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

Study Overview
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Brief Summary
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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
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2.4.1- Type of the study: prospective randomized clinical study 2.4. 2- Study Setting: Qena University Hospital 2.4. 3- Study subjects: 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 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 Abdominal U.S Plain X Ray Non contrast CT Serum Creatinine Urine Analysis

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

Conditions
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Health Related Quality of Life

Intervention / Treatment
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* Other: SF- 36 Questionnaire


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| PCNL<br>PCNL group applicants will answer SF-36 questionnaire | Other: SF- 36 Questionnaire<br>* applicants will fill health related quality of life SF-36 Questionnaire after PCNL or RIRS<br>|
| RIRS<br>RIRS group applicants will answer SF-36 questionnaire | Other: SF- 36 Questionnaire<br>* applicants will fill health related quality of life SF-36 Questionnaire after PCNL or RIRS<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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quality of life , PCNL , RIRS