COVID-19 Pandemic and General Surgery Emergencies

Completed

• Conditions: Emergencies
• Interventions: Other: Emergency general surgical admissions

• Registration Number: NCT04686708
• Lead Sponsor: Gulhane Training and Research Hospital

Brief Summary

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.

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 Timeline

• Study Start: 2019-03-11
• Primary Completion: 2020-09-11
• Study Completion: 2020-09-11
• Status Verified: 2020-12
• Study First Submitted: 2020-12-27
• Study First Submitted QC: 2020-12-28
• Last Update Submitted: 2020-12-28
• Study First Posted: 2020-12-29
• Last Update Posted: 2020-12-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 750

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Pre-pandemic period	Emergency general surgical admissions	Patients managed in the pre-pandemic period
Pandemic period	Emergency general surgical admissions	Patients managed in the pandemic period

Primary Outcome Measures

Name	Time	Method
Incidence of general surgical emergencies	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 Outcome Measures

Name	Time	Method
Complication rate	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.

Trial Locations

Locations (1)

Gulhane Training and Research Hospital; 🇹🇷 Ankara, Turkey