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

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: Active, not recruiting
• Conditions: Health Related Quality of Life
• Intervention / Treatment: Other: SF- 36 Questionnaire

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: Observational
• Enrollment (Anticipated): 200

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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

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

Collaborators and Investigators

• Sponsor: South Valley University

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2021
• Primary Completion (Anticipated): July 15, 2023
• Study Completion (Anticipated): August 1, 2023

Study Registration Dates

• First Submitted: May 1, 2023
• First Submitted That Met QC Criteria: May 1, 2023
• First Posted (Actual): May 9, 2023

Study Record Updates

• Last Update Posted (Actual): May 9, 2023
• Last Update Submitted That Met QC Criteria: May 1, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Keywords: quality of life , PCNL , RIRS
• Other Study ID 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