| CTRI Number |
CTRI/2022/02/040582 [Registered on: 24/02/2022] Trial Registered Prospectively |
| Last Modified On: |
23/02/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Follow Up Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
NEUTROPHIL-TO-LYMPHOCYTE RATIO OR PLATELET INDICES, WHAT IS THE BETTER INDICATOR TO PREDICT THE SEVERITY OF ACUTE APPENDICITIS ON HISTOPATHOLOGY- AN OBSERVATIONAL STUDY |
|
Scientific Title of Study
|
COMPARISON OF NEUTROPHIL-TO-LYMPHOCYTE RATIO AND PLATELET INDICES TO PREDICT THE SEVERITY OF ACUTE APPENDICITIS ON HISTOPATHOLOGY - AN OBSERVATIONAL STUDY |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
VIMLENDRA KUMAR CHAUDHARY |
| Designation |
POST GRADUATE |
| Affiliation |
Maulana Azad Medical college, New Delhi |
| Address |
Room no. 216,BL Taneja Block, Department Of General Surgery, Lok Nayak Hospital, JLN marg, New Delhi 110002
Room no. 216,BL Taneja Block, Department Of General Surgery, Lok Nayak Hospital, JLN marg, New Delhi 110002
Central
DELHI
110002
India |
| Phone |
8860045056 |
| Fax |
|
| Email |
surgery.vimlendrakchaudhary.2020@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sushanto Neogi |
| Designation |
Professor |
| Affiliation |
Maulana Azad Medical College and associated Lok Nayak Hospital |
| Address |
Room no. 216, Department of Surgery, BL Taneja Block, Lok Nayak Hospital, New delhi
Department of Surgery, Lok Nayak Hospital, JLN marg, New Delhi-110002
New Delhi
DELHI
110002
India |
| Phone |
9968604384 |
| Fax |
|
| Email |
sushantoneogi@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Vimlendra Kumar Chaudhary |
| Designation |
POST GRADUATE |
| Affiliation |
Maulana Azad Medical College and associated Lok Nayak Hospital |
| Address |
Room no. 216,BL Taneja Block, Department Of General Surgery, Lok Nayak Hospital, JLN marg, New Delhi 110002
Room no. 216,BL Taneja Block, Department Of General Surgery, Lok Nayak Hospital, JLN marg, New Delhi 110002
New Delhi
DELHI
110002
India |
| Phone |
08860045056 |
| Fax |
|
| Email |
surgery.vimlendrakchaudhary.2020@gmail.com |
|
|
Source of Monetary or Material Support
|
| Maulana Azad Medical College |
|
|
Primary Sponsor
|
| Name |
Department of surgery |
| Address |
Lok Nayak Hospital, JLN marg, New Delhi-110002 |
| 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 Vimlendra Kumar Chaudhary |
Department of Surgery and Department of Pathology |
Room no. 216,BL Taneja Block, Department Of General Surgery, Lok Nayak Hospital, JLN marg, New Delhi 110002
Central
DELHI |
08860045056
surgery.vimlendrakchaudhary.2020@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
|
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Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K358||Other and unspecified acute appendicitis, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
Diagnosed case of Acute appendicitis with Alvarado score >7 |
|
| ExclusionCriteria |
| Details |
1.Diagnosed case of appendicular lump, perforation peritonitis.
2.Myocardial infarction.
3.Uncontrolled diabetes mellitus.
4.Autoimmune disorders.
5.Patients on immunosuppressive therapy.
6.Pregnancy and lactation.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.Neutrophil-to-lymphocyte ratio
2.Platelet indices (mean platelet volume and platelets distribution width)
3.Histopathological Finding
|
at the time of presentation which is 0 hour and after
1 week |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| 1.Duration of symptoms |
1. At the time of presentation |
|
|
Target Sample Size
|
Total Sample Size="20"
Sample Size from India="20"
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
|
Phase 2/ Phase 3 |
|
Date of First Enrollment (India)
|
28/02/2022 |
| 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 Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
As different study have suggested that both neutrophil to lymphocyte ratio and platelet indices(mean platelet volume and platelet distribution width) are the inflammatory marker and increase during inflammation. Since the positive predictive value of both these indices is different and different studies have said one to be superior to other, so we will be prospectively comparing the neutrophil-to-lymphocyte ratio (NLR) with the Platelets indices by applying both to patient who presented to accident & emergency department and are diagnosed of acute appendicitis to prove which is the superior marker for predicting severity of appendicitis. this study is being done to compare neutrophil to lymphocyte ration and platelet indices to predict the severity of acute appendicitis on histopathology. |