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Completed

NCT Number: NCT04352699

Outcomes of Urological Surgery During Periods of Social COVID-19 Containemnt: 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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

CHU de Nice

Nice, 06300, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • naive patient for elective or emergency urological surgery

Exclusion criteria

  • minor less than 18 year old

Treatment and study plan

Primary outcomes

  1. Rate of UCI admission for surgery-related complication

    Time frame: 1 month and a half

    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

Secondary outcomes

  1. Rate of surgery-specific death

    Time frame: 1 month and a half

    Number of patient dead from Covid after surgery out of number of dead patients in the same time frame within the institution

  2. Rate of coronaviruse positive serologies

    Time frame: 1 month and a half

    Number of positives serologies within the cohort over a 1 month follow-up period. And coronaviruse related symptoms

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Nice

Other

Registry information

Official study 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?

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Apr 20, 2020
Registry last updated
May 15, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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