Comorbidities and Coexisting ConditionsoncosurgeryNCT05038501
Prevalence of Comorbidities in Patients Undergoing Oncosurgeries at Tertiary Cancer Institute in North India.
An observational study of Comorbidities and Coexisting Conditions, run by Rajiv Gandhi Cancer Institute & Research Center, India at 1 site in India.
Trial summary
Investigators plan to study the prevalence of comorbidities in patients undergoing oncosurgeries Read more about this study
- Who is it for?
- Ages 35 to 80 years
- Conditions the study is for
- Comorbidities and Coexisting Conditions
- What is being tested?
- To study comorbidities in patients undergoing Oncosurgeries
- How many people
- 150 participants
- Where
- 1 siteIndia
- Study dates
- 1 Jul 2021to 31 Aug 2021
- 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 35 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients undergoing Oncosurgeries will be studied for prevalence of comorbidites.
Who may be able to join
None listed.
Who cannot join
- Age below 40 years Emergency Surgery Patient Refusal
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prevalence of Comorbidities in Patients Undergoing Oncosurgeries at Tertiary Cancer Institute in North India
Investigators plan to study the prevalence of comorbidities in patients undergoing oncosurgeries
Read the detailed description
Plan to study the prevalence of Coronary Artery Disease, Hypertension, Diabetes Mellitus, Hypothyroidism, History of Corona Virus infection in patients undergoing oncosurgeries.
In the Pre anesthesia checkup patients age , sex , Weight in kilograms, Height in centimeters , pulse rate, Blood Pressure will be noted and value>140/90 mmHg will be taken as hypertensive. History will be obtained about diagnosed Coronary Artery Disease , Diabetes Mellitus, Hypertension , Hypothyroidism , History of previous Corona Virus Infection (RT-PCR Test Positive) .Relevant investigations Electrocardiography and Echocardiography for assessment of Coronary Artery Disease. Fasting or Random Blood Sugar , Thyroid Function Test will be done .
Fasting Blood Sugar >126 milligram/ Decilitre and Random Blood sugar >200mg/dL will be taken as diabetic. TSH more than 5 micro IU/mL will be hypothyroid .
- Conditions
- Comorbidities and Coexisting Conditions
- Being tested
- To study comorbidities in patients undergoing Oncosurgeries
- Keywords
- comorbidities, oncosurgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
To study comorbidities in patients undergoing OncosurgeriesOther
In the Preoperative Anaesthesia checkup we will study prevalence of comorbidities as Coronary artery Disease, Hypertension, Diabetes Mellitus , Hypothyroidism and prior Corona Virus Infection in patients undergoing Oncosurgeries
| Study group | Role | What they receive |
|---|---|---|
| Comorbidities in Oncosurgery patients | Prevalence of comorbidities as Coronary artery disease, Hypertension , Diabetes Mellitus,Hypothyroidism and Corona Virus Infection will be studied in patients undergoing Oncosurgeries. Receives: Other: To study comorbidities in patients undergoing Oncosurgeries |
What is being measured
The primary outcome is the main question the study is designed to answer.
To study Coronary Artery disease in patients undergoing Oncosurgeries
Electrocardiography and Echocardiography will be performed.
Investigators will measure Blood Pressure , Blood Sugar , Thyroid Function Test and previous Corona Virus Infection
Measured: 60 days
To study Diabetes Mellitus in patients undergoing Oncosurgeries.
Random Blood Sugar in milligram/Decilitre will be measured.
Measured: 60days
Secondary outcomes (1)
To study Hypothyroidism in patients undergoing Oncosurgeries
Thyroid Stimulating Hormone (TSH) in micro IU / millilitre will be measured.
Measured: 60 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2021
- Study start1 Jul 2021
- Primary completion31 Aug 2021
- Study completion31 Aug 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Comorbidities and Coexisting ConditionsStudies 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
- Other
- Time perspective
- Retrospective
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rajiv Gandhi Cancer Institute & Research Center, India
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr Anita Kulkarni, Rajiv Gandhi Cancer Institute & Research Center, India
- Investigators
- Anita Kulkarni, MD, Principal investigator, Rajiv Gandhi Cancer Institute and RC , Delhi, INDIA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05038501
- Sponsor's protocol ID
- RGCI \ MK 1967
- Acronym
- oncosurgery
- Status last verified
- Oct 2021
- First submitted
- 15 Aug 2021
- Last updated
- 4 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Gupta R, Mohan I, Narula J. Trends in Coronary Heart Disease Epidemiology in India. Ann Glob Health. 2016 Mar-Apr;82(2):307-15. doi: 10.1016/j.aogh.2016.04.002.
PubMed 27372534Ranasinghe P, Jayawardena R, Gamage N, Sivanandam N, Misra A. Prevalence and trends of the diabetes epidemic in urban and rural India: A pooled systematic review and meta-analysis of 1.7 million adults. Ann Epidemiol. 2021 Jun;58:128-148. doi: 10.1016/j.annepidem.2021.02.016. Epub 2021 Mar 13.
PubMed 33727086
Study at a glance
From the registry record, last updated by the sponsor on 4 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevalence of Comorbidities in Patients Undergoing Oncosurgeries at Tertiary Cancer Institute in North India
- ClinicalTrials.gov ID
- NCT05038501
- Acronym / sponsor ID
- oncosurgery / RGCI \ MK 1967
- Conditions
- Comorbidities and Coexisting Conditions
- Keywords
- comorbidities, oncosurgery
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Rajiv Gandhi Cancer Institute & Research Center, IndiaUniversity, hospital or other
- Study start
- 1 Jul 2021 (actual)
- Primary completion
- 31 Aug 2021 (actual)
- Study completion
- 31 Aug 2021 (actual)
- First posted
- 9 Sep 2021 (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.
Investigators plan to study the prevalence of comorbidities in patients undergoing oncosurgeries
Detailed description
Plan to study the prevalence of Coronary Artery Disease, Hypertension, Diabetes Mellitus, Hypothyroidism, History of Corona Virus infection in patients undergoing oncosurgeries.
In the Pre anesthesia checkup patients age , sex , Weight in kilograms, Height in centimeters , pulse rate, Blood Pressure will be noted and value>140/90 mmHg will be taken as hypertensive. History will be obtained about diagnosed Coronary Artery Disease , Diabetes Mellitus, Hypertension , Hypothyroidism , History of previous Corona Virus Infection (RT-PCR Test Positive) .Relevant investigations Electrocardiography and Echocardiography for assessment of Coronary Artery Disease. Fasting or Random Blood Sugar , Thyroid Function Test will be done .
Fasting Blood Sugar >126 milligram/ Decilitre and Random Blood sugar >200mg/dL will be taken as diabetic. TSH more than 5 micro IU/mL will be hypothyroid .
Study design
- Observational model
- Other
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Comorbidities in Oncosurgery patients | – | Other: To study comorbidities in patients undergoing OncosurgeriesPrevalence of comorbidities as Coronary artery disease, Hypertension , Diabetes Mellitus,Hypothyroidism and Corona Virus Infection will be studied in patients undergoing Oncosurgeries. |
Who may qualify
- Ages
- 35 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients undergoing Oncosurgeries will be studied for prevalence of comorbidites.
Key inclusion criteria (0 listed)
Key exclusion criteria (1 listed)
- Age below 40 years Emergency Surgery Patient Refusal
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 |
|---|---|---|
| To study comorbidities in patients undergoing OncosurgeriesIn the Preoperative Anaesthesia checkup we will study prevalence of comorbidities as Coronary artery Disease, Hypertension, Diabetes Mellitus , Hypothyroidism and prior Corona Virus Infection in patients undergoing Oncosurgeries | Other | Comorbidities in Oncosurgery patients |
Primary outcome
To study Coronary Artery disease in patients undergoing Oncosurgeries
Time frame: 60 days
Electrocardiography and Echocardiography will be performed. Investigators will measure Blood Pressure , Blood Sugar , Thyroid Function Test and previous Corona Virus Infection
To study Diabetes Mellitus in patients undergoing Oncosurgeries.
Time frame: 60days
Random Blood Sugar in milligram/Decilitre will be measured.
1 secondary outcome
To study Hypothyroidism in patients undergoing Oncosurgeries
Time frame: 60 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Oct 2021.
- Background: PubMed 27372534Gupta R, Mohan I, Narula J. Trends in Coronary Heart Disease Epidemiology in India. Ann Glob Health. 2016 Mar-Apr;82(2):307-15. doi: 10.1016/j.aogh.2016.04.002.
- Background: PubMed 33727086Ranasinghe P, Jayawardena R, Gamage N, Sivanandam N, Misra A. Prevalence and trends of the diabetes epidemic in urban and rural India: A pooled systematic review and meta-analysis of 1.7 million adults. Ann Epidemiol. 2021 Jun;58:128-148. doi: 10.1016/j.annepidem.2021.02.016. Epub 2021 Mar 13.
- Individual participant dataSharing planned: No
Related trials for Comorbidities and Coexisting Conditions
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
RecruitingPhase 2/3
Evaluating Smoking Cessation Interventions for PWH in South Africa
Smoking Cessation, HIV
RecruitingObservational study
Frailty in Outpatient Digestive Endoscopy
Frailty, Comorbidities and Coexisting Conditions
Recruiting
eCardiacRehab - a Hybrid Patient-Centered eHealth Programme
Comorbidities and Coexisting Conditions, Ethics
Active, not recruiting
Digital Implementation of the German S3 Clinical Practice Guideline for Multimorbidity
Asthma Bronchiale, Breast Neoplasms
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.
Anita Kulkarni, MD principal investigator
Rajiv Gandhi Cancer Institute and RC , Delhi, INDIA
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 Comorbidities and Coexisting Conditions, run by Rajiv Gandhi Cancer Institute & Research Center, India 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 0 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: finished, as of the sponsor's last update on 4 Oct 2021. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
To study Coronary Artery disease in patients undergoing Oncosurgeries (time frame: 60 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05038501, which also lists 2 linked publications.
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 4 Oct 2021.