Kidney StoneNCT05852483
Predictors of Readmission in Patients Undergoing PNL
An observational study of Kidney Stone, run by Assiut University at 1 site in Egypt.
Trial summary
To identify predictors of patients postoperative readmission after PNL Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Kidney Stone
- How many people
- 161 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Apr 2022to 1 Dec 2022
- 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 65 years
- All sexes
- Adult, Older adult
Study population: adult male and female patients who had undergone PNL and their age range from)18-65(years in Assiut governorate
Who may be able to join
- Adult male and female patients
- patients shechedled for PNL
- age range from)18-65(years
Who cannot join
- Failed PNL
- psychiatric patients
- coagulopathy
- patients refused to participate in the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Perioperative Predictors of Postoperative Readmission Among Patients Undergoing Percutaneous Nephrolithotomy
To identify predictors of patients postoperative readmission after PNL
Read the detailed description
Percutaneous nephrolithotomy (PCNL) is a minimally-invasive procedure to remove stones from the kidney by a small puncture wound (up to about 1 cm) through the skin. It is usually done under general anesthesia or spinal anesthesia. Despite the advancements in endoscopic technologies technique and training, the procedure is still associated with complications, which can occur during the intervention or in the early or late postoperative period. Known complications to PCNL are fever (2.8-32.1%), bleeding requiring transfusion (0- 45%), organ injury (0-1.7%) and sepsis (0.3-1.5%) these complications consider life threatening and increase risk of patient readmission Readmission is defined as a state when the patient is admitted to the same or a different hospital after being discharged from the applicable hospital to a non-acute setting, such as his home within a specified time period . Hospital readmissions are frequent and costly, and are estimated to cost the US health care system > $12-17 billion annually . Readmissions occurring within the first week after discharge are often related to the stress of acute illness as well as heightened self-care needs, new medications, and impaired function while those occurring later reflect chronic illness Nurses could play a pivotal role in preventing readmissions through appropriate discharge teaching and following up with the patients after discharge through telephone conversations. Early identification of patients' problems and taking appropriate measures to handle these problems at an early stage helps to prevent further post-discharge complications and improves patient outcomes.
Nurse should emphasize to the patient the importance of reporting symptoms to physician immediately. Postoperative care should include: close monitoring of vital signs, close observation of urine output and color changes, wound care and careful observation for dressing and tube drainage.
Many studies have been found in the literature on readmissions after urological surgeries and their causes in recent years . These studies include general urological surgical procedures, and there are limited studies examining potential predictive factors for endourology and stone surgery
- Conditions
- Kidney Stone
- Keywords
- Predictors, Percutaneous nephrolithotomy, Readmission
- Medical subject headings
- Kidney Calculi
What is being measured
The primary outcome is the main question the study is designed to answer.
comparison between readmitted and non readmitted regarding readmission risk factors
analysis preioperative factors that lead to readmission after PNL
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 May 2023
- Study start1 Apr 2022
- Primary completion1 Oct 2022
- Study completion1 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Kidney StoneStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- 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
- 161 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hazem Tarraf Abo Dief, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05852483
- Sponsor's protocol ID
- Post PNL readmission
- Status last verified
- May 2023
- First submitted
- 2 May 2023
- Last updated
- 30 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Sharma K, Sankhwar SN, Goel A, Singh V, Sharma P, Garg Y. Factors predicting infectious complications following percutaneous nephrolithotomy. Urol Ann. 2016 Oct-Dec;8(4):434-438. doi: 10.4103/0974-7796.192105.
PubMed 28057987
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Perioperative Predictors of Postoperative Readmission Among Patients Undergoing Percutaneous Nephrolithotomy
- ClinicalTrials.gov ID
- NCT05852483
- Acronym / sponsor ID
- Post PNL readmission
- Conditions
- Kidney Stone
- Keywords
- Predictors, Percutaneous nephrolithotomy, Readmission
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 161 participants (actual)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Apr 2022 (actual)
- Primary completion
- 1 Oct 2022 (actual)
- Study completion
- 1 Dec 2022 (actual)
- First posted
- 10 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.
To identify predictors of patients postoperative readmission after PNL
Detailed description
Percutaneous nephrolithotomy (PCNL) is a minimally-invasive procedure to remove stones from the kidney by a small puncture wound (up to about 1 cm) through the skin. It is usually done under general anesthesia or spinal anesthesia. Despite the advancements in endoscopic technologies technique and training, the procedure is still associated with complications, which can occur during the intervention or in the early or late postoperative period. Known complications to PCNL are fever (2.8-32.1%), bleeding requiring transfusion (0- 45%), organ injury (0-1.7%) and sepsis (0.3-1.5%) these complications consider life threatening and increase risk of patient readmission Readmission is defined as a state when the patient is admitted to the same or a different hospital after being discharged from the applicable hospital to a non-acute setting, such as his home within a specified time period . Hospital readmissions are frequent and costly, and are estimated to cost the US health care system > $12-17 billion annually . Readmissions occurring within the first week after discharge are often related to the stress of acute illness as well as heightened self-care needs, new medications, and impaired function while those occurring later reflect chronic illness Nurses could play a pivotal role in preventing readmissions through appropriate discharge teaching and following up with the patients after discharge through telephone conversations. Early identification of patients' problems and taking appropriate measures to handle these problems at an early stage helps to prevent further post-discharge complications and improves patient outcomes.
Nurse should emphasize to the patient the importance of reporting symptoms to physician immediately. Postoperative care should include: close monitoring of vital signs, close observation of urine output and color changes, wound care and careful observation for dressing and tube drainage.
Many studies have been found in the literature on readmissions after urological surgeries and their causes in recent years . These studies include general urological surgical procedures, and there are limited studies examining potential predictive factors for endourology and stone surgery
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- adult male and female patients who had undergone PNL and their age range from)18-65(years in Assiut governorate
Key inclusion criteria (3 listed)
- Adult male and female patients
- patients shechedled for PNL
- age range from)18-65(years
Key exclusion criteria (4 listed)
- Failed PNL
- psychiatric patients
- coagulopathy
- patients refused to participate in the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
comparison between readmitted and non readmitted regarding readmission risk factors
Time frame: baseline
analysis preioperative factors that lead to readmission after PNL
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2025.
- Background: PubMed 28057987Sharma K, Sankhwar SN, Goel A, Singh V, Sharma P, Garg Y. Factors predicting infectious complications following percutaneous nephrolithotomy. Urol Ann. 2016 Oct-Dec;8(4):434-438. doi: 10.4103/0974-7796.192105.
- Members of the European Association of Urology (EAU) Guidelines Office. Guidelines on urolithiasis. 2019Link provided by the sponsor.
- 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 Kidney Stone, run by Assiut 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 3 inclusion and 4 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: finished, as of the sponsor's last update on 30 Jul 2025. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
comparison between readmitted and non readmitted regarding readmission risk factors (time frame: baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05852483, which also lists 1 linked publication.
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 30 Jul 2025.