NCT04588909

Brief Summary

Due to COVID 19 (Corona virus disease)pandemic, majority of surgeries, including surgery for cancer patients got delayed across the globe. Surgeries were limited to emergency set up only. At our institute we tried to perform colorectal cancer surgeries through out the pandemic, albeit in less numbers, as we thought cancer in itself is an emergency setting. we are planning to analyse the prospectively managed database of this particular group of patients over a period of last six 6 months and look out at 30 day post operative morbidity and mortality. Besides we will try to analyse the implications of our decision to carry on with cancer surgeries in terms of number of health care workers who got infected while being involved in primary care of these patients.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Mar 2020

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

March 23, 2020

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 22, 2020

Completed
22 days until next milestone

First Submitted

Initial submission to the registry

October 14, 2020

Completed
5 days until next milestone

First Posted

Study publicly available on registry

October 19, 2020

Completed
3 days until next milestone

Study Completion

Last participant's last visit for all outcomes

October 22, 2020

Completed
Last Updated

October 19, 2020

Status Verified

October 1, 2020

Enrollment Period

6 months

First QC Date

October 14, 2020

Last Update Submit

October 14, 2020

Conditions

Keywords

colorectal cancerCOVID 19 pandemic

Outcome Measures

Primary Outcomes (1)

  • Early post operative mortality

    patients who died within 30 days following their surgery

    30 days

Secondary Outcomes (3)

  • Early Post operative complications

    30 days

  • Incidence of SARS CoV2 infectivity among health care providers providing direct care to involved patients

    30 days

  • Rate of hospital acquired SARS CoV 2 infection among operated patients.

    30 days

Interventions

All patients admitted with colorectal cancer were subjected to various types of colorectal resections

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

All Colorectal cancer patients subjected to both elective and emergency surgery during COVID 19 pandemic.

You may qualify if:

  • colorectal cancer patients subjected to surgery during COVID 19 pandemic

You may not qualify if:

  • SARS CoV 2 infected patients

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sher i Kashmir Institute of Medical Sciences

Srinagar, Jammu and Kashmir, 190011, India

Location

MeSH Terms

Conditions

Colonic NeoplasmsColorectal NeoplasmsCOVID-19

Condition Hierarchy (Ancestors)

Intestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal DiseasesPneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Study Officials

  • Nisar A Chowdri

    Government organisation

    STUDY CHAIR

Study Design

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

Study Record Dates

First Submitted

October 14, 2020

First Posted

October 19, 2020

Study Start

March 23, 2020

Primary Completion

September 22, 2020

Study Completion

October 22, 2020

Last Updated

October 19, 2020

Record last verified: 2020-10

Data Sharing

IPD Sharing
Will not share

Locations