| 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
|
|
|
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
|
|
|
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. |