Mortality of Cancer Surgery During SARS CoV2 Pandemic

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

• Status: Completed
• Conditions: Cancer; SARS CoV 2 Infection
• Intervention / Treatment: Other: Surgery

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

Study Locations

• India
  • UP
    • Varanasi, UP, India, 221005
      • Banaras Hindu University

Participation Criteria

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

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Retrospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Pre covid; Cases operated one year prior to the date of declaration of corona pandemic in India	Other: Surgery; 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	Other: Surgery; 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	post operative deaths within one year	30 days
number of participants developing major or minor complications	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	Covid infection in health care workers	1 year

Collaborators and Investigators

• Sponsor: Banaras Hindu University

Study record dates

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: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19; Infections
• 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