Renal StonesPCNL VS RIRSNCT06175910
Postoperative Outcomes of PCNL vs RIRS in Obese Patients With Pelvic 1.5:3 cm Renal Stones
A study testing percutaneous nephrolithotomy and retrograde intrarenal surgery in people with Renal Stones, run by bassem metwally at 1 site in Egypt.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Renal Stones
- What is being tested?
- percutaneous nephrolithotomy and retrograde intrarenal surgery
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 182 participants
- Where
- 1 siteEgypt
- Study dates
- 2 Dec 2020to 15 Sep 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Obese adult patients with body mass index ≥30
- aged ≥ 18 years
- unilateral pelvic renal stone from 1.5 to 3 cm in largest diameter.
Who cannot join
- 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.)
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- people with severe skeletal deformity
- pregnant women
- history of ureteric strictures
- uncorrectable bleeding disorder.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Safety and Efficacy of Percutaneous Nephrolithotripsy Versus Retrograde Intrarenal Surgery for Obese Patients With Pelvic 1.5:3 cm Renal Stones
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.
Read the 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\'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:
- 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.
- Postoperative fever < 38 degrees.
- Postoperative bleeding.
- Hospital stay from the day of operation till the day of discharge (in days).
- The need for analgesics.
- Conditions
- Renal Stones
- Being tested
- percutaneous nephrolithotomy, retrograde intrarenal surgery
- Keywords
- Renal Stones, Retrograde Intrarenal Surgery (RIRS), Percutaneous Nephrolithotomy (PCNL), Stone-free Rate, Obese Patients
- Medical subject headings
- Nephrolithiasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
percutaneous nephrolithotomyProcedure or surgery
Also called flexible ureteroscope
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 surgeryProcedure or surgery
Also called flexible ureteroscope
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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. Receives: Procedure: retrograde intrarenal surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: one month
Secondary outcomes (4)
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.
Measured: two weeks
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.
Measured: during procedure ( till five hours)
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.
Measured: from the day of procedure till the day of discharge from hospital (two weeks)
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.
Measured: from the day of procedure till the day of discharge from hospital (two weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2023
- Study start2 Dec 2020
- Primary completion10 Aug 2022
- Study completion15 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Renal StonesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 182 participants (actual)
Sponsor and investigators
- Lead sponsor
- bassem metwally
- Sponsor type
- University, hospital or other
- Collaborators
- Helwan University
- Responsible party
- Sponsor-investigator, bassem metwally, Helwan University
- Investigators
- bassem A metwally, master, Principal investigator, Helwan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06175910
- Sponsor's protocol ID
- 72 - 2020
- Acronym
- PCNL VS RIRS
- Status last verified
- Dec 2023
- First submitted
- 21 Nov 2023
- Last updated
- 19 Dec 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy of Percutaneous Nephrolithotripsy Versus Retrograde Intrarenal Surgery for Obese Patients With Pelvic 1.5:3 cm Renal Stones
- ClinicalTrials.gov ID
- NCT06175910
- Acronym / sponsor ID
- PCNL VS RIRS / 72 - 2020
- Conditions
- Renal Stones
- Keywords
- Renal Stones, Retrograde Intrarenal Surgery (RIRS), Percutaneous Nephrolithotomy (PCNL), Stone-free Rate, Obese Patients
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 182 participants (actual)
- Lead sponsor
- bassem metwallyUniversity, hospital or other
- Collaborators
- Helwan University
- Study start
- 2 Dec 2020 (actual)
- Primary completion
- 10 Aug 2022 (actual)
- Study completion
- 15 Sep 2022 (actual)
- First posted
- 19 Dec 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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\'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:
- 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.
- Postoperative fever < 38 degrees.
- Postoperative bleeding.
- Hospital stay from the day of operation till the day of discharge (in days).
- The need for analgesics.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| percutaneous nephrolithotomy | Active comparator | Procedure: percutaneous nephrolithotomy60 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 |
| retrograde intrarenal surgery | Active comparator | Procedure: retrograde intrarenal surgery60 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Obese adult patients with body mass index ≥30
- aged ≥ 18 years
- unilateral pelvic renal stone from 1.5 to 3 cm in largest diameter.
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| percutaneous nephrolithotomyAlso: flexible ureteroscopeA 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. | Procedure or surgery | percutaneous nephrolithotomy |
| retrograde intrarenal surgeryAlso: flexible ureteroscopeurethrocystoscopy 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. | Procedure or surgery | retrograde intrarenal surgery |
Primary outcome
stone free rate
Time frame: one month
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.
4 secondary outcomes
complications
Time frame: two weeks
operation time
Time frame: during procedure ( till five hours)
hospital stay
Time frame: from the day of procedure till the day of discharge from hospital (two weeks)
analgesic use
Time frame: from the day of procedure till the day of discharge from hospital (two weeks)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
bassem A metwally, master principal investigator
Helwan University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing percutaneous nephrolithotomy and retrograde intrarenal surgery in people with Renal Stones, run by bassem metwally at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
stone free rate (time frame: one month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Dec 2023.