An interventional study of Combined Intrarenal Surgery and percutaneous nephrolithotomy in Urinary Calculi, sponsored by Al-Azhar University. Recruiting at 1 site in Egypt. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2024-07-25.
Sponsored by Al-Azhar University · Not applicable, Interventional, and Treatment
This is a prospective randomized study to compare endoscopic combined intrarenal surgery and PCNL as modalities of treatment for staghorn stones. In terms of efficacy and safety
This is a prospective randomized study to compare endoscopic combined intrarenal surgery and PCNL as modalities of treatment for staghorn stones. In terms of efficacy and safety The efficacy will be studied at stone-free rate While efficacy will be studied using DMSA scan pre- and post-procedures in addition to the safety of each procedure with regard to intra- and post-operative complications,.
94 studies on the registry are indexed under Urinary Calculi; 20 are open to participants now.
This study's planned enrollment of 100 is below the median of 120 across 61 interventional studies indexed under Urinary Calculi.
Browse Urinary Calculi studies →Al-Azhar University is the lead sponsor of 531 studies on the registry; 172 are open to participants now.
Of its 5 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
50 patients will undergo percutaneous nephrolithotomy (PCNL).
Procedure: Combined Intrarenal Surgery and percutaneous nephrolithotomy
50 patients will undergo endoscopic combined intrarenal surgery (ECIRS).
Procedure: Combined Intrarenal Surgery and percutaneous nephrolithotomy
A study was conducted to compare endoscopic combined intrarenal surgery and percutaneous nephrolithotomy as modalities of treatment for staghorn stones.
stone-free rate
Stone-free is defined as no residual stones on CT-UT or clinically insignificant residual fragments (CIRF) less than 4 mm in diameter. It will be measured twice, first immediately postoperatively, and then again after 3 months of the procedure.
Time frame: 3 months postoperative
Safety of the procedure
Intra and post-operative complications
Time frame: intraoperative, early (in the first day postoperative) and late complications (3 months after the surgery).
Plan to share: No
No publications or documents are linked to this record.
Started Jul 2023 (actual). Primary completion is estimated for Dec 2024, 17 months after the start.
Of 31 interventional studies with no phase under Urinary Calculi, half reached primary completion within 74 months of starting (the median), counting those still running; a quarter within 20 and three quarters within 79. This study's planned 17 months is below that.
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