Determinants of Health-related Quality of Life for Patients After Renal Lithotripsy: PNL Versus RIRS
NCT ID: NCT05851339
Last Updated: 2023-05-09
Study Results
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Basic Information
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UNKNOWN
200 participants
OBSERVATIONAL
2021-01-01
2023-08-01
Brief Summary
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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
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Detailed Description
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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
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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PCNL
PCNL group applicants will answer SF-36 questionnaire
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
SF- 36 Questionnaire
applicants will fill health related quality of life SF-36 Questionnaire after PCNL or RIRS
Interventions
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SF- 36 Questionnaire
applicants will fill health related quality of life SF-36 Questionnaire after PCNL or RIRS
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
18 Years
70 Years
ALL
No
Sponsors
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South Valley University
OTHER
Responsible Party
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Mostafa AbdelRazek
Assistant Professor of Urology
Locations
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South Valley University
Qina, Qena Governorate, Egypt
Countries
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Other Identifiers
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SVU/MED/URO016/2.23.4.538
Identifier Type: -
Identifier Source: org_study_id
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