Search
Close this search box.

Clinical Outcomes of Percutaneous Nephrolithotomy Following Retrograde Percutaneous Nephrostomy Access Using Novel Device in Comparison to Antegrade Access

Studies

Study First Submitted Date 2021-08-19
Study First Posted Date 2021-08-26
Last Update Posted Date 2023-05-10
Start Month Year January 2024
Primary Completion Month Year September 2024
Verification Month Year May 2023
Verification Date 2023-05-31
Last Update Posted Date 2023-05-10

Facilities

Sequence: 201200491
Name The University of Texas Health Science Center at Houston
City Houston
State Texas
Zip 77030
Country United States

Facility Contacts

Sequence: 28268275 Sequence: 28268276
Facility Id 201200491 Facility Id 201200491
Contact Type primary Contact Type backup
Name Nadeem N Dhanani, MD,MPH Name Amy Isidahomen
Email Nadeem.N.Dhanani@uth.tmc.edu Email Amy.Isidahomen@uth.tmc.edu
Phone 713-500-7337 Phone 713-500-6086

Conditions

Sequence: 52479470
Name Kidney Stone
Downcase Name kidney stone

Id Information

Sequence: 40379323
Id Source org_study_id
Id Value HSC-MS-20-1269

Countries

Sequence: 42815014
Name United States
Removed False

Design Groups

Sequence: 55935539 Sequence: 55935540
Group Type Experimental Group Type Active Comparator
Title Treatment (retrograde nephrostomy) Title Control Group ( antegrade nephrostomy)

Interventions

Sequence: 52789237 Sequence: 52789238
Intervention Type Device Intervention Type Device
Name retrograde nephrostomy Name antegrade nephrostomy
Description this will consist of one visit to a urologist for retrograde nephrostomy placement using a Retroperc device with lithotomy performed in the same visit and follow up at 4 weeks and 6 months. Description this will consist of two visits, first to the interventional radiologist for antegrade nephrostomy placement followed by another visit to the urologist for lithotomy with follow up at 4 weeks and 6 months

Keywords

Sequence: 80287295
Name nephrostomy
Downcase Name nephrostomy

Design Outcomes

Sequence: 178535626 Sequence: 178535614 Sequence: 178535615 Sequence: 178535616 Sequence: 178535617 Sequence: 178535618 Sequence: 178535619 Sequence: 178535620 Sequence: 178535621 Sequence: 178535622 Sequence: 178535623 Sequence: 178535624 Sequence: 178535625 Sequence: 178535627 Sequence: 178535628 Sequence: 178535629
Outcome Type secondary Outcome Type primary Outcome Type primary Outcome Type primary Outcome Type primary Outcome Type primary Outcome Type primary Outcome Type primary Outcome Type primary Outcome Type primary Outcome Type primary Outcome Type primary Outcome Type secondary Outcome Type secondary Outcome Type secondary Outcome Type secondary
Measure Number of patients with normal vital signs Measure Treatment efficacy as measured by the time taken from diagnosis to nephrostomy access Measure Treatment efficacy as measured by total time of access operation. Measure Treatment efficacy as measured by total time of access operation fluoroscopy Measure Treatment efficacy as measured by total time of lithotomy operation Measure Treatment efficacy as measured by total time of lithotomy operation fluoroscopy Measure Treatment efficacy as measured by length of post-operative hospital stay Measure Number of patients that are stone free Measure Number of patients with symptom free survival as defined as lack of flank pain Measure Number of patients with symptom free survival as defined as lack of presence of urinary or gastrointestinal symptoms, Measure Number of patients with symptom free survival as defined as lack of limitations to work Measure Number of patients with symptom free survival as defined as lack of limitations to social or daily activities. Measure Number of patients with nephrostomy access adequate for stone treatment Measure Number of patients with normal laboratory values Measure Number of patients with an infection rate which is defined as a positive culture within the study time period Measure Number of patients that require pain medication (defined as discharge with an opioid prescription).
Time Frame end of procedure( abut 3 hours from start of procedure) Time Frame end of procedure (about 4-8 weeks from diagnosis) Time Frame end of procedure( about 90 minutes after start of procedure) Time Frame end of procedure( about 90 minutes after start of procedure) Time Frame end of procedure(about 3 hours after start of procedure) Time Frame (end of procedure)about 3 hours after start of procedure Time Frame 24 hours after procedure Time Frame 6-12 weeks after procedure Time Frame 6-12 weeks after procedure Time Frame 6-12 weeks after procedure Time Frame 6-12 weeks after procedure Time Frame 6-12 weeks after procedure Time Frame end of procedure( abut 3 hours from start of procedure) Time Frame 24 hours after procedure Time Frame 6-12 weeks after procedure Time Frame 6-12 weeks after procedure
Description stone free is defined as <2mm on non-contrast computed tomography Description laboratory values include complete metabolic panel and urinalysis

Browse Conditions

Sequence: 194664416 Sequence: 194664417 Sequence: 194664418 Sequence: 194664419 Sequence: 194664420 Sequence: 194664421 Sequence: 194664422 Sequence: 194664423 Sequence: 194664424 Sequence: 194664425 Sequence: 194664426 Sequence: 194664427
Mesh Term Kidney Calculi Mesh Term Nephrolithiasis Mesh Term Kidney Diseases Mesh Term Urologic Diseases Mesh Term Female Urogenital Diseases Mesh Term Female Urogenital Diseases and Pregnancy Complications Mesh Term Urogenital Diseases Mesh Term Urolithiasis Mesh Term Urinary Calculi Mesh Term Male Urogenital Diseases Mesh Term Calculi Mesh Term Pathological Conditions, Anatomical
Downcase Mesh Term kidney calculi Downcase Mesh Term nephrolithiasis Downcase Mesh Term kidney diseases Downcase Mesh Term urologic diseases Downcase Mesh Term female urogenital diseases Downcase Mesh Term female urogenital diseases and pregnancy complications Downcase Mesh Term urogenital diseases Downcase Mesh Term urolithiasis Downcase Mesh Term urinary calculi Downcase Mesh Term male urogenital diseases Downcase Mesh Term calculi Downcase Mesh Term pathological conditions, anatomical
Mesh Type mesh-list Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor

Sponsors

Sequence: 48605753
Agency Class OTHER
Lead Or Collaborator lead
Name The University of Texas Health Science Center, Houston

Overall Officials

Sequence: 29446962
Role Principal Investigator
Name Nadeem N Dhanani, MD,MPH
Affiliation The University of Texas Health Science Center, Houston

Central Contacts

Sequence: 12087988 Sequence: 12087989
Contact Type primary Contact Type backup
Name Nadeem N Dhanani, MD,MPH Name Amy Isidahomen
Phone (713) 500-7337 Phone 713-500-6086
Email Nadeem.N.Dhanani@uth.tmc.edu Email Amy.Isidahomen@uth.tmc.edu
Role Contact Role Contact

Design Group Interventions

Sequence: 68571386 Sequence: 68571387
Design Group Id 55935539 Design Group Id 55935540
Intervention Id 52789237 Intervention Id 52789238

Eligibilities

Sequence: 30942210
Gender All
Minimum Age N/A
Maximum Age N/A
Healthy Volunteers No
Criteria Inclusion Criteria: -Renal pelvis and proximal ureteral stones >10 mm confirmed with non-contrast computed tomography Exclusion Criteria: Suspected pyelonephritis. Prior percutaneous nephrolithotomy procedure in affected kidney. Mid-ureteral or distal ureteral stones. Pregnancy. Anatomical abnormal kidney, including: Horseshoe Ectopic
Adult True
Child True
Older Adult True

Calculated Values

Sequence: 254282727
Number Of Facilities 1
Registered In Calendar Year 2021
Were Results Reported False
Has Us Facility True
Has Single Facility True
Number Of Primary Outcomes To Measure 11
Number Of Secondary Outcomes To Measure 5

Designs

Sequence: 30687820
Allocation Randomized
Intervention Model Parallel Assignment
Observational Model
Primary Purpose Treatment
Time Perspective
Masking None (Open Label)

Responsible Parties

Sequence: 29054557
Responsible Party Type Principal Investigator
Name Nadeem N Dhanani
Title Assistant Professor
Affiliation The University of Texas Health Science Center, Houston