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)

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05851339
• Other study ID #: SVU/MED/URO016/2.23.4.538
• Status: Active, not recruiting
• Start date: January 1, 2021
• Est. completion date: August 1, 2023

Study information

• Verified date: May 2023
• Source: South Valley University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

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

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 information / eligibility

• Status: Active, not recruiting
• Enrollment: 200
• Est. completion date: August 1, 2023
• Est. primary completion date: July 15, 2023
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Health Related Quality of Life

Intervention

Other:
• SF- 36 Questionnaire
applicants will fill health related quality of life SF-36 Questionnaire after PCNL or RIRS

Locations

Country	Name	City	State
Egypt	South Valley University	Qina	Qina

Sponsors (1)

Lead Sponsor	Collaborator
South Valley University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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