Clinical Trial Details
— Status: Not yet recruiting
Administrative data
| NCT number |
NCT06185387 |
| Other study ID # |
Percutaneous*Nephrolithotomy |
| Secondary ID |
|
| Status |
Not yet recruiting |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
March 1, 2024 |
| Est. completion date |
May 1, 2025 |
Study information
| Verified date |
December 2023 |
| Source |
Assiut University |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational [Patient Registry]
|
Clinical Trial Summary
Using color doppler U/S, Abdominal U/S and radioisotope to evaluate changes of renal
morphology, function and doppler parameters post Percutaneous nephrolithotomy
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
