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

Colo-rectal Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04588909
• Other study ID #: 73/2020 (Supl 2)
• Status: Active, not recruiting
• Start date: March 23, 2020
• Est. completion date: October 22, 2020

Study information

• Verified date: October 2020
• Source: Sheri Kashmir Institute of Medical Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 100
• Est. completion date: October 22, 2020
• Est. primary completion date: September 22, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• colorectal cancer patients subjected to surgery during COVID 19 pandemic

Exclusion Criteria:

• SARS CoV 2 infected patients

Related Conditions & MeSH terms

• Colo-rectal Cancer
• Colorectal Neoplasms

Intervention

Procedure:
• Colorectal resections
All patients admitted with colorectal cancer were subjected to various types of colorectal resections

Locations

Country	Name	City	State
India	Sher i Kashmir Institute of Medical Sciences	Srinagar	J&K

Sponsors (1)

Lead Sponsor	Collaborator
Sheri Kashmir Institute of Medical Sciences

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Early post operative mortality	patients who died within 30 days following their surgery	30 days
Secondary	Early Post operative complications	post operative complications will be graded as per clavien dindo grading system	30 days
Secondary	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
Secondary	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