Clinical Trials Directory

Trials / Completed

CompletedNCT04352699

Outcomes of Urological Surgery During Periods of Social COVID-19 Containemnt: is it Reasonable to Limit Access to Surgical Care for All?

Outcomes of naïve Patients Operated on for an Urological Cancer or Emergency During Periods of Social COVID-19 Containment: is it Reasonable to Limit Access to Surgical Care for All?

Status
Completed
Phase
Study type
Observational
Enrollment
120 (actual)
Sponsor
Centre Hospitalier Universitaire de Nice · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

Summary

The French healthcare system has been strongly mobilized since the start of the Covid-19 epidemic to take care of patients with Covid-19. This should not overlook the fact that some treatments, surgeries and examinations of non-Covid-19 patients must imperatively be maintained according to the assessment of their risk-benefit balance. In context, it appears that this is not always the case. In addition to the necessary social containment measures, there are general limitations on patient access to the operating theater, neglecting the individual interest of naive non-Covid-19 patients. Certain studies which report a higher and earlier risk of death of undetected and ultimately operated Covid-19 patients has reinforced, as a precaution, the massive deprogramming of naive patients and the restrictive access of surgical care for all. We believe that this could lead to a risk of delayed treatments and renunciation of care for naive patients who should not be considered at risk a priori in the event of surgery. The individual clinical and local health context should be first considered for appropriate surgical decision-making. As such, the French Department of Health and Human Services (DGS) has given general guidelines regarding the maintenance of follow-up and care for non-Covid-19 patients in this context of containment and major mobilization of health care professionals to care for people with COVID. Surgeries which could not be postponed because of the patient's status or if their postponement exposed to a significant risk of loss of chance, if needed in the light of the recommendations issued by learned societies, were concerned. In this sense, the investigator have selected the naive Covid-19 patients from Nice Hospital who should benefit from elective or urgent urological surgeries, taking into account their individual risk and the territorial epidemic rate. Their rate of ICU stays following their surgery has been analysed and their surgical follow-up outcomes during the epidemic period evaluated, according to the anti-Covid-19 measures established in Nice Hospital by comparing them to an earlier period without Covid-19.

Conditions

Timeline

Start date
2020-03-15
Primary completion
2020-04-17
Completion
2020-05-01
First posted
2020-04-20
Last updated
2020-05-15

Locations

1 site across 1 country: France

Source: ClinicalTrials.gov record NCT04352699. Inclusion in this directory is not an endorsement.