- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07310966
Comparison of Lithotomy Versus Lateral Position in Retrograde Intrarenal Surgery for Lower Calyceal Stones Less Than 2 cm
Comparison of Lithotomy Versus Lateral Position in Retrograde Intrarenal Surgery for Lower Calyceal Stones Less Than 2 cm: A Randomized Controlled Trial
Retrograde intrarenal surgery (RIRS) is an established minimally invasive treatment for renal stones, particularly for lower calyceal stones less than 2 cm, offering acceptable stone-free rates with low morbidity.
However, stone clearance in the lower calyx remains technically challenging due to unfavorable anatomy, limited scope deflection, and gravity-dependent fragment retention. Patient positioning during RIRS has been suggested as a modifiable factor that may influence endoscopic access, stone relocation, and surgical ergonomics.
The lithotomy position is conventionally used during RIRS, while the lateral position has been proposed to facilitate stone migration and improve lower calyceal access through gravitational assistance. Existing studies comparing patient positioning during RIRS are limited, with most evidence derived from retrospective analyses or non-randomized designs.
Therefore, this randomized controlled trial aims to compare lithotomy versus lateral positioning during RIRS for lower calyceal stones less than 2 cm in terms of operative and clinical outcomes.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Ammar Alorabi
- Phone Number: +201067608011
- Email: ammar.alorabi95@gmail.com
Study Locations
-
-
Menoufia
-
Shebin El-Kom, Menoufia, Egypt, 32511
- Menoufia Faculty of Medicine
-
Contact:
- Ammar Aziz
- Phone Number: +201097991198
- Email: ammar.alorabi95@gmail.com
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Adults aged ≥18 years.
- Single or multiple lower calyceal renal stones with stone size <2 cm confirmed by NCCT.
- Negative urine culture.
- Presented cases.
Exclusion Criteria:
- Multiple stones involving renal pelvis or other calyces.
- Anatomical anomalies affecting ureteroscope access (horseshoe kidney, malrotation, ureteral strictures).
- Pregnancy.
- Prior ipsilateral renal surgery.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Lithotomy position group
patients of this group undergo RIRS in Lithotomy position
|
Patients undergo RIRS in lithotomy position
|
|
Active Comparator: Lateral position group
patients of this group undergo RIRS in lateral position
|
Patients undergo RIRS in lateral position
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Stone Free Rate
Time Frame: 1 month
|
Stone-free rate (SFR), defined as no clinically significant residual stones on non-contrast 3-mm-cuts CT, measured as yes or no
|
1 month
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Operative time
Time Frame: The operative time
|
operative time is defined as time between starting the procedure and termination of it measured in minutes
|
The operative time
|
|
Complications
Time Frame: 1 month
|
Intra and postoperative complications, defined as complications happens intraoperative and postoperatively, graded by modified clavien-dindo classification
|
1 month
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
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
Additional Relevant MeSH Terms
- Urogenital Diseases
- Male Urogenital Diseases
- Calculi
- Pathological Conditions, Anatomical
- Kidney Diseases
- Urologic Diseases
- Female Urogenital Diseases
- Female Urogenital Diseases and Pregnancy Complications
- Urolithiasis
- Urinary Calculi
- Nephrolithiasis
- Pathological Conditions, Signs and Symptoms
- Kidney Calculi
Other Study ID Numbers
- Patient position in RIRS
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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