| CTRI Number |
CTRI/2024/09/073650 [Registered on: 09/09/2024] Trial Registered Prospectively |
| Last Modified On: |
27/08/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Other |
|
Public Title of Study
|
Predictions of complications arising after major abdominal surgeries by assessing laboratory parameters. |
|
Scientific Title of Study
|
Diagnostic value of post operative C Reactive Protein (CRP) to Albumin ratio (CAR) for predicting complications after major abdominal surgeries |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr SHYAM SUNDAR P |
| Designation |
Associate professor |
| Affiliation |
Amrita Institute of Medical Sciences , Kochi |
| Address |
Department of Anaesthesiology and Critical Care
Amrita Institute of Medical Sciences
Ponnekara PO
Kochi
Ernakulam
KERALA
682041
India |
| Phone |
04842856162 |
| Fax |
04842802020 |
| Email |
pssundar@rediffmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr SHYAM SUNDAR P |
| Designation |
Associate professor |
| Affiliation |
Amrita Institute of Medical Sciences , Kochi |
| Address |
Department of Anaesthesiology and Critical Care
Amrita Institute of Medical Sciences
Ponnekara PO
Kochi
Ernakulam
KERALA
682041
India |
| Phone |
04842856162 |
| Fax |
04842802020 |
| Email |
pssundar@rediffmail.com |
|
Details of Contact Person
Public Query
|
| Name |
MINNUMOL THOMAS |
| Designation |
post graduate -Junior resident |
| Affiliation |
Amrita Institute of Medical Sciences , Kochi |
| Address |
Department of Anaesthesiology and Critical Care
Amrita Institute of Medical Sciences
Ponnekara PO
Kochi
Ernakulam
KERALA
682041
India |
| Phone |
04842856162 |
| Fax |
04842802020 |
| Email |
minnumolthomas@yahoo.in |
|
|
Source of Monetary or Material Support
|
| Amrita Institute of Medical sciences
Ponekkara PO
Kochi
Kerala , India
PIN 682041
Phone 04842856162
|
|
|
Primary Sponsor
|
| Name |
Amrita Institute of Medical Sciences |
| Address |
Amrita Institute of Medical Sciences
Ponnekkara P.O
Kochi
Kerala
pin: 682041 |
| Type of Sponsor |
Private 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 Minnumol Thomas |
Amrita Institute of Medical Sciences |
Department of Anesthesia and Critical care unit,
Ponekkara PO
Kochi
PIN 682041
Ernakulam
KERALA |
9400024666
minnumolthomas@yahoo.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethics Committee of Amrita School of Medicine |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: R190||Intra-abdominal and pelvic swelling, mass and lump, (2) ICD-10 Condition: R00-R99||Symptoms, signs and abnormal clinical and laboratory findings, not elsewhere classified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
- Duration of surgery for more than 3 hours
- ASA 1 , 2, 3
-Elective Surgeries |
|
| ExclusionCriteria |
| Details |
1.Patients getting discharged within 48hrs after surgery
2.Incomplete laboratory data
3.patients getting albumin infusion within two post operative days
4.patient getting reoperated prior to POD 3
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To evaluate association between CRP/Albumin ratio and post operative length of ICU stay. |
CRP/Albumin levels will be noted preoperatively and on POD day 3 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. To evaluate association between CRP/Albumin ratio and post operative surgical site infection.
2. To evaluate association between CRP/Albumin ratio to post operative complications as per Clavein Dindo classification. |
-CRP/Albumin levels noted preoperatively and on POD day 3.
- post op complications will be assessed till POD 30 |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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)
|
01/10/2024 |
| 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="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This is a prospective Cohort study in which we assess the CRP to albumin ratio pre operatively and on POD 3, to determine its association towards predicting post operative complications in major abdominal surgeries .Post operative complications will be assessed based on the total post operative length of ICU stay , grading as per Clavein Dindo classification and Surgical site infections. At the end of the study the collected data will be analyzed statistically. |