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

Surgery Clinical Trial

Official title:

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?

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04352699
• Other study ID #: 20urocovid01
• Status: Completed
• Start date: March 15, 2020
• Est. completion date: May 1, 2020

Study information

• Verified date: April 2020
• Source: Centre Hospitalier Universitaire de Nice
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: May 1, 2020
• Est. primary completion date: April 17, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• naive patient for elective or emergency urological surgery

Exclusion Criteria:

• minor less than 18 year old

Related Conditions & MeSH terms

• Complication of Surgical Procedure
• COVID
• Surgery

Locations

Country	Name	City	State
France	CHU de Nice	Nice

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Nice

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of UCI admission for surgery-related complication	Admission Rate is defined by the number of patient admitted to ICU due to surgical-related complication during 1 month and a half included in the Covid-19 period out of the number of operated patient in the same time within the institution	1 month and a half
Secondary	Rate of surgery-specific death	Number of patient dead from Covid after surgery out of number of dead patients in the same time frame within the institution	1 month and a half
Secondary	Rate of coronaviruse positive serologies	Number of positives serologies within the cohort over a 1 month follow-up period. And coronaviruse related symptoms	1 month and a half