The relationship between stone-free and patient position in retrograde intrarenal surgery: a randomized prospective study.
Cengiz Çanakcı, Erdinç Dinçer, Utku Can...
https://pubmed.ncbi.nlm.nih.gov/38722376Actively Recruiting
Phase Not Applicable
Age: 18Years +
All Genders
ID06809582
Does the Positioning in Retrograde Intrarenal Surgery Affect Stone-Free Rates? A Prospective Randomized Controlled Trial
Led by Ondokuz Mayıs University · Updated on 2025-08-15
128
Participants Needed
1
Research Sites
26 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating whether the surgical position during retrograde intrarenal surgery (RIRS) affects how completely kidney stones can be removed in adults. The study compares two positions: the standard lithotomy position and a modified lithotomy position called the T-Tilt position. This research aims to find out if the T-Tilt position results in higher stone-free rates and fewer complications after surgery. Participants will be randomly assigned to receive RIRS in either the standard lithotomy position or the T-Tilt position. The T-Tilt position involves placing the patient in a 30-degree head-down tilt (Trendelenburg) with the surgical side elevated at 30 degrees to help remove stone fragments more effectively. Both groups will undergo standard surgical procedures during the operation. Throughout the study, participants will have follow-up imaging 6 weeks after surgery to measure stone clearance. Researchers will also monitor complication rates within 30 days after surgery. The trial uses random assignment and triple blinding to compare outcomes and improve kidney stone treatment methods. The study starts in January 2025 and runs until June 2026.
CONDITIONS
Brief Title
Impact of Surgical Position on Stone-Free Rates in Retrograde Intrarenal Surgery
Who Can Participate
Age: 18Years +
All Genders
Eligibility Criteria
You may qualify if you...
- Presence of single or multiple kidney stones, with the largest stone 42 cm
- Age 18 years or older
- Provided written informed consent to participate in the study
- Indicated for retrograde intrarenal surgery (RIRS) as a treatment approach
You will not qualify if you...
- Severe cardiovascular disease such as heart failure
- Congenital kidney anomalies like horseshoe or ectopic kidney
- Having concurrent ureteral stones
- Pregnancy or planning pregnancy
- History of previous kidney surgery on the same side
- Active urinary tract infection
- Coagulopathy or use of anticoagulant therapy that cannot be stopped before surgery
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Surgery and Immediate Post-operative Care
Duration - 1 day
Participants undergo retrograde intrarenal surgery (RIRS) using either the standard lithotomy position or the T-Tilt lithotomy position to treat kidney stones. Immediate post-operative care follows the surgery to monitor recovery and complications.
1 surgical visit (in-person)
Post-operative Follow-up
Duration - Up to 6 weeks post-surgery
Participants are monitored for complications and recovery after surgery, including assessment of stone-free status.
1 follow-up visit at 6 weeks and additional visits as needed within 30 days post-surgery
Trial Site Locations
Total: 1 location
1
Ondokuz Mayıs University
Samsun, Turkey (Türkiye)
Actively Recruiting
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Research Team
M
Murat Gulsen
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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Published Research Related To This Trial
The T-Tilt Position: A Novel Modified Patient Position to Improve Stone-Free Rates in Retrograde Intrarenal Surgery.
Christine W Liaw, Johnathan A Khusid, Blair Gallante...
https://pubmed.ncbi.nlm.nih.gov/34251886