The Use of the "Comprehensive Complication Index" for Urinary Lithiasis Surgery.

The Use of the "Comprehensive Complication Index" as a Recording System of Postoperative Complications After Percutaneous, Retrograde and Extracorporeal Lithotripsy for Renal Lithiasis.

The study will be prospective non-interventional and will include patients with kidney stones who are to undergo one of the following three techniques: retrograde nephrolithotripsy, percutaneous nephrolithotripsy and extracorporeal nephrolithotripsy depending on the size of the stone. Data regarding post operative descriptions will be recorded and comprehensive complication index will be used for the assesment of the burden.

Study Overview

• Status: Recruiting
• Conditions: Complication,Postoperative; Lithiasis, Urinary
• Intervention / Treatment: Procedure: lithotripsy

Detailed Description

The study will be prospective non-interventional and will include patients with kidney stones who are to undergo one of the following three techniques: retrograde nephrolithotripsy, percutaneous nephrolithotripsy and extracorporeal nephrolithotripsy depending on the size of the stone. The study will take place at the 2nd Urology Clinic of the University of Athens, at the Sismanoglio Hospital of Athens. It will include patients diagnosed with kidney stones after plain X-ray and/or CT scan. Percutaneous nephrolithotripsy will be performed on stones > 2 cm, while extracorporeal or retrograde nephrolithotripsy on stones < 2 cm. Patient demographics (age, gender, body mass index, comorbidities, anticoagulant use), stone-related data (maximum stone size, anatomic location of stone, number of stones, presence of hydronephrosis preoperatively, presence of piglet catheter preoperatively, positive urine culture, preoperative chemoprophylaxis ) as well as information about the operation (type of anesthesia, operation time, hospitalization time) will be reported. Finally, all possible complications will be recorded intraoperatively, immediately postoperatively and up to 30 days after the day of surgery. This will be followed by a statistical analysis of the resulting data and a comparison between the CDC and CCI systems using the SPSS statistical program. To describe continuous variables, the mean/standard deviation will be used if it is a normal distribution, or the median and range if it is a non-normal distribution. The Shapiro-Wilk test will be used to investigate the distribution of the data. The absolute number and the corresponding percentage will be used to describe the qualitative variables. For the comparison of continuous variables, the parametric t-test will be used if the data follow a normal distribution, or the Mann-Whitney U test if they do not follow a normal distribution. Chi-square and Fisher's exact test will be used to compare qualitative variables. Exclusion criteria from this study are:

1. Non-acceptance by the patient of his participation or inability to understand the purposes and procedures of the study.
2. Recent similar operation that the patient has undergone (interval of less than one month).

• Study Type: Observational
• Enrollment (Anticipated): 400

Contacts and Locations

• Study Contact: Name: Charalambos M Deliveliotos, MD; Phone Number: 23102058369; Email: ourologiki@sismanoglio.gr

Study Locations

• Greece
  • Marousi
    • Athens, Marousi, Greece, 15126
      • Recruiting
      • Sismanoglio General Hospital
      • Contact: Charalambos Deliveliotis; Phone Number: 2132058; Email: ourologiki@sismanoglio.gr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

patients with lithiasis

Description

Inclusion Criteria:

Patients with urinary lithiasis undergoing ureterolithotripsy, percutaneous nephrolithotripsy or extracorporeal shockwave lithotripsy.

Exclusion Criteria:

- 1. Non-acceptance by the patient of his participation or inability to understand the purposes and procedures of the study.

2. Recent similar operation that the patient has undergone (interval of less than one month).

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
patients with lithiasis treated with ureterolithotripsy	Procedure: lithotripsy; lithotripsy; Other Names: percutaneous nephrolithotomy; extracorporeal shockwave lithotripsy
patients with lithiasis treated with percutaneous nephrolithotomy	Procedure: lithotripsy; lithotripsy; Other Names: percutaneous nephrolithotomy; extracorporeal shockwave lithotripsy
patients with lithiasis treated with extracorporeal shockwave lithotripsy	Procedure: lithotripsy; lithotripsy; Other Names: percutaneous nephrolithotomy; extracorporeal shockwave lithotripsy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
comprehensive complication index score	reporting postoperative complications with clavien dindo and comprehensive complication index and comparison of those two.	1,5 year

Collaborators and Investigators

• Sponsor: Sismanoglio General Hospital

Study record dates

Study Major Dates

• Study Start (Actual): October 21, 2022
• Primary Completion (Anticipated): June 30, 2024
• Study Completion (Anticipated): June 30, 2024

Study Registration Dates

• First Submitted: October 21, 2022
• First Submitted That Met QC Criteria: October 21, 2022
• First Posted (Actual): October 25, 2022

Study Record Updates

• Last Update Posted (Actual): October 25, 2022
• Last Update Submitted That Met QC Criteria: October 21, 2022
• Last Verified: October 1, 2022

More Information

Terms related to this study

• Keywords: complications; clavien dindo; urinary lithiasis; endourology
• Additional Relevant MeSH Terms: Pathologic Processes; Urologic Diseases; Pathological Conditions, Anatomical; Calculi; Postoperative Complications; Urinary Calculi; Urolithiasis; Lithiasis
• Other Study ID Numbers: 67127

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No