| CTRI Number |
CTRI/2025/02/081242 [Registered on: 24/02/2025] Trial Registered Prospectively |
| Last Modified On: |
22/02/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Prospective observational study |
| Study Design |
Other |
|
Public Title of Study
|
Evaluating the Use of a Smartphone Application for Diagnosing Appendicitis in Patients Aged between 10 to 65 years to Predict Surgical Decision Making and Enhance Patient Outcomes |
|
Scientific Title of Study
|
Development of a smart phone application for patients with appendicular pathology to assess severity mitigate complications and predict surgical intervention |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Prasna S |
| Designation |
Post Graduate, General Surgery |
| Affiliation |
Saveetha Medical College and Hospital |
| Address |
2nd floor, Department of General Surgery, Saveetha Medical College and Hospital, Saveetha Nagar, Thandalam,
Chennai
Chennai
TAMIL NADU
602105
India |
| Phone |
9582299096 |
| Fax |
|
| Email |
sprasna7@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
B S Sundaravadanan |
| Designation |
Professor, General Surgery |
| Affiliation |
Saveetha Medical College and Hospital |
| Address |
2nd floor, Department of General Surgery, Saveetha Medical College and Hospital, Saveetha Nagar, Thandalam,
Chennai
Chennai
TAMIL NADU
602105
India |
| Phone |
9841073832 |
| Fax |
|
| Email |
surgeonsundar@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Prasna S |
| Designation |
Post Graduate, General Surgery |
| Affiliation |
Saveetha Medical College and Hospital |
| Address |
2nd floor, Department of General Surgery, Saveetha Medical College and Hospital, Saveetha Nagar, Thandalam,
Chennai
Chennai
TAMIL NADU
602105
India |
| Phone |
9582299096 |
| Fax |
|
| Email |
sprasna7@gmail.com |
|
|
Source of Monetary or Material Support
|
| Saveetha Medical College and Hospital, Saveetha Nagar, Thandalam, Chennai- 602105 |
|
|
Primary Sponsor
|
| Name |
Dr. Prasna S |
| Address |
Saveetha Medical College and Hospital, Saveetha Nagar, Thandalam, Chennai- 602105 |
| 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 |
| Prasna S |
Saveetha Medical College and Hospital |
Department of General Surgery, Saveetha Medical College and Hospital, Saveetha Nagar, Thandalam, Chennai-602105
Chennai
TAMIL NADU |
9582299096
sprasna7@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Saveetha Medical College and Hospital Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K35-K38||Diseases of appendix, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
10.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Patients who are willing to undergo the study. Suspected patients with Appendicitis coming to ER/ OP.
|
|
| ExclusionCriteria |
| Details |
Patients who are not willing to undergo the study. Patients with severe hemodynamic instability.
|
|
|
Method of Generating Random Sequence
|
|
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
| The effectiveness of the smartphone application in accurately predicting the appropriate treatment plan (surgical vs. conservative management) for patients with suspected appendicitis, as determined by the scoring system integrated into the app. |
At Baseline |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Reduction in the time taken to make clinical decisions regarding appendicitis treatment.
Decrease in the incidence of complications (e.g., perforation, abscess, peritonitis) due to timely intervention based on app recommendations. |
6 weeks |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
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)
|
05/03/2025 |
| 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="1"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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 research aims to develop a smartphone application that helps in assessing the severity of appendicitis, guiding healthcare professionals toward appropriate treatment plans, and reducing complications or unnecessary surgeries. By incorporating a new scoring system based on clinical symptoms, signs, and radiological findings, the app will provide a quick and efficient decision-making tool for surgeons. The study will focus on suspected appendicitis patients in an emergency setting, using a prospective observational design to evaluate the app’s effectiveness in improving patient outcomes and optimizing management decisions. |