NCT04686708

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
750

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2019

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 11, 2019

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 11, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 11, 2020

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

December 27, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 29, 2020

Completed
Last Updated

December 29, 2020

Status Verified

December 1, 2020

Enrollment Period

1.5 years

First QC Date

December 27, 2020

Last Update Submit

December 28, 2020

Conditions

Keywords

COVID-19emergency treatmentgeneral surgerypandemic

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Complication rate

    1 month

Study Arms (2)

Pre-pandemic period

Patients managed in the pre-pandemic period

Other: Emergency general surgical admissions

Pandemic period

Patients managed in the pandemic period

Other: Emergency general surgical admissions

Interventions

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 periodPre-pandemic period

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Gulhane Training and Research Hospital

Ankara, 06010, Turkey (Türkiye)

Location

MeSH Terms

Conditions

EmergenciesCOVID-19

Condition Hierarchy (Ancestors)

Disease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsPneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

December 27, 2020

First Posted

December 29, 2020

Study Start

March 11, 2019

Primary Completion

September 11, 2020

Study Completion

September 11, 2020

Last Updated

December 29, 2020

Record last verified: 2020-12

Data Sharing

IPD Sharing
Will not share

Study protocol will be seen on clicaltrials.gov

Locations