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

NCT06175910 | Completed DMC

• 1 other identifier: 72 - 2020
• Study Type: interventional
• Target: 182
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Renal Stones

Keywords

Renal Stones; Retrograde Intrarenal Surgery (RIRS); Percutaneous Nephrolithotomy (PCNL); Stone-free Rate; Obese Patients

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• complications

  two weeks

• operation time

  during procedure ( till five hours)

• hospital stay

  from the day of procedure till the day of discharge from hospital (two weeks)

• analgesic use

  from the day of procedure till the day of discharge from hospital (two weeks)

Study Arms (2)

percutaneous nephrolithotomy

ACTIVE COMPARATOR

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

Procedure: percutaneous nephrolithotomy

retrograde intrarenal surgery

ACTIVE COMPARATOR

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.

Procedure: retrograde intrarenal surgery

Interventions

percutaneous nephrolithotomy PROCEDURE

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.

Also known as: flexible ureteroscope

percutaneous nephrolithotomy

retrograde intrarenal surgery PROCEDURE

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.

Also known as: flexible ureteroscope

retrograde intrarenal surgery

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• bassem metwally: lead
• Helwan University: collaborator

Study Sites (1)

Helwan University

Cairo, Helwan, 22435, Egypt

Location

MeSH Terms

Conditions

Nephrolithiasis

Interventions

Nephrolithotomy, Percutaneous

Condition Hierarchy (Ancestors)

Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urolithiasis; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Laparoscopy; Endoscopy; Minimally Invasive Surgical Procedures; Surgical Procedures, Operative; Urologic Surgical Procedures; Urogenital Surgical Procedures

Study Officials

• bassem A metwally, master

  Helwan University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 21, 2023
• First Posted: December 19, 2023
• Study Start: December 2, 2020
• Primary Completion: August 10, 2022
• Study Completion: September 15, 2022
• Last Updated: December 19, 2023

Record last verified: 2023-12

Locations

EG (1)