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Completed

NCT Number: NCT04686708

COVID-19 Pandemic and General Surgery Emergencies

A retrospective analysis of emergency general surgical admissions during the first six months of the pandemic (from March 11 to September 11, 2020) and the same period in 2019, will be conducted.

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Key information

Conditions

Emergencies COVID-19 Coronaviridae Infections Coronavirus Infections Disease Attributes Infections Lung Diseases Nidovirales Infections Pathologic Processes Pathological Conditions, Signs and Symptoms Pneumonia Pneumonia, Viral RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Gulhane Training and Research Hospital

Ankara, 06010, Turkey (Türkiye)

About this study

The volume and disease severity of emergency general surgery admissions between the first six-month period of the pandemic and the similar time period in the prepandemic period in 2019 will be compared.

Patients admitted during the first six months of the COVID-19 pandemic, from March 11 to September 11, 2020, will be included. As a comparison group, similar data will be collected on patients admitted to the general surgery department during the same period in 2019. Patient and disease characteristics, including demographics, initial leukocyte and C-reactive protein levels, diagnosis, treatment strategies, complications, duration of hospital stay, 30-day rehospitalization rate, and 30-day reoperation rate will be reviewed. Complications will be classified according to Clavien-Dindo classification. Tokyo Guidelines 2018/2013 will be used to assess the severity of the acute cholecystitis.

After the patients are divided into two groups: (1) prepandemic period and (2) pandemic period, descriptive statistics will be presented as the medians and ranges, and frequencies (%). Associations between variables will be evaluated using the Mann-Whitney U test (for continuous variables) or Pearson's chi-square and Fisher exact tests (for categorical variables), where appropriate.

Who can participate

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

Inclusion criteria

  • Patients aged 18 years and older
  • Patients admitted during the first six months of the pandemic, from March 11 to September 11, 2020, and patients admitted during the same period in 2019

Exclusion criteria

  • Patients younger than 18 years
  • Patients positive for COVID-19
  • Patients required elective surgery
  • Patients re-operated because of a postoperative complication of an elective surgical procedure

Treatment and study plan

Emergency general surgical admissions

Other

All emergency general surgical admissions are admitted initially to the emergency department and then referred to the general surgery department for further management (medical, interventional, or surgical approaches).

Primary outcomes

  1. Incidence of general surgical emergencies

    Time frame: 6 months

    The incidence of surgical emergencies (acute appendicitis, acute cholecystitis, bowel obstruction, incarcerated or strangulated hernia, ulcer perforation, diverticulitis, mesenteric ischemia, acute pancreatitis, abdominal trauma, and perianal abscess) admitted to the general surgery service in the first six months of the pandemic and in the same period in 2019 will be compared separately and together.

Secondary outcomes

  1. Complication rate

    Time frame: 1 month

    30-day complication rates of surgical emergencies will be compared between the prepandemic period and the COVID-19 pandemic period. Complications will be graded according to the Clavien-Dindo classification system.

Sponsors and collaborators

Lead sponsor

Gulhane Training and Research Hospital

Other Gov

Registry information

Official study title

Impact of the COVID-19 Pandemic on Emergency General Surgery Outcomes: a Single-center Cohort Study

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Dec 29, 2020
Registry last updated
Dec 29, 2020

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

View the official ClinicalTrials.gov record (opens in a new tab)

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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