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

NCT05593783 | Unknown

• 1 other identifier: 67127
• Study Type: observational
• Target: 400
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Complication,Postoperative; Lithiasis, Urinary

Keywords

clavien dindo; urinary lithiasis; endourology; complications

Outcome Measures

Primary Outcomes (1)

• comprehensive complication index score

  reporting postoperative complications with clavien dindo and comprehensive complication index and comparison of those two.

  1,5 year

Study Arms (3)

patients with lithiasis treated with ureterolithotripsy

patients with lithiasis treated with ureterolithotripsy

Procedure: lithotripsy

patients with lithiasis treated with percutaneous nephrolithotomy

patients with lithiasis treated with percutaneous nephrolithotomy

Procedure: lithotripsy

patients with lithiasis treated with extracorporeal shockwave lithotripsy

patients with lithiasis treated with extracorporeal shockwave lithotripsy

Procedure: lithotripsy

Interventions

lithotripsy PROCEDURE

lithotripsy

Also known as: percutaneous nephrolithotomy, extracorporeal shockwave lithotripsy

patients with lithiasis treated with extracorporeal shockwave lithotripsy; patients with lithiasis treated with percutaneous nephrolithotomy; patients with lithiasis treated with ureterolithotripsy

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

patients with lithiasis

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Sismanoglio General Hospital: lead

Study Sites (1)

Sismanoglio General Hospital

Athens, Marousi, 15126, Greece

RECRUITING

MeSH Terms

Conditions

Postoperative Complications; Urolithiasis

Interventions

Lithotripsy; Nephrolithotomy, Percutaneous

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Therapeutics; Ultrasonic Surgical Procedures; Surgical Procedures, Operative; Laparoscopy; Endoscopy; Minimally Invasive Surgical Procedures; Urologic Surgical Procedures; Urogenital Surgical Procedures

Central Study Contacts

Charalambos M Deliveliotos, MD

CONTACT

23102058369; ourologiki@sismanoglio.gr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr Stamatios Katsimperis

Study Record Dates

• First Submitted: October 21, 2022
• First Posted: October 25, 2022
• Study Start: October 21, 2022
• Primary Completion: June 30, 2024
• Study Completion: June 30, 2024
• Last Updated: October 25, 2022

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will not share

Locations

GR (1)