NCT05240378

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,576

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2021

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 29, 2021

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2021

Completed
15 days until next milestone

Study Completion

Last participant's last visit for all outcomes

January 15, 2022

Completed
28 days until next milestone

First Submitted

Initial submission to the registry

February 12, 2022

Completed
3 days until next milestone

First Posted

Study publicly available on registry

February 15, 2022

Completed
Last Updated

March 3, 2022

Status Verified

February 1, 2022

Enrollment Period

2 months

First QC Date

February 12, 2022

Last Update Submit

February 15, 2022

Conditions

Outcome Measures

Primary Outcomes (2)

  • 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 (1)

  • number of health care worker with SARS CoV2 infection

    1 year

Study Arms (2)

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

SurgeryOTHER

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

Pre covidpost covid

Eligibility Criteria

Age18 Years - 99 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

All cases of cancer operated between April 2019 to May 2021

You may qualify if:

  • All patients operated during the study period

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Banaras Hindu University

Varanasi, Uttar Pradesh, 221005, India

Location

MeSH Terms

Conditions

COVID-19Neoplasms

Interventions

Surgical Procedures, Operative

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Study Officials

  • Manoj Pandey, MS, PhD

    Banaras Hindu University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

February 12, 2022

First Posted

February 15, 2022

Study Start

October 29, 2021

Primary Completion

December 31, 2021

Study Completion

January 15, 2022

Last Updated

March 3, 2022

Record last verified: 2022-02

Locations