Colo-rectal CancerNCT04588909
Outcomes of Elective Colorectal Cancer Surgery During COVID 19 Pandemic: Implications for Cancer Care Policy
An observational study of Colo-rectal Cancer, run by Sheri Kashmir Institute of Medical Sciences at 1 site in India.
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Colo-rectal Cancer
- What is being tested?
- Colorectal resections
- Type of treatment
- Surgery or procedure
- How many people
- 100 participants
- Where
- 1 siteIndia
- Study dates
- 23 Mar 2020to 22 Oct 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: All Colorectal cancer patients subjected to both elective and emergency surgery during COVID 19 pandemic.
Who may be able to join
- colorectal cancer patients subjected to surgery during COVID 19 pandemic
Who cannot join
- SARS CoV 2 infected patients
Trial locations and contacts
1 site in 1 country.
India1 site
Sher i Kashmir Institute of Medical Sciences
Srinagar, Jammu and Kashmir, 190011
About this study
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.
Read the 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.
- Conditions
- Colo-rectal Cancer
- Being tested
- Colorectal resections
- Keywords
- colorectal cancer, COVID 19 pandemic
- Medical subject headings
- Colonic Neoplasms, Colorectal Neoplasms, COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Colorectal resectionsProcedure or surgery
All patients admitted with colorectal cancer were subjected to various types of colorectal resections
What is being measured
The primary outcome is the main question the study is designed to answer.
Early post operative mortality
patients who died within 30 days following their surgery
Measured: 30 days
Secondary outcomes (3)
Early Post operative complications
post operative complications will be graded as per clavien dindo grading system
Measured: 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.
Measured: 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
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2020
- Study start23 Mar 2020
- Primary completion22 Sep 2020
- Study completion22 Oct 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colo-rectal CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sheri Kashmir Institute of Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, ASIF MEHRAJ, Sheri Kashmir Institute of Medical Sciences
- Investigators
- Nisar A Chowdri, Study chair, Government organisation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04588909
- Sponsor's protocol ID
- 73/2020 (Supl 2)
- Status last verified
- Oct 2020
- First submitted
- 14 Oct 2020
- Last updated
- 19 Oct 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Outcomes of Elective Colorectal Cancer Surgery During COVID 19 Pandemic: Implications for Cancer Care Policy
- ClinicalTrials.gov ID
- NCT04588909
- Acronym / sponsor ID
- 73/2020 (Supl 2)
- Conditions
- Colo-rectal Cancer
- Keywords
- colorectal cancer, COVID 19 pandemic
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Sheri Kashmir Institute of Medical SciencesUniversity, hospital or other
- Study start
- 23 Mar 2020 (actual)
- Primary completion
- 22 Sep 2020 (actual)
- Study completion
- 22 Oct 2020 (estimated)
- First posted
- 19 Oct 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All Colorectal cancer patients subjected to both elective and emergency surgery during COVID 19 pandemic.
Key inclusion criteria (1 listed)
- colorectal cancer patients subjected to surgery during COVID 19 pandemic
Key exclusion criteria (1 listed)
- SARS CoV 2 infected patients
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Colorectal resectionsAll patients admitted with colorectal cancer were subjected to various types of colorectal resections | Procedure or surgery | – |
Primary outcome
Early post operative mortality
Time frame: 30 days
patients who died within 30 days following their surgery
3 secondary outcomes
Early Post operative complications
Time frame: 30 days
Incidence of SARS CoV2 infectivity among health care providers providing direct care to involved patients
Time frame: 30 days
Rate of hospital acquired SARS CoV 2 infection among operated patients.
Time frame: 30 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nisar A Chowdri study chair
Government organisation
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Colo-rectal Cancer, run by Sheri Kashmir Institute of Medical Sciences at 1 site in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Early post operative mortality (time frame: 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Oct 2020.