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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05240378
Other study ID # Dean/2021/EC/3004
Secondary ID
Status Completed
Phase
First received
Last updated
Start date October 29, 2021
Est. completion date January 15, 2022

Study information

Verified date February 2022
Source Banaras Hindu University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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


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


Recruitment information / eligibility

Status Completed
Enrollment 1576
Est. completion date January 15, 2022
Est. primary completion date December 31, 2021
Accepts healthy volunteers
Gender All
Age group 18 Years to 99 Years
Eligibility Inclusion Criteria: - All patients operated during the study period Exclusion Criteria: - None

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Surgery
Surgery for cancer as per the stage of the disease and protocol

Locations

Country Name City State
India Banaras Hindu University Varanasi UP

Sponsors (1)

Lead Sponsor Collaborator
Banaras Hindu University

Country where clinical trial is conducted

India, 

Outcome

Type Measure Description Time frame Safety issue
Primary 30 day mortality post operative deaths within one year 30 days
Primary number of participants developing major or minor complications Surgical complications classified as per Clavien Dindo classification 30 days
Secondary number of health care worker with SARS CoV2 infection Covid infection in health care workers 1 year
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