Outcomes of Elective Colorectal Cancer Surgery During COVID 19 Pandemic: Implications for Cancer Care Policy
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|ClinicalTrials.gov Identifier: NCT04588909|
Recruitment Status : Active, not recruiting
First Posted : October 19, 2020
Last Update Posted : October 19, 2020
|Condition or disease||Intervention/treatment|
|Colo-rectal Cancer||Procedure: Colorectal resections|
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  and that oncology patients were likely to get deferred care with significant implications , 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.
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|
|Estimated Enrollment :||100 participants|
|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|
- Procedure: Colorectal resections
All patients admitted with colorectal cancer were subjected to various types of colorectal resections
- Early post operative mortality [ Time Frame: 30 days ]patients who died within 30 days following their surgery
- Early Post operative complications [ Time Frame: 30 days ]post operative complications will be graded as per clavien dindo grading system
- 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.
- 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
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
|Sher i Kashmir Institute of Medical Sciences|
|Srinagar, J&K, India, 190011|
|Study Chair:||Nisar A Chowdri||Government organisation|