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COVID-19 Pandemic and General Surgery Emergencies

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04686708
Recruitment Status : Completed
First Posted : December 29, 2020
Last Update Posted : December 29, 2020
Sponsor:
Information provided by (Responsible Party):
Suleyman Utku Celik, Gulhane Training and Research Hospital

Study Description
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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.

Condition or disease Intervention/treatment
Emergencies 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 Design
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Study Type : Observational
Actual Enrollment : 750 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Impact of the COVID-19 Pandemic on Emergency General Surgery Outcomes: a Single-center Cohort Study
Actual Study Start Date : March 11, 2019
Actual Primary Completion Date : September 11, 2020
Actual Study Completion Date : September 11, 2020

Resource links provided by the National Library of Medicine


Groups and Cohorts
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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).


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes 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
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04686708


Locations
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Turkey
Gulhane Training and Research Hospital
Ankara, Turkey, 06010
Sponsors and Collaborators
Gulhane Training and Research Hospital
More Information
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Responsible Party: Suleyman Utku Celik, Principal Investigator, Gulhane Training and Research Hospital
ClinicalTrials.gov Identifier: NCT04686708    
Other Study ID Numbers: Gulhane2020-258
First Posted: December 29, 2020    Key Record Dates
Last Update Posted: December 29, 2020
Last Verified: December 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Study protocol will be seen on clicaltrials.gov

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Suleyman Utku Celik, Gulhane Training and Research Hospital:
COVID-19
emergency treatment
general surgery
pandemic
Additional relevant MeSH terms:
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COVID-19
Emergencies
Respiratory Tract Infections
Infections
Pneumonia, Viral
Pneumonia
Virus Diseases
Coronavirus Infections
 Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases
Disease Attributes
Pathologic Processes