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

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.

Study Overview

• Status: Unknown
• Conditions: Colo-rectal Cancer
• Intervention / Treatment: 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 Type: Observational
• Enrollment (Anticipated): 100

Contacts and Locations

Study Locations

• India
  • J&K
    • Srinagar, J&K, India, 190011
      • Sher i Kashmir Institute of Medical Sciences

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

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

Description

Inclusion Criteria:

• colorectal cancer patients subjected to surgery during COVID 19 pandemic

Exclusion Criteria:

• SARS CoV 2 infected patients

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Retrospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Early post operative mortality	patients who died within 30 days following their surgery	30 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Early Post operative complications	post operative complications will be graded as per clavien dindo grading system	30 days
Incidence of SARS CoV2 infectivity among health care providers providing direct care to involved patients	determine whether any health care worker involved with the care of this cohort of patients got infected with SARS CoV 2.	30 days
Rate of hospital acquired SARS CoV 2 infection among operated patients.	Determine whether any patient from the cohort got infected with SARS CoV 2 during their hospital stay or immediately after discharge	30 days

Collaborators and Investigators

• Sponsor: Sheri Kashmir Institute of Medical Sciences
• Investigators: Study Chair: Nisar A Chowdri, Government organisation

Study record dates

Study Major Dates

• Study Start (Actual): March 23, 2020
• Primary Completion (Actual): September 22, 2020
• Study Completion (Anticipated): October 22, 2020

Study Registration Dates

• First Submitted: October 14, 2020
• First Submitted That Met QC Criteria: October 14, 2020
• First Posted (Actual): October 19, 2020

Study Record Updates

• Last Update Posted (Actual): October 19, 2020
• Last Update Submitted That Met QC Criteria: October 14, 2020
• Last Verified: October 1, 2020

More Information

Terms related to this study

• Keywords: colorectal cancer; COVID 19 pandemic
• Additional Relevant MeSH Terms: Digestive System Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Neoplasms; Pneumonia, Viral; Pneumonia; Lung Diseases; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; COVID-19; Colorectal Neoplasms
• Other Study ID Numbers: 73/2020 (Supl 2)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No