
• Last Update Submitted That Met QC Criteria: December 27, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Kidney Diseases; Urologic Diseases; Pathological Conditions, Anatomical; Urolithiasis; Urinary Calculi; Calculi; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Kidney Calculi; Nephrolithiasis
• Other Study ID Numbers: Percutaneous*Nephrolithotomy

Drug and device information, study documents

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