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Surgical Management During the Era of COVID-19

3 de junho de 2021 atualizado por: Dr. Ather Enam, Aga Khan University

Surgical Management During the Era of COVID-19 at a Private Tertiary Care Hospital of Karachi, Pakistan: A Cross Sectional Study

In Lower middle-income countries (LMICs) like Pakistan with limited health care facilities the gravity of COVID 19 is severe. Effective management and implementation of processes and planning is imperative. In surgical procedures additional time is required to prepare for surgery in a suspected/confirmed case of COVID-19 in daily routines regardless of whether surgery would happen. Therefore, for effective management of surgical procedures the Aga Khan University, Karachi, Pakistan has established a COVID testing algorithm for effective management of the surgical patients.

The objectives of the study are

  1. To evaluate the outcomes of COVID testing algorithm established for surgery patients presenting to Aga Khan University Karachi, Pakistan
  2. To compare the outcomes among patients who underwent elective versus emergency surgery.

Visão geral do estudo

Status

Concluído

Condições

Descrição detalhada

The disease declared as corona virus disease 2019 (COVID-19) by the World Health Organization was initially known as severe acute respiratory syndrome corona virus 2 (SARS-CoV-2). It is caused by a single-stranded RNA virus that belongs to the corona virus family known as 2019-nCoV (SARS-CoV-2). The disease is highly contagious and transmitted mainly by droplets or close contact. The first case occurred in Wuhan, Hubei Province, China in December 2019 . On March 11, 2020, WHO declared COVID-19 as a pandemic disease and by March 26, 2020, it had spread to almost 199 countries and territories worldwide with more than 462680 cases and around 20834 deaths . The COVID-19 pandemic reached Pakistan on 26 February 2020, when a student in Karachi tested positive upon returning from Iran. By 18 March, cases had been registered in all four provinces. With a total of 3277; in Punjab there were 1493 cases, Sindh (881), Khyber Pakhtunkhwa (405) and Balochistan (191), Gilgit Baltistan (210), Azad Jammu and Kashmir (15) and Federal (ICT) (82).

As the global incidence of COVID-19 disease is increasing in different parts of the world the COVID-19 pandemic has disrupted the health care services , in terms of its capability to manage affected people and the ability to provide standard treatment for critically ill patients in a safe environment . Similarly, the surgical procedures are minimized or temporarily suspended to address the overwhelming and devastating increase in COVID-19 patient care needs. However, decisions regarding surgical intervention in this resource scarce time must undergo rigorous ethical and clinical evaluation . In this era, it is essential that all the health care providers must execute standardized essential perioperative measures including the use of Personal Protective Equipment (PPEs) to control disease transmission and avoid unwanted complications. All patients need to be managed as COVID-19 patients till confirmed by results. Elective procedures are recommended to be postponed and to consider only urgent, lifesaving procedures and oncologic surgeries that are associated with worse outcome if delayed.

In a Lower middle-income countries (LMICs) like Pakistan with limited health care facilities the gravity of COVID 19 is severe. Effective management and implementation of processes and planning is imperative. In surgical procedures additional time is required to prepare for surgery in a suspected/confirmed case of COVID-19 in daily routines regardless of whether surgery would happen. Therefore, for effective management of surgical procedures the Aga Khan University, Karachi, Pakistan has established a COVID testing algorithm for effective management of the surgical patients.

It was a cross sectional study conducted at the Aga Khan University Hospital Karachi, Pakistan, Department of Surgery. Nonprobability consecutive sampling technique was employed to recruit patients . The data for the study was collected on a Proforma from the patients' medical records from May 2020 onwards. The data was collected on patients' demographic, type of case (elective, orange or red), type of surgery, COVID screening (non-suspected or suspected case), COVID results (positive negative) and surgery outcome, classification of surgery according to specialties.

Ethical exemption was sorted. All the patient information was kept in lock and key. The data base was password protected and was only accessible by the research team. All the patient information was deidentified. When the patients were admitted to the hospital consent was taken from them, they were informed that their information will be used for research purpose and the study results will be published in group form and no individual information will be disclosed The data was analyzed by using SPSS version 22. Descriptive for qualitative variables was reported as frequency and percentages and was assessed by chi-square and fisher exact test. Bars charts for categorical variables and histogram/ line graphs were presented for quantitative variables. A p value of <0.05 was kept significant throughout the study.

Tipo de estudo

Observacional

Inscrição (Real)

6846

Contactos e Locais

Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.

Locais de estudo

    • Sindh
      • Karachi, Sindh, Paquistão, 74800
        • Aga Khan University

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

1 ano a 100 anos (Filho, Adulto, Adulto mais velho)

Aceita Voluntários Saudáveis

N/D

Gêneros Elegíveis para o Estudo

Tudo

Método de amostragem

Amostra Não Probabilística

População do estudo

All patients presenting for surgical procedures to Aga Khan University Hospital from May 2020 onwards were included

Descrição

Inclusion Criteria:

  • All patients presenting for surgical procedures to Aga Khan University Hospital from May 2020 onwards were included

Exclusion Criteria:

  • Patients who left against medical advice (LAMA)
  • Patients with missing information

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Prazo
The patients who underwent elective versus emergency surgery. 2. Frequency of Covid positive patients who underwent surgery or the surgery was deferred. the outcomes among patients who underwent elective versus emergency surgery.
Prazo: May to October 2020
May to October 2020
Frequency of Covid positive and negative patients presenting for surgery
Prazo: May to October 2020
May to October 2020

Colaboradores e Investigadores

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Patrocinador

Publicações e links úteis

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Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados ​​pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo (Real)

1 de maio de 2020

Conclusão Primária (Real)

31 de outubro de 2020

Conclusão do estudo (Real)

1 de maio de 2021

Datas de inscrição no estudo

Enviado pela primeira vez

31 de maio de 2021

Enviado pela primeira vez que atendeu aos critérios de CQ

2 de junho de 2021

Primeira postagem (Real)

3 de junho de 2021

Atualizações de registro de estudo

Última Atualização Postada (Real)

8 de junho de 2021

Última atualização enviada que atendeu aos critérios de controle de qualidade

3 de junho de 2021

Última verificação

1 de junho de 2021

Mais Informações

Termos relacionados a este estudo

Informações sobre medicamentos e dispositivos, documentos de estudo

Estuda um medicamento regulamentado pela FDA dos EUA

Não

Estuda um produto de dispositivo regulamentado pela FDA dos EUA

Não

Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .

Ensaios clínicos em COVID 19

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