Clinical trial NCT04588909: Outcomes of Elective Colorectal Cancer Surgery During COVID 19 Pandemic: Implications for Cancer Care Policy
Official title: Outcomes of Elective Colorectal Cancer Surgery During COVID 19 Pandemic: Implications for Cancer Care Policy
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Colo-rectal Cancer
Keywords: colorectal cancer
COVID 19 pandemic
Lead sponsor: Sheri Kashmir Institute of Medical Sciences
Sponsor class: OTHER
First posted: 2020-10-19
Enrollment: 100
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: All Colorectal cancer patients subjected to both elective and emergency surgery during COVID 19 pandemic.

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.

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.

Eligibility criteria: Inclusion Criteria:

* colorectal cancer patients subjected to surgery during COVID 19 pandemic

Exclusion Criteria:

* SARS CoV 2 infected patients

Primary outcomes:
measure: Early post operative mortality
timeFrame: 30 days
Secondary outcomes:
measure: Early Post operative complications
timeFrame: 30 days
measure: Incidence of SARS CoV2 infectivity among health care providers providing direct care to involved patients
timeFrame: 30 days
measure: Rate of hospital acquired SARS CoV 2 infection among operated patients.
timeFrame: 30 days
Other outcomes:
Locations:
city: Srinagar
country: India
facility: Sher i Kashmir Institute of Medical Sciences
state: J&K
Study officials:
affiliation: Government organisation
name: Nisar A Chowdri
role: STUDY_CHAIR
References: