Postoperative Outcomes of PCNL vs RIRS in Obese Patients With Pelvic 1.5:3 cm Renal Stones

Renal Stones Clinical Trial

— PCNL VS RIRS  

Official title:

Safety and Efficacy of Percutaneous Nephrolithotripsy Versus Retrograde Intrarenal Surgery for Obese Patients With Pelvic 1.5:3 cm Renal Stones

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06175910
• Other study ID #: 72 - 2020
• Status: Completed
• Phase: N/A
• Start date: December 2, 2020
• Est. completion date: September 15, 2022

Study information

• Verified date: December 2023
• Source: Helwan University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This prospective randomized comparative study was done at Helwan University Hospital. It was conducted on 120 patients with unilateral pelvic renal stones from 1.5 to 3 cm in largest diameter who was admitted through duration to compare the two procedures differences in terms of complications, analgesic use, hospital stay, operational time, and stone-free rates.

Description:

In this study, 182 patients were assessed for eligibility; 62 patients were excluded, 48 of which were not meeting our inclusion criteria and 14 patients declined to participate in the study as detailed in the CONSORT flowchart After meeting our inclusion and exclusion criteria, 120 patients were thoroughly informed about the study and after feeling well about participating in it a written informed consent was taken from them. Patients were randomly divided into two equal groups using a closed envelope technique into: - Group A: 60 patients were undergone percutaneous nephrolithotomy, three patients were lost in follow up and one case was excluded due to stricture urethra. So, the investigators analysed 56 patients. - Group B: 60 patients were undergone retrograde intrarenal surgery, one patient was lost in follow up and one case was aborted due to narrow ureter & DJ was applied. So, the investigators analysed 58 patients All participants were submitted to preoperative assessment: History-taking, clinical examination, laboratory examination (urine analysis, urine culture and sensitivity, blood urea, creatinine levels, complete blood counts, and coagulation profile), Imaging modalities: ultrasonography, plain radiograph of kidney-ureter-bladder (KUB) and non-contrast computed tomography (CT). The following data were recorded: The information on the patient's characteristics (age and gender), the characteristics of the kidney stones (size and laterality), the length of the procedure in minutes from the induction of anesthesia till the end of procedure (insertion of the nephrostomy in PCNL and the insertion of the urethral catheter in RIRS), and intraoperative complications with a focus on bleeding, stone migration, and extravasation. Postoperative data and follow up: 1. Stone clearance: The patients had radiographic evaluation during the first- and fourth-weeks following surgery, using spiral CT without contrast for radiolucent stones and simple KUB for stones that were radiopaque. Stone-free or stone residual < 3 mm after just one session of the therapy were considered successful outcomes. 2. Postoperative fever < 38 degrees. 3. Postoperative bleeding. 4. Hospital stay from the day of operation till the day of discharge (in days). 5. The need for analgesics.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 182
• Est. completion date: September 15, 2022
• Est. primary completion date: August 10, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Obese adult patients with body mass index =30
• aged = 18 years
• unilateral pelvic renal stone from 1.5 to 3 cm in largest diameter.

Exclusion criteria:

• A single kidney
• renal impairment (serum creatinine > 1.4 mg/dl)
• patients with uncontrolled co-morbidities (hypertension, diabetes mellitus, cardiac disease, chest disease)
• active Urinary tract infection
• ureteric or bladder stones
• anatomic renal abnormalities (congenital renal malformations such as horseshoe kidney, polycystic kidney disease, etc.)
• people with severe skeletal deformity
• pregnant women
• history of ureteric strictures
• uncorrectable bleeding disorder.

Related Conditions & MeSH terms

• Calculi
• Kidney Calculi
• Nephrolithiasis
• Renal Stones

Intervention

Procedure:
• percutaneous nephrolithotomy
A 7 Fr ureteric catheter was placed into the ipsilateral ureteric orifice. The patients were then placed in the prone position. Opacification of the pelvicalyceal system was performed. The puncture was done by a 22-guage puncture needle was advanced into the posterior lower calyx under fluoroscopic guidance. After successful access is established, a 0.035-inch curved guide wire was advanced through the puncture needle into the kidney. The central Alkane Rod was passed over the guide wire. Under fluoroscopic guidance serial Amplatz dilators up to 30 Fr were advanced over central Alkane rod and guide wire. Then 30 Fr long Amplatz sheath was advanced over the last dilator. 26 Fr rigid long nephroscope used for stone fragmentation and retrieval. Stone fragmentation was done by pneumatic Swiss Lithoclast. Fragments removal was done using toothed peanut stone retrieval forceps.
• retrograde intrarenal surgery
urethrocystoscopy was carried out then inserting of a 7F open ended ureteral catheter over the 0.035-inch straight floppy tip guide wire in the working channel of the 22Fr cystoscope under fluoroscopic guidance, access to the ureter was made. Teflon ureteric dilators are used to dilate the distal ureter till 14 FR. ureteral access sheath placement 12 or 14 Fr. OTU, a disposable digital flexible ureteroscope, is then used then the tip of a 272 m holmium laser fiber is placed on the surface of the stone for fragmentation. Intra renal lithotripsy was carried out using a 30 W Holmium: YAG laser (Sphinx Jr.) via a 272 m silica quartz laser fiber. 1.9 Fr tipless nitinol baskets were finally used to remove the large fragments. A Double-J (6 Fr) stent is generally applied at the end of the procedure, and a urethral catheter was applied.

Locations

Country	Name	City	State
Egypt	Helwan University	Cairo	Helwan

Sponsors (2)

Lead Sponsor	Collaborator
bassem metwally	Helwan University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	stone free rate	Stone-free or stone residual < 3 mm after just one session of the therapy were considered successful outcomes.Data were gathered, edited, coded, and entered into IBM SPSS version 23 of the Statistical Package for Social Science.	one month
Secondary	complications	fever >38 ,intra or postoperative bleeding, Pelvicalyceal system injury.Data were gathered, edited, coded, and entered into IBM SPSS version 23 of the Statistical Package for Social Science.	two weeks
Secondary	operation time	the length of the procedure in minutes from the induction of anesthesia till the end of procedure .Data were gathered, edited, coded, and entered into IBM SPSS version 23 of the Statistical Package for Social Science.	during procedure ( till five hours)
Secondary	hospital stay	from the day of operation till the day of discharge (in days).Data were gathered, edited, coded, and entered into IBM SPSS version 23 of the Statistical Package for Social Science.	from the day of procedure till the day of discharge from hospital (two weeks)
Secondary	analgesic use	Number of patients need analgesic in form of non steroidal anti inflammatory drugs. Data were gathered, edited, coded, and entered into IBM SPSS version 23 of the Statistical Package for Social Science.	from the day of procedure till the day of discharge from hospital (two weeks)