Health Related Quality of LifeNCT05851339
Determinants of Health-related Quality of Life for Patients After Renal Lithotripsy: PNL Versus RIRS
An observational study of Health Related Quality of Life, run by South Valley University at 1 site in Egypt.
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… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Health Related Quality of Life
- What is being tested?
- SF- 36 Questionnaire
- How many people
- 200 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jan 2021to 1 Aug 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- Adult, Older adult
Study population: all patients presented to our clinics will performing PCNL or RIRS 100 patents in each group
Who may be able to join
- all patients performing PNL or RIRS for renal stones 2-4 cm
Who cannot join
- Patients refuse to participate in this study Unfit patients Renal Stones more than 4 cm Renal Stones less than 2 cm
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Determinants of Health-related Quality of Life for Patients After Renal Lithotripsy: Percutaneous Nephrolithotomy (PCNL) Versus Retrograde Intrarenal Surgery(RIRS)
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.
Read more
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
Read the 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:
- 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
- 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
- Abdominal U.S
- Plain X Ray
- Non contrast CT
- Serum Creatinine
- Urine Analysis
- Conditions
- Health Related Quality of Life
- Being tested
- SF- 36 Questionnaire
- Keywords
- quality of life , PCNL , RIRS
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SF- 36 QuestionnaireOther
applicants will fill health related quality of life SF-36 Questionnaire after PCNL or RIRS
| Study group | Role | What they receive |
|---|---|---|
| PCNL | PCNL group applicants will answer SF-36 questionnaire Receives: Other: SF- 36 Questionnaire | |
| RIRS | RIRS group applicants will answer SF-36 questionnaire Receives: Other: SF- 36 Questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2023
- Study start1 Jan 2021
- Primary completion15 Jul 2023 (estimated)
- Study completion1 Aug 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Health Related Quality of LifeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- South Valley University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mostafa AbdelRazek, South Valley University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05851339
- Sponsor's protocol ID
- SVU/MED/URO016/2.23.4.538
- Status last verified
- May 2023
- First submitted
- 1 May 2023
- Last updated
- 9 May 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Determinants of Health-related Quality of Life for Patients After Renal Lithotripsy: Percutaneous Nephrolithotomy (PCNL) Versus Retrograde Intrarenal Surgery(RIRS)
- ClinicalTrials.gov ID
- NCT05851339
- Acronym / sponsor ID
- SVU/MED/URO016/2.23.4.538
- Conditions
- Health Related Quality of Life
- Keywords
- quality of life , PCNL , RIRS
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- South Valley UniversityUniversity, hospital or other
- Study start
- 1 Jan 2021 (actual)
- Primary completion
- 15 Jul 2023 (estimated)
- Study completion
- 1 Aug 2023 (estimated)
- First posted
- 9 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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
- 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
- Abdominal U.S
- Plain X Ray
- Non contrast CT
- Serum Creatinine
- Urine Analysis
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PCNL | – | Other: SF- 36 QuestionnairePCNL group applicants will answer SF-36 questionnaire |
| RIRS | – | Other: SF- 36 QuestionnaireRIRS group applicants will answer SF-36 questionnaire |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- all patients presented to our clinics will performing PCNL or RIRS 100 patents in each group
Key inclusion criteria (1 listed)
- all patients performing PNL or RIRS for renal stones 2-4 cm
Key exclusion criteria (1 listed)
- Patients refuse to participate in this study Unfit patients Renal Stones more than 4 cm Renal Stones less than 2 cm
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SF- 36 Questionnaireapplicants will fill health related quality of life SF-36 Questionnaire after PCNL or RIRS | Other | PCNL, RIRS |
Primary outcome
Determinants of health-related quality of life for patients after renal lithotripsy: PCNL vs RIRS
Time frame: 2 years
estimate quality of life patients after PCNL and after RIRS
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 May 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Health Related Quality of Life, run by South Valley University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Determinants of health-related quality of life for patients after renal lithotripsy: PCNL vs RIRS (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 May 2023.