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

South Valley University

Status: Active, not recruiting

Conditions: Health Related Quality of Life

Treatments: Other: SF- 36 Questionnaire

Study type: Observational

Funder types: Other

Identifiers

NCT05851339

SVU/MED/URO016/2.23.4.538

Details and patient eligibility

About

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

Full 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

Enrollment: 200 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

200 participants in 2 patient groups

PCNL

Description:

PCNL group applicants will answer SF-36 questionnaire

Treatment:

Other: SF- 36 Questionnaire

RIRS

Description:

RIRS group applicants will answer SF-36 questionnaire

Treatment:

Other: SF- 36 Questionnaire