COVID-19 Pandemic and General Surgery Emergencies

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

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.

Study Overview

• Status: Completed
• Conditions: Emergencies
• Intervention / Treatment: Other: Emergency general surgical admissions

Detailed Description

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.

• Study Type: Observational
• Enrollment (Actual): 750

Contacts and Locations

Study Locations

• Turkey
  • Ankara, Turkey, 06010
    • Gulhane Training and Research Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

All consecutive patients admitted during the first six months of the pandemic and patients admitted during the same period in 2019 at the department of general surgery, Gulhane Training and Research Hospital

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Retrospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Pre-pandemic period; Patients managed in the pre-pandemic period	Other: Emergency general surgical admissions; 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).
Pandemic period; Patients managed in the pandemic period	Other: Emergency general surgical admissions; 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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of general surgical emergencies	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.	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Complication rate	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.	1 month

Collaborators and Investigators

• Sponsor: Gulhane Training and Research Hospital

Study record dates

Study Major Dates

• Study Start (Actual): March 11, 2019
• Primary Completion (Actual): September 11, 2020
• Study Completion (Actual): September 11, 2020

Study Registration Dates

• First Submitted: December 27, 2020
• First Submitted That Met QC Criteria: December 28, 2020
• First Posted (Actual): December 29, 2020

Study Record Updates

• Last Update Posted (Actual): December 29, 2020
• Last Update Submitted That Met QC Criteria: December 28, 2020
• Last Verified: December 1, 2020

More Information

Terms related to this study

• Keywords: COVID-19; emergency treatment; pandemic; general surgery
• Additional Relevant MeSH Terms: Pathologic Processes; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; Disease Attributes; COVID-19; Emergencies
• Other Study ID Numbers: Gulhane2020-258

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: Study protocol will be seen on clicaltrials.gov

Drug and device information, study documents

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