| CTRI Number |
CTRI/2025/07/090947 [Registered on: 15/07/2025] Trial Registered Prospectively |
| Last Modified On: |
14/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Other |
|
Public Title of Study
|
Using CRP to Spot Early Complications After Surgery and How It is Affected by the Type of Anaesthesia Used |
|
Scientific Title of Study
|
Diagnostic accuracy of C-reactive protein as an early marker for postoperative complications and its association with anaesthesia technique |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DrKeerthana Santhosh |
| Designation |
Junior Resident |
| Affiliation |
Amala Institute of Medical Sciences |
| Address |
Department of Anaesthesiology
Amala Institue to Medical Sciences
Thrissur
Amalanagar
Thrissur
KERALA
680555
India |
| Phone |
9745628946 |
| Fax |
|
| Email |
keerthana2798@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DrSatheedevi P |
| Designation |
Professor and HOD Anaesthesiology and guide |
| Affiliation |
Amala Institute of Medical Sciences |
| Address |
Department of Anesthesiology
Amala Institute of Medical Sciences
Thrissur
Thrissur
KERALA
680555
India |
| Phone |
9447418246 |
| Fax |
|
| Email |
drsathee171@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DrBinu Puthur Simon |
| Designation |
Assistant Professor and co-guide |
| Affiliation |
Amala Institute of Medical Sciences |
| Address |
Department of Anesthesiology
Amala Institute of Medical Sciences
Thrissur
Thrissur
KERALA
680555
India |
| Phone |
8547728195 |
| Fax |
|
| Email |
binuputhursimon@gmail.com |
|
|
Source of Monetary or Material Support
|
| Amala Institute of Medical Sciences
Thrissur
Kerala
India
680555
Thrissur |
|
|
Primary Sponsor
|
| Name |
DrKeerthana Santhosh |
| Address |
Junior Resident in
Department of Anesthesiology
Amala Institute of Medical Sciences
Thrissur
Kerala
680555 |
| Type of Sponsor |
Other [Self] |
|
|
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 Keerthana Santhosh |
Amala Institute of Medical Sciences |
Department of Anaesthesiology,
Chavara Block
Amalanagar
Thrissur, Kerala
Thrissur
KERALA |
9745628946
keerthana2798@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC Amala Institute of Medical Sciences |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
Age more than 18 years
ASA grade I, II and III
Elective major abdominal surgeries
|
|
| ExclusionCriteria |
| Details |
Patients with a diagnosed chronic inflammatory disease
Patients who are diagnosed to have sepsis prior to surgery
Emergency surgery and reexploration.
Patients on anti-inflammatory drugs such as steroids
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To study the diagnostic accuracy of CRP levels as an early marker for postoperative complications, and its association with anesthesia techniques |
Preoperative CRP,
Day 3,5,7 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Evaluate the association between CRP levels and development of postoperative complications.
Evaluate the correlation between CRP levels and the anesthesia technique used (General anesthesia or General anesthesia and Epidural)
|
Post op day 3,5,7 |
|
|
Target Sample Size
|
Total Sample Size="246"
Sample Size from India="246"
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)
|
27/07/2025 |
| 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 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 prospective cohort study aims to evaluate the diagnostic accuracy of C-reactive protein ,CRP, as an early marker for postoperative complications in patients undergoing elective major abdominal surgery. The study also assesses the association between CRP levels and the type of anaesthesia technique used such as general anaesthesia alone versus general anaesthesia combined with epidural analgesia. CRP levels will be measured on postoperative days 3, 5, and 7, and complications will be graded using the Clavien-Dindo classification. The findings may help in early identification of postoperative complications and optimize perioperative care strategies |