NCT04450277

Brief Summary

Emergency general surgical care during the COVID-19 pandemic presents a unique set of considerations and challenges. Patients presenting with acute surgical conditions and concomitant COVID-19 infection have higher risk of mortality and morbidity. The investigators present their experience with COVID-19 positive patients presenting with acute surgical conditions and reviewed the implementation of a protocolized pathway to mitigate the impact of COVID-19 infection.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
15

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Apr 2020

Shorter than P25 for all trials

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2020

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2020

Completed
25 days until next milestone

First Submitted

Initial submission to the registry

June 25, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 29, 2020

Completed
Last Updated

July 7, 2020

Status Verified

June 1, 2020

Enrollment Period

2 months

First QC Date

June 25, 2020

Last Update Submit

July 1, 2020

Conditions

Outcome Measures

Primary Outcomes (1)

  • Surgical morbidity in patients with COVID-19 infection and general surgical conditions

    Follow up 1 month

Interventions

Emergency surgery vs conservative management

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

A propsective review was performed of all patients with laboratory-confirmed COVID-19 infection who presented with acute general surgical conditions to Khoo Teck Puat Hospital (KTPH), in the period of 1st April 2020 to 31st May 2020. KTPH is a 795-bed regional general hospital in Singapore that serves approximately half a million people in the northern part of the city state. A confirmed case of COVID-19 was defined by a positive result on a reverse-transcriptase-polymerase-chain-reaction (RT-PCR) assay of a specimen collected on a nasopharyngeal swab. Patients underwent testing on admission if identified as high risk as per national guidelines, or upon developing respiratory symptoms during inpatient stay.

You may qualify if:

  • All patients with emergency surgical conditions and tested positive for COVID-19 infection

You may not qualify if:

  • Nil

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Khoo Teck Puat Hospital

Singapore, 768828, Singapore

Location

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
1 Month
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 25, 2020

First Posted

June 29, 2020

Study Start

April 1, 2020

Primary Completion

May 31, 2020

Study Completion

May 31, 2020

Last Updated

July 7, 2020

Record last verified: 2020-06

Data Sharing

IPD Sharing
Will not share

No plan to share individual participant data due to personal data protection act

Locations