| CTRI Number |
CTRI/2025/08/093062 [Registered on: 14/08/2025] Trial Registered Prospectively |
| Last Modified On: |
19/10/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Follow Up Study |
| Study Design |
Other |
|
Public Title of Study
|
Comparing Two Scoring Methods to Diagnose Appendicitis in Adults |
|
Scientific Title of Study
|
A prospective observational comparative study between Adult Appendicitis Score and Modified Alvarado Score in the diagnosis 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 Devansh Bhambri |
| Designation |
Junior Resident |
| Affiliation |
Kasturba Medical College, Manipal |
| Address |
Department of General Surgery, 3rd floor, Smt. Sharada Madhav Pai OPD, Kasturba Hospital, Manipal
Udupi KARNATAKA 576104 India |
| Phone |
7837473068 |
| Fax |
|
| Email |
devansh.kmcmpl2024@learner.manipal.edu |
|
Details of Contact Person Scientific Query
|
| Name |
Dr K Rajgopal Shenoy |
| Designation |
Professor and Head of Unit |
| Affiliation |
Kasturba Medical College, Manipal |
| Address |
Department of General Surgery, 3rd floor, Smt. Sharada Madhav Pai OPD, Kasturba Hospital, Manipal
Udupi KARNATAKA 576104 India |
| Phone |
9845243460 |
| Fax |
|
| Email |
rajgopal.shenoy@manipal.edu |
|
Details of Contact Person Public Query
|
| Name |
Dr Pavan M Bhat |
| Designation |
Assistant Professor |
| Affiliation |
Kasturba Medical College, Manipal |
| Address |
Department of General Surgery, 3rd floor, Smt. Sharada Madhav Pai OPD, 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, India 576104 |
|
|
Primary Sponsor
|
| Name |
Dr Devansh Bhambri |
| Address |
Department of General Surgery, 3rd Floor, Smt. Sharada Madhav Pai OPD, Kasturba Hospital, Manipal, Udupi, Karnataka, India 576104 |
| 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 Devansh Bhambri |
Kasturba Medical College and Hospital |
Room no 8, Department of General Surgery, 3rd floor, Smt. Sharada Madhav Pai OPD, Kasturba Hospital, Manipal Udupi KARNATAKA |
7837473068
devansh.kmcmpl2024@learner.manipal.edu |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Kasturba Medical College and Kasturba Hospital Institutional Ethics Committee - 2 |
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 |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
All patients clinically diagnosed with acute appendicitis undergoing open or laparoscopic appendectomy with histopathological confirmation of diagnosis in the same admission |
|
| ExclusionCriteria |
| Details |
Patients less than 18 years of age
Patients with appendicular mass formation
Patients for whom C-reactive protein(CRP) is not sent as a consultant specific protocol |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To assess the sensitivity and specificity of both scores in diagnosing Acute Appendicitis |
At baseline |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To assess & compare the positive predictive value & negative predictive value of both scores |
At baseline |
|
|
Target Sample Size
|
Total Sample Size="53" Sample Size from India="53"
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)
|
25/08/2025 |
| 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="10" 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
|
The study is a prospective observational study that will be conducted in the General Surgery Department of Kasturba Hospital, Manipal. The study needs to be approved by the Institutional Ethics Committee. Informed consent will be taken from the participants at the time of enrolment on IP basis in the ward/triage. Study population will include patients clinically diagnosed with acute appendicitis, undergoing laparoscopic or open appendicectomy with histopathological confirmation of diagnosis. The patient will be evaluated with history and clinical examination. The routine blood investigations that will be sent before surgery will be analyzed. Thereafter, both Modified Alvarado Score and Adult Appendicitis Score will be applied on these findings and probability of having acute appendicitis will be calculated. Post operatively, the specimen will be sent for histopathological examination. Final diagnosis will be based on histopathology report. The sensitivity, specificity, PPV and NPV of both the scoring systems will be calculated and compared. |