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?

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.

Study Overview

• Status: Completed
• Conditions: Surgery; COVID; Complication of Surgical Procedure

• Study Type: Observational
• Enrollment (Actual): 120

Contacts and Locations

Study Locations

• France
  • Nice, France, 06300
    • Chu de Nice

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patient selected for elective surgery or emergency surgery in the time frame

Description

Inclusion Criteria:

• naive patient for elective or emergency urological surgery

Exclusion Criteria:

• minor less than 18 year old

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Naive patients; Group of naive patients who have undergone elective or emergency surgery during the study period

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire de Nice

Study record dates

Study Major Dates

• Study Start (Actual): March 15, 2020
• Primary Completion (Actual): April 17, 2020
• Study Completion (Actual): May 1, 2020

Study Registration Dates

• First Submitted: April 14, 2020
• First Submitted That Met QC Criteria: April 17, 2020
• First Posted (Actual): April 20, 2020

Study Record Updates

• Last Update Posted (Actual): May 15, 2020
• Last Update Submitted That Met QC Criteria: May 14, 2020
• Last Verified: April 1, 2020

More Information

Terms related to this study

• Other Study ID Numbers: 20urocovid01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: no data sharing plan has been established

Drug and device information, study documents

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