Mortality of Cancer Surgery During SARS CoV2 Pandemic | NCT05240378

Studies
Mortality of Cancer Surgery During SARS CoV2 Pandemic

NCT05240378

Sponsor

Banaras Hindu University

Status

Completed

Last Update Posted

Mar 3, 2022Actual

Enrollment

1,576Actual

Phase

Not provided

Conditions

SARS CoV 2 Infection
Cancer

Interventions

Surgery

Countries

India

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2022

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 29, 2021Actual

Primary Completion Date

Dec 31, 2021Actual

Completion Date

Jan 15, 2022Actual

First Submitted Date

Feb 12, 2022

First Submission Date that Met QC Criteria

Feb 12, 2022

First Posted Date

Feb 15, 2022Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 15, 2022

Last Update Posted Date

Mar 3, 2022Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

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

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

1,576Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Pre covid		Cases operated one year prior to the date of declaration of corona pandemic in India	Other: Surgery
post covid		cases operated from the date of declaration of corona pandemic to one year after	Other: Surgery

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Surgery	Other	Surgery for cancer as per the stage of the disease and protocol	Pre covid post covid

Outcomes Module

Primary Outcomes

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 Outcomes

Measure	Description	Time Frame
number of health care worker with SARS CoV2 infection	Covid infection in health care workers	1 year

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

All patients operated during the study period

Exclusion Criteria:

None

Accepts Healthy Volunteers

Not provided

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

99 Years

Standard Ages

AdultOlder Adult

Study Population

All cases of cancer operated between April 2019 to May 2021

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Manoj Pandey, MS, PhD	Banaras Hindu University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Banaras Hindu University		Varanasi	Uttar Pradesh	221005	India

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

IPD will be shared on reasonable request as per Indian law

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D000086382	COVID-19
D009369	Neoplasms

Ancestor Terms

ID	Term
D011024	Pneumonia, Viral
D011014	Pneumonia
D012141	Respiratory Tract Infections
D007239	Infections

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D013514	Surgical Procedures, Operative

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided