Open Renal SurgeryNCT07097883
Impact of Previous Open Renal Surgery on Percutaneous Nephrolithotomy Complications
An observational study of Open Renal Surgery and Percutaneous Nephrolithotomy, run by Sohag University at 1 site in Egypt.
Trial summary
This study compared percutaneous nephrolithotomy (PCNL) complications in cases with or without previous renal surgery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Open Renal Surgery, Percutaneous Nephrolithotomy, Complications
- What is being tested?
- Percutaneous Nephrolithotomy
- Type of treatment
- Surgery or procedure
- How many people
- 200 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jan 2017to 1 Aug 2020
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: This prospective hospital-based comparative study included 200 patients with recurrent renal stones in one arm and an equal number of patients in a control arm.
Who may be able to join
- Adult patients (≥18 years).
- Both sexes.
- Undergoing percutaneous nephrolithotomy (PCNL) for renal calculi >2 cm.
Who cannot join
- Active urinary tract infection.
- Elevated serum creatinine >2.0 mg/dL.
- Pregnancy.
- Uncontrolled coagulopathy.
- Significant cardiopulmonary comorbidities.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Impact of Previous Open Renal Surgery on Percutaneous Nephrolithotomy Complications
This study compared percutaneous nephrolithotomy (PCNL) complications in cases with or without previous renal surgery.
Read the 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.
- Being tested
- Percutaneous Nephrolithotomy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Percutaneous NephrolithotomyProcedure or surgery
Patients underwent percutaneous nephrolithotomy (PCNL) for renal calculi >2 cm.
| Study group | Role | What they receive |
|---|---|---|
| Fresh cases | Patients with no prior renal surgery. Receives: Procedure: Percutaneous Nephrolithotomy | |
| Recurrent cases | Patients with previous open renal surgery on the same side. Receives: Procedure: Percutaneous Nephrolithotomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hospital stay duration
Lenght of hospital stay was recorded from the admission till the discharge from hospital.
Measured: Till the discharge from hospital (Up to two weeks)
Secondary outcomes (2)
Serum creatinine level
Serum creatinine level was recorded.
Measured: Preoperatively
Incidence of patients who need for auxiliary procedure
Incidence of patients who need for auxiliary procedure were recorded.
Measured: 24 hours postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2025
- Study start1 Jan 2017
- Primary completion1 Aug 2020
- Study completion1 Aug 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Open Renal SurgeryStudies of the same condition, open and under way.
- More trials run by Sohag 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
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Mahmoud Reyad, Sohag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07097883
- Sponsor's protocol ID
- Soh-Med-25-6-1PD
- Status last verified
- Jul 2025
- First submitted
- 24 Jul 2025
- Last updated
- 31 Jul 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Previous Open Renal Surgery on Percutaneous Nephrolithotomy Complications
- ClinicalTrials.gov ID
- NCT07097883
- Acronym / sponsor ID
- Soh-Med-25-6-1PD
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- 1 Jan 2017 (actual)
- Primary completion
- 1 Aug 2020 (actual)
- Study completion
- 1 Aug 2020 (actual)
- First posted
- 31 Jul 2025 (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.
This study compared percutaneous nephrolithotomy (PCNL) complications in cases with or without previous renal surgery.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fresh cases | – | Procedure: Percutaneous NephrolithotomyPatients with no prior renal surgery. |
| Recurrent cases | – | Procedure: Percutaneous NephrolithotomyPatients with previous open renal surgery on the same side. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- This prospective hospital-based comparative study included 200 patients with recurrent renal stones in one arm and an equal number of patients in a control arm.
Key inclusion criteria (3 listed)
- Adult patients (≥18 years).
- Both sexes.
- Undergoing percutaneous nephrolithotomy (PCNL) for renal calculi >2 cm.
Key exclusion criteria (5 listed)
- Active urinary tract infection.
- Elevated serum creatinine >2.0 mg/dL.
- Pregnancy.
- Uncontrolled coagulopathy.
- Significant cardiopulmonary comorbidities.
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 |
|---|---|---|
| Percutaneous NephrolithotomyPatients underwent percutaneous nephrolithotomy (PCNL) for renal calculi >2 cm. | Procedure or surgery | Fresh cases, Recurrent cases |
Primary outcome
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.
2 secondary outcomes
Serum creatinine level
Time frame: Preoperatively
Incidence of patients who need for auxiliary procedure
Time frame: 24 hours postoperatively
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 31 Jul 2025.
- Individual participant dataSharing planned: Yes. The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
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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 Open Renal Surgery and Percutaneous Nephrolithotomy, run by Sohag 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 5 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 31 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?
Hospital stay duration (time frame: Till the discharge from hospital (Up to two weeks)). 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 31 Jul 2025.