Mortality of Cancer Surgery During SARS CoV2 Pandemic
February 15, 2022 updated by: Manoj Pandey, Banaras Hindu University
Preoperative Screening for COVID-19 and Strict COVID Cancer Protocol Helps to Reduce Postoperative Infection, Mortality and Morbidity in Cancer Patients Undergoing Surgery. A Comparative Study
The impact of cancer surgery during covid epidemic is not clear.
The published reports show contradictory findings that extend from no change in mortality to increased mortality, further no data on exposure and outcome of health care worker is available.
This study is designed to address the above questions
Study Overview
Detailed Description
This is a retrospective study from the prospectively collected data that is extracted from the electronic database of Department of Surgical Oncology, IMS, BHU The data is inform of two cohorts one extending from April 2019-April 2020 and other from May 2020 to May 2021 i.e. pre covid and during covid pandemic
Study Type
Observational
Enrollment (Actual)
1576
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
UP
-
Varanasi, UP, India, 221005
- Banaras Hindu University
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 99 years (Adult, Older Adult)
Accepts Healthy Volunteers
N/A
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
All cases of cancer operated between April 2019 to May 2021
Description
Inclusion Criteria:
- All patients operated during the study period
Exclusion Criteria:
- None
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Retrospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Pre covid
Cases operated one year prior to the date of declaration of corona pandemic in India
|
Surgery for cancer as per the stage of the disease and protocol
|
|
post covid
cases operated from the date of declaration of corona pandemic to one year after
|
Surgery for cancer as per the stage of the disease and protocol
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
30 day mortality
Time Frame: 30 days
|
post operative deaths within one year
|
30 days
|
|
number of participants developing major or minor complications
Time Frame: 30 days
|
Surgical complications classified as per Clavien Dindo classification
|
30 days
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
number of health care worker with SARS CoV2 infection
Time Frame: 1 year
|
Covid infection in health care workers
|
1 year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
October 29, 2021
Primary Completion (Actual)
December 31, 2021
Study Completion (Actual)
January 15, 2022
Study Registration Dates
First Submitted
February 12, 2022
First Submitted That Met QC Criteria
February 12, 2022
First Posted (Actual)
February 15, 2022
Study Record Updates
Last Update Posted (Actual)
March 3, 2022
Last Update Submitted That Met QC Criteria
February 15, 2022
Last Verified
February 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Dean/2021/EC/3004
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Undecided
IPD Plan Description
IPD will be shared on reasonable request as per Indian law
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.