- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06879990
Retrograde Saline Irrigation During Supine Mini Percutaneous Nephrolithotomy
March 14, 2025 updated by: Elsayed Abdelhalim Elsayed, Kafrelsheikh University
The Role of Retrograde Saline Irrigation Through Double Lumen Ureteric Catheter During Supine Mini-percutanous Nephrolithotomy for Renal Stones Extraction:a Prospective Controlled Trial
This minimally invasive surgery allows us to remove kidney stones through tiny incisions and provides patients with quicker and smoother recoveries
Study Overview
Status
Completed
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
200
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
State
-
Kafr Ash Shaykh, State, Egypt, 44749
- Elsayed Abdelhalim
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- age above 18 years
- renal stones
Exclusion Criteria:
- age less than 18 years
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Supine mini percutaneous nephrolithotomy with irrigation
|
Retrograde normal saline irrigation during supine Mini percutaneous nephrolithotomy
|
|
Experimental: Supine mini percutaneous nephrolithotomy without irrigation
|
Without Retrograde normal saline irrigation during supine Mini percutaneous nephrolithotomy
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Stone free rate
Time Frame: two weeks from primary procedure
|
No stone residual fragments
|
two weeks from primary procedure
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Assess operative time
Time Frame: During procedure
|
Assess operative time in minutes
|
During procedure
|
|
Post operative complication
Time Frame: Up to 48 hours
|
Complication may occur post operative like fever , sever pain
|
Up to 48 hours
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 1, 2024
Primary Completion (Actual)
December 31, 2024
Study Completion (Actual)
December 31, 2024
Study Registration Dates
First Submitted
March 11, 2025
First Submitted That Met QC Criteria
March 11, 2025
First Posted (Actual)
March 25, 2025
Study Record Updates
Last Update Posted (Actual)
March 25, 2025
Last Update Submitted That Met QC Criteria
March 14, 2025
Last Verified
March 1, 2025
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 36264PR17/1/23
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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.