- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07097883
- Original Trial
Impact of Previous Open Renal Surgery on Percutaneous Nephrolithotomy Complications
The Impact of Previous Open Renal Surgery on Percutaneous Nephrolithotomy Complications
Study Overview
Status
Intervention / Treatment
Detailed Description
Percutaneous nephrolithotomy (PCNL) is a cornerstone in managing large renal calculi. However, in patients with a history of previous open renal surgery (POS), retroperitoneal scarring, altered anatomy, and vascular complications may influence PCNL outcomes.
The literature remains inconsistent regarding whether POS negatively impacts PCNL success or increases complications. Therefore, this study aims to clarify the comparative safety and efficacy of PCNL in patients with and without prior open renal surgery.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
-
Sohag, Egypt, 82511
- Sohag University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Adult patients (≥18 years).
- Both sexes.
- Undergoing percutaneous nephrolithotomy (PCNL) for renal calculi >2 cm.
Exclusion Criteria:
- Active urinary tract infection.
- Elevated serum creatinine >2.0 mg/dL.
- Pregnancy.
- Uncontrolled coagulopathy.
- Significant cardiopulmonary comorbidities.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Fresh cases
Patients with no prior renal surgery.
|
Patients underwent percutaneous nephrolithotomy (PCNL) for renal calculi >2 cm.
|
|
Recurrent cases
Patients with previous open renal surgery on the same side.
|
Patients underwent percutaneous nephrolithotomy (PCNL) for renal calculi >2 cm.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Hospital stay duration
Time Frame: Till the discharge from hospital (Up to two weeks)
|
Lenght of hospital stay was recorded from the admission till the discharge from hospital.
|
Till the discharge from hospital (Up to two weeks)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Serum creatinine level
Time Frame: Preoperatively
|
Serum creatinine level was recorded.
|
Preoperatively
|
|
Incidence of patients who need for auxiliary procedure
Time Frame: 24 hours postoperatively
|
Incidence of patients who need for auxiliary procedure were recorded.
|
24 hours postoperatively
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- Soh-Med-25-6-1PD
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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