Clinical trial NCT05851339: Determinants of Health-related Quality of Life for Patients After Renal Lithotripsy: PNL Versus RIRS
Official title: Determinants of Health-related Quality of Life for Patients After Renal Lithotripsy: Percutaneous Nephrolithotomy (PCNL) Versus Retrograde Intrarenal Surgery(RIRS)
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Health Related Quality of Life
Keywords: quality of life , PCNL , RIRS
Lead sponsor: South Valley University
Sponsor class: OTHER
First posted: 2023-05-09
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: all patients presented to our clinics will performing PCNL or RIRS 100 patents in each group

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

Eligibility criteria: 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

Primary outcomes:
measure: Determinants of health-related quality of life for patients after renal lithotripsy: PCNL vs RIRS
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Qinā
country: Egypt
facility: South Valley University
state: Qina
Study officials:
References: