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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04069013
Other study ID # 19-589
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date May 1, 2022
Est. completion date April 30, 2024

Study information

Verified date December 2023
Source The Cleveland Clinic
Contact Manoj Monga, MD
Phone 216-445-8678
Email mongam@ccf.org
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Randomized comparison of patient outcomes following standard PCNL versus mini-PCNL.


Description:

This study is a randomized controlled trial which compares the operative outcomes and complications of mini-percutaneous nephrolithotomy (mini-PCNL) versus standard PCNL for renal stones. This study will be a multi-institutional, prospective randomized controlled clinical trial with patients who have already agreed to undergo PCNL. Patients will be randomized at a 1:1 ratio to receive either standard PCNL or mini-PCNL, defined as tract sizes of 30 and 16.5 to 18 French respectively. Patients will be asked to complete pre-operative, and post-operative quality of life questionnaires, and to allow collection of one additional vial of blood for measurement of factors associated with inflammation. The participating institutions are academic medical centers in the United States and Canada that are part of the EDGE research consortium.


Recruitment information / eligibility

Status Recruiting
Enrollment 90
Est. completion date April 30, 2024
Est. primary completion date April 30, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Patients planned for PCNL at participating institutions - Age = 18 years old - Male and female patients - Patients of all ethnic backgrounds - Stone size 10-20mm Patients must be capable of giving informed consent and must be capable and willing to enroll and participate fully with the study. Exclusion Criteria: - Conversion to open procedure - Multiple access tracts - Anticoagulated or history of coagulopathy - Preoperative ureteral stent or nephrostomy tube placement - Technical problems/impossibility of localizing the stone on the day of intervention Patients unable to give informed consent or unwilling to enroll or participate in the study will be excluded.

Study Design


Intervention

Procedure:
PCNL
Patients receive standard of care treatment for their urolithiasis using one of two surgical procedures, either standard PCNL or Mini-PCNL

Locations

Country Name City State
United States Cleveland Clinic Foundation Cleveland Ohio

Sponsors (8)

Lead Sponsor Collaborator
The Cleveland Clinic Columbia University, Dartmouth-Hitchcock Medical Center, Duke University, Massachusetts General Hospital, Ohio State University, University of British Columbia, Vanderbilt University Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Blood loss as estimated by postoperative decreases in hemoglobin Blood loss as estimated by postoperative decreases in hemoglobin Blood Loss Blood loss as estimated by postoperative decreases in hemoglobin Blood loss as estimated by postoperative decreases in hemoglobin Blood loss as estimated by postoperative decreases in hemoglobin Blood loss as estimated by postoperative decreases in hemoglobin Post-op decreases in hemoglobin Post-operative day 1
Secondary Surgical outcomes Discharge time 30 Days
Secondary Complication Rates Complication Rates 30 Days
Secondary Renal Pelvis Pressures Intraoperative renal pelvis pressures Intraoperative
Secondary Procalcitonin- Inflammatory Markers Procalcitonin Post operative day 1
Secondary IL-6 Inflammatory Markers IL-6 Post operative day 1
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