| CTRI Number |
CTRI/2024/05/067324 [Registered on: 14/05/2024] Trial Registered Prospectively |
| Last Modified On: |
10/12/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Follow Up Study |
| Study Design |
Other |
|
Public Title of Study
|
Role of Platelet values and ratio of WBC components as indicators to differentiate between types of appendicitis |
|
Scientific Title of Study
|
Role of Platelet indices and Neutrophil-Lymphocyte Ratio as biomarkers to differentiate between complicated and uncomplicated appendicitis |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Divyanshu P Aggarwal |
| Designation |
Junior Resident |
| Affiliation |
Kasturba Medical College and Hospital, Manipal |
| Address |
3rd floor, Smt. Sharada Madhav Pai, OPD building, Kasturba Hospital, Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
9717828296 |
| Fax |
|
| Email |
divaggarwal.7@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Pavan Madhukar Bhat |
| Designation |
Assistant Professor |
| Affiliation |
Kasturba Medical College and Hospital, Manipal |
| Address |
3rd floor, Smt. Sharada Madhav Pai, OPD building, Kasturba Hospital, Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
9731243720 |
| Fax |
|
| Email |
pavan.bhat@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Pavan Madhukar Bhat |
| Designation |
Assistant Professor |
| Affiliation |
Kasturba Medical College and Hospital, Manipal |
| Address |
3rd floor, Smt. Sharada Madhav Pai, OPD building, Kasturba Hospital, Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
9731243720 |
| Fax |
|
| Email |
pavan.bhat@manipal.edu |
|
|
Source of Monetary or Material Support
|
| Kasturba Medical College and Hospital, Manipal, Udupi, Karnataka - 576104 |
|
|
Primary Sponsor
|
| Name |
Kasturba Medical College Manipal |
| Address |
3rd floor, Smt. Sharada Madhav Pai,OPD building, Kasturba Hospital,Manipal,Udupi,Karnataka-576104 |
| 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 Divyanshu P Aggarwal |
Kasturba Hospital |
Department of General Surgery, 3rd floor, Smt. Sharada Madhav Pai, OPD building, Kasturba Hospital, Manipal
Udupi
KARNATAKA |
9717828296
divaggarwal.7@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Kasturba Medical College and Kasturba Hospital Institutional Ethics Committee - 2 (Student Research) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K35||Acute appendicitis, |
|
|
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 |
• Diagnosed case of acute appendicitis with help of USG/ CECT/ MRI
• Patient undergoing upfront acute appendectomy
• Conservatively managed cases of acute appendicitis
• Patient consenting to be a part of the study. |
|
| ExclusionCriteria |
| Details |
1) Patient not willing to participate in the study
2) Patient undergoing interval appendectomy surgery.
3) Cases of other infective foci- clinically
4) Appendicular tumors with appendicitis
5) Chronic inflammatory conditions
6) Autoimmune diseases
7) Immunosuppression
8) Malignancy
9) Pregnancy |
|
|
Method of Generating Random Sequence
|
|
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
Cut-off values for Platelet Distribution Width, Mean Platelet Volume and Neutrophil-Lymphocyte Ratio to indicate higher risk of complicated appendicitis
|
At admission
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Surgical versus Conservative management
|
From date of present admission till discharge |
Length of stay
|
From date of present admission till discharge |
| In hospital Complications |
From date of present admission till discharge |
|
|
Target Sample Size
|
Total Sample Size="106"
Sample Size from India="106"
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)
|
22/05/2024 |
| 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="9"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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
|
After ethics committee clearance is obtained, patients diagnosed as cases of acute appendicitis with the help of USG/CECT/MRI shall be identified. The patients undergoing upfront acute appendectomy, conservative management or other interventions that fulfil the inclusion and exclusion criteria will be approached. Participant Information Sheet will be handed over to the participant. Informed consent will be taken. In each patient, blood sample routinely sent at admission for Complete Blood Count will be noted and parameters like PDW, MPV and total and differential counts as well as NLR calculated henceforth analyzed in the context of their clinical and radiological picture in terms of complicated vs uncomplicated appendicitis as well as the management under gone by them. Their course in the hospital until discharge will be monitored including length of stay as well as any in hospital complications. Proforma will be filled for each patient and data will be collected and analyzed. |