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

Health Related Quality of Life Clinical Trial

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

Status Active, not recruiting

Clinical Trial Summary

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

Clinical Trial 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 ;

Related Conditions & MeSH terms

• Health Related Quality of Life

• NCT number: NCT05851339
• Study type: Observational
• Source: South Valley University
• Status: Active, not recruiting
• Start date: January 1, 2021
• Completion date: August 1, 2023