Assessment of Flexible Ureteroscopy Residual Fragments

NCT02434068 | Unknown

• 1 other identifier: 11851
• Study Type: observational
• Target: 115
• Locations: 1 country
• Sites: 1

Brief Summary

Residual fragments of urinary calculi after flexible ureteroscopy (URF) can cause symptoms and additional surgeries. The assessment of residual fragments by imaging is not standardized. Computed tomography (CT) is the best way for evaluation of urinary stones, however, ionizing radiation from CT is deleterious. The aim of this study is to define which patients may avoid CT for evaluation of residual fragments after URF. 115 patients with \> 18 years old undergoing URF for kidney stone \< 20 mm or \< 15 mm in the lower calyx diagnosed by CT will be studied. The clinical evaluation of patients will be held by the same urologist in pre-operative consultation, 7 days after the procedure, 30 days after the procedure and 100 days after the procedure. The assessment of residual fragments will be made through TC, ultrasound and Kidney-bladder-ureter KUB 90 days after the procedure. The image methods for residual fragments assessment will be compared by Cochran Test and prediction of parameters to avoid CT will be made by multiple logistic regression, using IPSS 16.0, with significant level of 5%.

Conditions

Kidney Calculi

Keywords

kidney calculi; followup studies

Outcome Measures

Primary Outcomes (1)

• residual calculi > 2mm by CT

  90 days

Secondary Outcomes (1)

• complications by CT

  90 days

Study Arms (1)

stone residuals

all patients are going to be submitted to the same intervention: CT, US, KUB

Other: CT

Interventions

CT OTHER

followup

Also known as: US, KUB

stone residuals

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with symptomatic renal calculi

You may qualify if:

• Kidney calculi \> 5 mm and \< 20 mm or \< 15 mm in lower kidney calyx

You may not qualify if:

• Patients with kidney malformations, ureteral stenosis, previous ipsilateral kidney surgery, hydronephrosis, indwelling double J stent and contraindications for URF are going to be excluded.

Sponsors & Collaborators

• University of Sao Paulo General Hospital: lead
• Fundação de Amparo à Pesquisa do Estado de São Paulo: collaborator

Study Sites (1)

University of Sao Paulo General Hospital

São Paulo, São Paulo, Brazil

Location

MeSH Terms

Conditions

Kidney Calculi

Condition Hierarchy (Ancestors)

Nephrolithiasis; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urolithiasis; Urinary Calculi; Male Urogenital Diseases; Calculi; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Officials

• Alexandre Danilovic, MD

  University of Sao Paulo General Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 19, 2015
• First Posted: May 5, 2015
• Study Start: March 1, 2015
• Primary Completion: March 1, 2017
• Study Completion: July 1, 2017
• Last Updated: October 28, 2016

Record last verified: 2016-10

Locations

BR (1)