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Outcomes of Elective Colorectal Cancer Surgery During COVID 19 Pandemic: Implications for Cancer Care Policy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04588909
Recruitment Status : Active, not recruiting
First Posted : October 19, 2020
Last Update Posted : October 19, 2020
Sponsor:
Information provided by (Responsible Party):
ASIF MEHRAJ, Sheri Kashmir Institute of Medical Sciences

Study Description
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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.

Condition or disease Intervention/treatment
Colo-rectal Cancer Procedure: Colorectal resections

Detailed Description:

INTRODUCTION Health systems all across the globe have been under tremendous stress due to COVID 19 pandemic. Based on information suggesting that India was faring better compared to the west [1] and that oncology patients were likely to get deferred care with significant implications [2], the department of general surgery (colorectal division) took a conscious decision to continue offering elective cancer surgeries albeit in less numbers.in this study we will try to collect 30 day post operative outcome data of elective colorectal cancer resections at our department and discuss the implications of our decision.

Such reports are still sparsely reported from Covid hotspots around the world.

Methods:

We will analyze the prospective database of the department of colorectal surgery at Sheri Kashmir Institute of Medical Sciences, Srinagar, a tertiary referral centre and a high volume centre for colorectal cancer surgeries ( with more than 300 colorectal cancer surgeries performed every year) in North India wef 23rd March to 22nd September 2020 (6 months).and report outcomes of all elective colorectal cancer surgeries. Each patient will be followed up for 30 days, thereby last follow up will end on 22nd October 2020.

All colorectal cancer patients subjected to elective and emergency surgeries during COVID 19 pandemic will be included. Patients who were positive for SARS CoV2 (Severe acute respiratory syndrome coronavirus 2) infection and underwent surgery for colorectal cancer will be excluded.

The data will be statistically analysed using Statistical Product and Statistical Solutions(SPSS) sotware v 23. All categorical variables will be shown in the form of frequency and percentage. Continuous variables will further be analysed by independent t test and using multivariate analysis.

Study Design
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Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Outcomes of Elective Colorectal Cancer Surgery During COVID 19 Pandemic: Implications for Cancer Care Policy
Actual Study Start Date : March 23, 2020
Actual Primary Completion Date : September 22, 2020
Estimated Study Completion Date : October 22, 2020

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Intervention Details:
  • Procedure: Colorectal resections
    All patients admitted with colorectal cancer were subjected to various types of colorectal resections

Outcome Measures
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Primary Outcome Measures :
  1. Early post operative mortality [ Time Frame: 30 days ]
    patients who died within 30 days following their surgery


Secondary Outcome Measures :
  1. Early Post operative complications [ Time Frame: 30 days ]
    post operative complications will be graded as per clavien dindo grading system

  2. Incidence of SARS CoV2 infectivity among health care providers providing direct care to involved patients [ Time Frame: 30 days ]
    determine whether any health care worker involved with the care of this cohort of patients got infected with SARS CoV 2.

  3. Rate of hospital acquired SARS CoV 2 infection among operated patients. [ Time Frame: 30 days ]
    Determine whether any patient from the cohort got infected with SARS CoV 2 during their hospital stay or immediately after discharge


Eligibility Criteria
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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
All Colorectal cancer patients subjected to both elective and emergency surgery during COVID 19 pandemic.
Criteria

Inclusion Criteria:

  • colorectal cancer patients subjected to surgery during COVID 19 pandemic

Exclusion Criteria:

  • SARS CoV 2 infected patients
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04588909


Locations
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India
Sher i Kashmir Institute of Medical Sciences
Srinagar, J&K, India, 190011
Sponsors and Collaborators
Sheri Kashmir Institute of Medical Sciences
Investigators
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Study Chair: Nisar A Chowdri Government organisation
More Information
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Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
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Responsible Party: ASIF MEHRAJ, Senior Resident, Sheri Kashmir Institute of Medical Sciences
ClinicalTrials.gov Identifier: NCT04588909    
Other Study ID Numbers: 73/2020 (Supl 2)
First Posted: October 19, 2020    Key Record Dates
Last Update Posted: October 19, 2020
Last Verified: October 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by ASIF MEHRAJ, Sheri Kashmir Institute of Medical Sciences:
colorectal cancer
COVID 19 pandemic
Additional relevant MeSH terms:
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COVID-19
Colorectal Neoplasms
Respiratory Tract Infections
Infections
Pneumonia, Viral
Pneumonia
Virus Diseases
Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
 Respiratory Tract Diseases
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases