Prospective Versus Retrospective Complications in Radical Cystectomy and Nephrectomy

NCT03052504 | Completed DMC

• 1 other identifier: CSA-1
• Study Type: observational
• Target: 156
• Locations: 1 country
• Sites: 1

Brief Summary

The study will examine which differences there are in comorbidity and complications collected retrospectively from medical records compared with data collected prospectively in two groups of patients undergoing either radical cystectomy or radical nephrectomy. Hypothesis is that he prevalence of registered comorbidity and minor complications in patients who have undergone radical cystectomy or nephrectomy, will increase if the data collection is focused and prospective, compared with retrospectively collected data. The study will be conducted as a single-blind randomized controlled trial. Patients included in the study will be randomized to either control or intervention in the ratio 1:1. There are two groups of patients: Patients admitted to radical cystectomy and patients admitted to radical nephrectomy, due to cancer.

Conditions

Bladder Cancer; Renal Cell Carcinoma

Outcome Measures

Primary Outcomes (1)

• Severety of postoperative complications

  Clavien grading

  90 days

Study Arms (4)

Cx prospective

Cystectomy patients followed with prospective registration of complications

Other: Registration of complications

Cx retrospective

Cystectomy patients followed with retrospective registration of complications

Nx prospective

Nephrectomy patients followed with prospective registration of complications

Other: Registration of complications

Nx retrospective

Nephrectomy patients followed with retrospective registration of complications

Interventions

Registration of complications OTHER

Prospective registration

Cx prospective; Nx prospective

Eligibility Criteria

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

Study Population

Patients undergoing cystectomy or nephrectomy

You may qualify if:

• Age \> 18 years
• Competente and able individuals
• Consented participation

You may not qualify if:

• Failure to consent to participation

Sponsors & Collaborators

• Jørgen Bjerggaard Jensen: lead

Study Sites (1)

Aarhus University Hospital

Aarhus, Danmark, 8200, Denmark

Location

MeSH Terms

Conditions

Urinary Bladder Neoplasms; Carcinoma, Renal Cell

Condition Hierarchy (Ancestors)

Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urinary Bladder Diseases; Urologic Diseases; Male Urogenital Diseases; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Kidney Neoplasms; Kidney Diseases

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: February 10, 2017
• First Posted: February 14, 2017
• Study Start: September 1, 2016
• Primary Completion: February 1, 2018
• Study Completion: February 1, 2018
• Last Updated: June 27, 2018

Record last verified: 2018-06

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)