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CTRI Number  CTRI/2024/03/064097 [Registered on: 13/03/2024] Trial Registered Prospectively
Last Modified On: 05/11/2024
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cohort Study 
Study Design  Other 
Public Title of Study   Comparison of pathological scoring systems in cases of acute appendicitis. 
Scientific Title of Study   To compare diagnostic efficacy of fenyo lindberg scoring sysytem and yash scoring system in patients of acute 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  Dr Eeda Srinivasa Reddy 
Designation  Junior Resident 
Affiliation  Datta Meghe Institute of Higher Education And Research 
Address  Department of General Surgery, Acharya Vinobha Bhave Rural Hospital, JawaharLal Nehru Medical College, DMIHER, Sawangi Meghe, Wardha 442004, Maharashtra, India

Wardha
MAHARASHTRA
442004
India 
Phone  8861769686  
Fax    
Email  esrreddy90@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Darshana Tote 
Designation  Professor 
Affiliation  Datta Meghe Institute of Higher Education And Research 
Address  Department of General Surgery, Acharya Vinobha Bhave Rural Hospital, JawaharLal Nehru Medical College, DMIHER, Sawangi Meghe, Wardha 442004, Maharashtra, India

Wardha
MAHARASHTRA
442004
India 
Phone  9923129974  
Fax    
Email  drtotedarshana@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Eeda Srinivasa Reddy 
Designation  Junior Resident 
Affiliation  Datta Meghe Institute of Higher Education And Research 
Address  Department of General Surgery, Acharya Vinobha Bhave Rural Hospital, JawaharLal Nehru Medical College, DMIHER, Sawangi Meghe, Wardha 442004, Maharashtra, India

Wardha
MAHARASHTRA
442004
India 
Phone  8861769686  
Fax    
Email  esrreddy90@gmail.com  
 
Source of Monetary or Material Support  
Dattta Meghe Institute Of Higher Education And Research,SAWANGI MEGHE, Wardha 
 
Primary Sponsor  
Name  Eeda Srinivasa Reddy  
Address  Department of General Surgery, Acharya Vinobha Bhave Rural Hospital, JawaharLal Nehru Medical College, DMIHER, Sawangi Meghe, Wardha 442004, Maharashtra, India 
Type of Sponsor  Other [SELF] 
 
Details of Secondary Sponsor  
Name  Address 
nil  nil 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
DR EEDA SRINIVASA REDDY  Acharya Vinobha Bhave Rural Hospital, Wardha  Department Of General Surgery, AVBRH Hospital, JawaharLal Nehru Medical College, DMIHER, Sawangi Meghe, Wardha 442004, India
Wardha
MAHARASHTRA 
8861769686

esrreddy90@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTIONAL ETHICS COMMITTEE Re-regd. No.: ECR/440/InsUMH/2013/RR-2019 Sawangi (Meghe), Wardha-442 107, Maharashtra, India  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
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 
Comparator Agent  nil  nil 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Male 
Details  1.Patients clinically diagnosed with acute appendicitis.
2.All age groups and both sexes will be considered.
3.Patients are willing and provide consent for surgery.
 
 
ExclusionCriteria 
Details  1.Patients diagnosed with Appendicular perforation, peritonitis, appendicular mass, or appendicular abscess.
2.Patients diagnosed with appendicitis who have a confirmed history of connective tissue dysfunction.
3.Pregnant women.
4.Patients who are unfit or unwilling for surgery or have an unsound mind.
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
The primary outcome of this study is focusing on which scoring sysytem demonstartes the superior accuracy in diagnosing acute appendicitis.  2 Years 
 
Secondary Outcome  
Outcome  TimePoints 
1.Diagnostic performance of individual scoring components.
2.comparison of specificity and sensitivity 
2 years 
 
Target Sample Size   Total Sample Size="95"
Sample Size from India="95" 
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)   22/03/2024 
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="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Applicable 
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  

Acute appendicitis is a typical surgical emergency, and accurate diagnosis is pivotal for timely and appropriate clinical management . This study protocol aims to prospectively compare the diagnostic efficacy of the Yash scoring system and the Fenyo-Lindberg scoring system in cases of acute appendicitis, shedding light on their respective roles in clinical practice.

With its comprehensive inclusion of clinical parameters and imaging results, the Yash scoring system has been advocated for its potential to enhance diagnostic accuracy . In contrast, the Fenyo-Lindberg scoring system focuses on clinical features, prioritizing simplicity in its approach . This study’s intention to compare these two scoring systems aligns with the need for evidence-based approaches to acute appendicitis diagnosis.

Our findings will contribute to the ongoing discourse on refining diagnostic strategies for acute appendicitis. A study by Yash et al. demonstrated the utility of their scoring system in a specific population. The comparative aspect of our research will offer a broader perspective, potentially identifying nuances in diagnostic performance across diverse patient groups.

However, this study has its limitations. The reliance on a single tertiary care hospital may limit the generalizability of our findings to other settings. Additionally, the study’s observational nature may introduce biases despite rigorous methodology. The potential impact of confounding variables, such as variations in disease presentation among different age groups, needs careful consideration during data analysis.

Considering these limitations, future research could explore the external validation of the identified scoring systems in different healthcare settings and patient populations. Furthermore, a long-term followup could assess the clinical outcomes of the diagnostic decisions guided by these scoring systems. 
 
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