Clinical trial NCT06175910: Postoperative Outcomes of PCNL vs RIRS in Obese Patients With Pelvic 1.5:3 cm Renal Stones
Official title: Safety and Efficacy of Percutaneous Nephrolithotripsy Versus Retrograde Intrarenal Surgery for Obese Patients With Pelvic 1.5:3 cm Renal Stones
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Renal Stones
Keywords: Renal Stones
Retrograde Intrarenal Surgery (RIRS)
Percutaneous Nephrolithotomy (PCNL)
Stone-free Rate
Obese Patients
Lead sponsor: Helwan University
Sponsor class: OTHER
Collaborators: name: Helwan University
First posted: 2023-12-19
Enrollment: 182
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Detailed 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\&#39;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.

Eligibility criteria: 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.

Primary outcomes:
measure: stone free rate
timeFrame: one month
Secondary outcomes:
measure: complications
timeFrame: two weeks
measure: operation time
timeFrame: during procedure ( till five hours)
measure: hospital stay
timeFrame: from the day of procedure till the day of discharge from hospital (two weeks)
measure: analgesic use
timeFrame: from the day of procedure till the day of discharge from hospital (two weeks)
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Helwan University
state: Helwan
Study officials:
affiliation: Helwan University
name: bassem A metwally, master
role: PRINCIPAL_INVESTIGATOR
References: