NCT05851339

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)

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 200 (estimated)
• Sponsor: South Valley University · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: —

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

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

Conditions

• Health Related Quality of Life

Interventions

Type	Name	Description
OTHER	SF- 36 Questionnaire	applicants will fill health related quality of life SF-36 Questionnaire after PCNL or RIRS

Timeline

• Start date: 2021-01-01
• Primary completion: 2023-07-15
• Completion: 2023-08-01
• First posted: 2023-05-09
• Last updated: 2023-05-09

Locations

1 site across 1 country: Egypt