Determinants of Health-related Quality of Life for Patients After Renal Lithotripsy: PNL Versus RIRS
- Conditions
- Health Related Quality of Life
- Interventions
- Other: SF- 36 Questionnaire
- Registration Number
- NCT05851339
- Lead Sponsor
- South Valley University
- Brief 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
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 200
- all patients performing PNL or RIRS for renal stones 2-4 cm
- Patients refuse to participate in this study Unfit patients Renal Stones more than 4 cm Renal Stones less than 2 cm
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description PCNL SF- 36 Questionnaire PCNL group applicants will answer SF-36 questionnaire RIRS SF- 36 Questionnaire RIRS group applicants will answer SF-36 questionnaire
- Primary Outcome Measures
Name Time Method Determinants of health-related quality of life for patients after renal lithotripsy: PCNL vs RIRS 2 years estimate quality of life patients after PCNL and after RIRS
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
South Valley University
🇪🇬Qinā, Qina, Egypt