Mortality of Cancer Surgery During SARS CoV2 Pandemic

Sponsor

Banaras Hindu University (Other)

Overall Status

Completed

CT.gov ID

NCT05240378

Collaborator

(none)

1,576

Enrollment

Location

2.6

Actual Duration (Months)

615

Patients Per Site Per Month

Study Details

Study Description

Brief 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

Condition or Disease	Intervention/Treatment	Phase
SARS CoV 2 Infection Cancer	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 Design

Study Type:

Observational

Actual Enrollment :

1576 participants

Observational Model:

Cohort

Time Perspective:

Retrospective

Official Title:

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

Actual Study Start Date :

Oct 29, 2021

Actual Primary Completion Date :

Dec 31, 2021

Actual Study Completion Date :

Jan 15, 2022

Arms and Interventions

Arm	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

Arm

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

Outcome Measures

Primary Outcome Measures

30 day mortality [30 days]
post operative deaths within one year
number of participants developing major or minor complications [30 days]
Surgical complications classified as per Clavien Dindo classification

Secondary Outcome Measures

number of health care worker with SARS CoV2 infection [1 year]
Covid infection in health care workers

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 99 Years

Sexes Eligible for Study:

All

Inclusion Criteria:

All patients operated during the study period

Exclusion Criteria:

None

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Banaras Hindu University	Varanasi	UP	India	221005

Sponsors and Collaborators

Banaras Hindu University

Investigators

Principal Investigator: Manoj Pandey, MS, PhD, Banaras Hindu University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Manoj Pandey, Professor, Banaras Hindu University

ClinicalTrials.gov Identifier:

NCT05240378

Other Study ID Numbers:

Dean/2021/EC/3004

First Posted:

Feb 15, 2022

Last Update Posted:

Mar 3, 2022

Last Verified:

Feb 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Infections

COVID-19

Study Results

No Results Posted as of Mar 3, 2022