Determinants of Health-related Quality of Life for Patients After Renal Lithotripsy: PNL Versus RIRS

May 1, 2023 updated by: Mostafa AbdelRazek, South Valley University

Determinants of Health-related Quality of Life for Patients After Renal Lithotripsy: Percutaneous Nephrolithotomy (PCNL) Versus Retrograde Intrarenal Surgery(RIRS)

Percutaneous nephrolithotomy (PNL) and Retrograde intrarenal surgery (RIRS) are well-established procedures for renal stone fragmentation; however, the morbidity, hospitalization, and lost work hours associated with these procedures can negatively affect the health-related quality of life (HRQoL) of the patients [1-3].

The choice of modality is based on the European Association of Urology (EAU) and/or American Urological Association (AUA) guidelines. However, selecting a modality is challenging, considering the advantages and drawbacks of both modalities.

RIRS while minimally invasive, has an inferior stone-free rate compared with PNL; however, PNL requires general anesthesia and longer hospitalization [4]. The need to select the therapeutic modality for urinary lithotripsy based not only on the stone-free rate but also on the subsequent HRQoL of the patient is increasingly recognized [5].

The concept of HRQoL is multidimensional, which includes psychosocial, physical, and emotional factors, as well as patient autonomy, and is applicable to a wide variety of medical conditions [6]. Patients with urolithiasis represent an ideal group for the investigation of HRQoL, considering the disease's high prevalence, non-life-threatening nature, severe symptoms, and high recurrence rate [3]. However, only a few longitudinal studies have investigated HRQoL in patients undergoing lithotripsy for urinary calculi [7]. Several studies have evaluated HRQoL using the Short-Form 36-item survey (SF-36) [3, 7-9].

Hence, this study aims to compare longitudinal HRQoL between PNL and RIRS at four timepoints: before surgery (Bef), on the day of discharge (0 mo), and 1 month (1 mo) and 6 months (6 mo) after surgical intervention, and to further investigate the factors that may significantly affect the HRQoL of these patients

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

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

2.4.1- Type of the study: prospective randomized clinical study 2.4. 2- Study Setting: Qena University Hospital 2.4. 3- Study subjects:

  1. Inclusion criteria:

    all patients performing PNL or RIRS for renal stones 2-4 cm

  2. Exclusion criteria:

    Patients refuse to participate in this study Unfit patients Renal Stones more than 4 cm Renal Stones less than 2 cm

  3. Sample Size Calculation:

Not less than 50 patients in each group 2.4.4 -Study tools (in detail, e.g., lab methods, instruments, steps, chemicals, …):

  • Medical history
  • Complete physical examination.
  • Short-Form 36-item survey (SF-36)

  • All patents presented was investigated by

    1. Abdominal U.S
    2. Plain X Ray
    3. Non contrast CT
    4. Serum Creatinine
    5. Urine Analysis

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.
Observational

Enrollment (Anticipated)

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.
200

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
    • Qina
      • Qinā, Qina, Egypt, 831115
        • South Valley 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

N/A

Sampling Method

Probability Sample

Study Population

all patients presented to our clinics will performing PCNL or RIRS 100 patents in each group

Description

Inclusion Criteria:

  • all patients performing PNL or RIRS for renal stones 2-4 cm

Exclusion Criteria:

  • Patients refuse to participate in this study Unfit patients Renal Stones more than 4 cm Renal Stones less than 2 cm

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

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
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.
PCNL
PCNL group applicants will answer SF-36 questionnaire
Other: SF- 36 Questionnaire
applicants will fill health related quality of life SF-36 Questionnaire after PCNL or RIRS
RIRS
RIRS group applicants will answer SF-36 questionnaire
Other: SF- 36 Questionnaire
applicants will fill health related quality of life SF-36 Questionnaire after PCNL or RIRS

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
Determinants of health-related quality of life for patients after renal lithotripsy: PCNL vs RIRS
Time Frame: 2 years
estimate quality of life patients after PCNL and after RIRS
2 years

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.
South Valley 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.
January 1, 2021

Primary Completion (Anticipated)

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.
July 15, 2023

Study Completion (Anticipated)

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.
August 1, 2023

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).
May 1, 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.
May 1, 2023

First Posted (Actual)

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.
May 9, 2023

Study Record Updates

Last Update Posted (Actual)

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.
May 9, 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.
May 1, 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.
May 1, 2023

More Information

Terms related to this study

Keywords

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.
  • SVU/MED/URO016/2.23.4.538

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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