| CTRI Number |
CTRI/2020/06/025831 [Registered on: 12/06/2020] Trial Registered Prospectively |
| Last Modified On: |
12/06/2020 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Diagnostic Accuracy Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
RIPASA, AIR and MASS Scoring Systems In Acute Appendicitis |
|
Scientific Title of Study
|
Evaluation of Alvarado scoring, RIPASA scoring and AIR scoring systems in acute appendicitis |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Meer M Chisthi |
| Designation |
Associate Professor |
| Affiliation |
Government Medical College, Thiruvananthapuram. |
| Address |
Department of General Surgery, Government Medical College, Thiruvananthapuram.
Thiruvananthapuram
KERALA
695011
India |
| Phone |
|
| Fax |
|
| Email |
meerchisthi@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Meer M Chisthi |
| Designation |
Associate Professor |
| Affiliation |
Government Medical College, Thiruvananthapuram. |
| Address |
Department of General Surgery, Government Medical College, Thiruvananthapuram.
KERALA
695011
India |
| Phone |
|
| Fax |
|
| Email |
meerchisthi@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Meer M Chisthi |
| Designation |
Associate Professor |
| Affiliation |
Government Medical College, Thiruvananthapuram. |
| Address |
Department of General Surgery, Government Medical College, Thiruvananthapuram.
KERALA
695011
India |
| Phone |
|
| Fax |
|
| Email |
meerchisthi@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Government Medical College |
| Address |
Thiruvananthapuram |
| 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 |
| Meer M Chisthi |
Government Medical College |
General Surgery department
Thiruvananthapuram
KERALA |
9446560110
meerchisthi@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Human Ethics Committee |
Approved |
|
|
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 |
12.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Both |
| Details |
Patients undergoing emergency appendicectomy for suspected appendicitis, defined as acute (1 week or less) non traumatic right iliac fossa pain consistent with a diagnosis of appendicitis (pain associated with nausea, anorexia, vomiting and fever along with clinical signs as tenderness and rebound tenderness in right iliac fossa, with or without ultrasound findings suggestive of appendicitis) |
|
| ExclusionCriteria |
| Details |
Pregnant females, patients with a right iliac fossa mass, patients with a previous history of urolithiasis or pelvic inflammatory disease, |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
| Estimate the predictive accuracy of Alvarado score and AIR score and RIPASA score against the reference standard of histopathology in patients undergoing emergency Appendicectomy |
4 weeks after appendicectomy |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Find correlation between RIPASA, AIR and MASS |
4 weeks after surgery |
|
|
Target Sample Size
|
Total Sample Size="107"
Sample Size from India="107"
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)
|
15/06/2020 |
| 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)?
|
|
Brief Summary
|
This is a Diagnostic
Accuracy study which was carried out on 107 studies to find the predictive
accuracy of Modified Alvarado Scoring System
(MASS) and two new systems namely Appendicitis Inflammatory Response (AIR)
score and Raja Isteri Pengiran Anak
Saleha Appendicitis (RIPASA) score. Histopathology was set as the
gold standard. We found that AIR and RIPASA scores had better diagnostic
accuracy as compared to MASS. |