| CTRI Number |
CTRI/2021/06/034184 [Registered on: 11/06/2021] Trial Registered Prospectively |
| Last Modified On: |
10/06/2021 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Other |
|
Public Title of Study
|
cardiovascular complications in oncosurgeries- incidence and risk factors |
|
Scientific Title of Study
|
The incidence and risk factors for cardiovascular complications after oncosurgeries: A retrospective analysis |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
rajasree o |
| Designation |
Associate Professor |
| Affiliation |
Regional Cancer Centre |
| Address |
Department of Anaesthesiology
Regional Cancer centre, Thiruvananthapuram
Thiruvananthapuram
KERALA
695011
India |
| Phone |
9446514376 |
| Fax |
|
| Email |
rajasreesajan@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
rajasree o |
| Designation |
Associate Professor |
| Affiliation |
Regional Cancer Centre |
| Address |
Department of Anaesthesiology
Regional Cancer centre, Thiruvananthapuram
Thiruvananthapuram
KERALA
695011
India |
| Phone |
9446514376 |
| Fax |
|
| Email |
rajasreesajan@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
rajasree o |
| Designation |
Associate Professor |
| Affiliation |
Regional Cancer Centre |
| Address |
Department of Anaesthesiology
Regional Cancer centre, Thiruvananthapuram
Thiruvananthapuram
KERALA
695011
India |
| Phone |
9446514376 |
| Fax |
|
| Email |
rajasreesajan@gmail.com |
|
|
Source of Monetary or Material Support
|
| Regional Cancer Centre, Thiruvananthapuram |
|
|
Primary Sponsor
|
| Name |
Regional Cancer Centre |
| Address |
Medical college campus
Medical college P O
Thiruvananthapuram-695011 |
| Type of Sponsor |
Government medical college |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Rajasree O |
Regional Cancer Centre |
Department of Anaesthesiology,Regional Cancer Centre, Medical college P O, Thiruvananthapuram.
Thiruvananthapuram
KERALA |
9446514376
rajasreesajan@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Scientific review committe, Institutional Review Board, Regional Cancer Centre, Thiruvananthapuram |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: I219||Acute myocardial infarction, unspecified, (2) ICD-10 Condition: I238||Other current complications following acute myocardial infarction, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Both |
| Details |
All postoperative patients above 18 yrs |
|
| ExclusionCriteria |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| incidence of cardiovascular complications after oncosurgeries during first thirty days postoperative period. The risk factors associated with these cardiovascular complications |
4 weeks (30 days) after surgery |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To measure the incidence of electrolyte imbalances and association to cardiac events. |
within 30 days (4 weeks) after surgery. |
|
|
Target Sample Size
|
Total Sample Size="200"
Sample Size from India="200"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
15/06/2021 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Postoperative cardiac complications
are major cause of morbidity and mortality in onco surgeries. Since malignancy
is a prothrombotic state the risk
of thrombotic events such as DVT
(1),pulmonary embolisms and MI are high in these patients.Oncologic patients
are more prone for nutritional deficiency and cancer cachexia leading multiple
electrolyte imbalances.Age >75 yrs associated with increased risk of cardiac
complications (2) Postoperative arrhythmias are frequent cause of morbidity
with atrial fibrillation and QT prolongation having specific relevance to the
peri operative period.(3) AIM To estimate the incidence of
postoperative cardiovascular complications following major cancer surgeries and
to identify associated risk factors. OBJECTIVES
â—
Primary
objective -To find out the
association with various risk factors and post op cardiac events.
â—
Secondary
objective - To measure the incidence of electrolyte imbalances and association to
cardiac events. METHODS â—
Study setting Department of
Anaesthesiology, Regional Cancer Center, Thiruvananthapuram. â—
Study
population Inclusion
criteria:All
postoperative patients above 18 yrs Exclusion criteria:Age below 18 yrs â—
Methodology
Study will be
conducted over a period of one year by reviewing the records.
Patients will be selected on basis of inclusion and exclusion criteria. â—
Statistical
analysis
The χ 2 test
or Fisher’s exact test will be used to compare the distribution of categoric
variables, the Student t test will be used to compare continuous variables, and
the Kruskal-Wallis nonparametric test will be used for comparison of data that
did not obey a normal distribution.
The confidence
intervals (CI) of the cumulative incidence of observed cardiac complications
will be calculated using a binomial approach. The adjusted contribution of the different risk
factors will be estimated by Poisson regression. REFERENCES
1. Khushal A, Quinlan D, Alikhan R, Gardner
J, Bailey C, Cohen A. Thromboembolic disease in surgery for
malignancy-rationale for prolonged thromboprophylaxis. Semin Thromb Hemost.
2002 Dec;28(6):569-76. doi: 10.1055/s-2002-36701. PMID: 12536350. 2. Joan
Puig-Barberà , Soledad Márquez-Calderón, Miguel
Vila-Sánchez. Cardiac Complications of Major Elective Non-Cardiac Surgery:
Incidence and Risk Factors.
3. D. Sellers, C. Srinivas,
G. Djaiani. Cardiovascular complications after non-cardiac surgery. Anaesthesia
2018, 73 (Suppl. 1), 34–42.
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