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

December 8, 2023 updated by: bassem metwally

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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:

  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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
182

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
    • Helwan
      • Cairo, Helwan, Egypt, 22435
        • Helwan University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: percutaneous nephrolithotomy
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

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.

Other Names:
  • flexible ureteroscope
Active Comparator: retrograde intrarenal surgery
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

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.

Other Names:
  • flexible ureteroscope

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
one month

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
complications
Time Frame: two weeks
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
operation time
Time Frame: during procedure ( till five hours)
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)
hospital stay
Time Frame: from the day of procedure till the day of discharge from hospital (two weeks)
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)
analgesic use
Time Frame: from the day of procedure till the day of discharge from hospital (two weeks)
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)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
bassem metwally

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Helwan University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: bassem A metwally, master, Helwan University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 2, 2020

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 10, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 15, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 21, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 8, 2023

First Posted (Estimated)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 19, 2023

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 19, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 8, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 72 - 2020

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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