| CTRI Number |
CTRI/2025/02/081310 [Registered on: 25/02/2025] Trial Registered Prospectively |
| Last Modified On: |
23/02/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Prospective observational study |
| Study Design |
Other |
|
Public Title of Study
|
A mobile app to predict the treatment plan for intestinal obstruction. |
|
Scientific Title of Study
|
Treatment plan predicting mobile application program for acute intestinal obstruction. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Pakalapati Chandralekha |
| Designation |
Post Graduate,General Surgery |
| Affiliation |
Saveetha Medical College and Hospital |
| Address |
Second Floor,Department of General Surgery,Saveetha medical College and hospital,Saveetha nagar, Thandalam,Chennai.
Chennai
TAMIL NADU
602105
India |
| Phone |
7702117534 |
| Fax |
|
| Email |
lekhacp1995@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
P.B.Sudarshan |
| Designation |
Professor ,General Surgery |
| Affiliation |
Saveetha Medical College and Hospital |
| Address |
Second Floor,Department of General Surgery, Saveetha Medical College and Hospital,Saveetha Nagar, Thandalam,Chennai.
Chennai
TAMIL NADU
602105
India |
| Phone |
9789859925 |
| Fax |
|
| Email |
pbsudarshan@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Pakalapati Chandralekha |
| Designation |
Post Graduate,General Surgery |
| Affiliation |
Saveetha Medical College and Hospital |
| Address |
Second Floor, Department of General Surgery,Saveetha medical College and Hospital,Saveetha Nagar, Thandalam,Chennai.
Chennai
TAMIL NADU
602105
India |
| Phone |
7702117534 |
| Fax |
|
| Email |
lekhacp1995@gmail.com |
|
|
Source of Monetary or Material Support
|
| Saveetha Medical College and Hospital, Saveetha Nagar, Thandalam,Chennai,602105.Thandalam,Chennai,India.602105. |
|
|
Primary Sponsor
|
| Name |
DrChandralekha Pakalapati |
| 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 |
| Dr Pakalapati Chandralekha |
Saveetha Medical college |
Department of General Surgery, Saveetha Medical College and Hospital, Thandalam, Chennai - 602105
Chennai
TAMIL NADU |
7702117534
lekhacp1995@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: K55-K64||Other diseases of intestines, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
All patients who are willing to undergo the study and patients with Acute intestinal obstruction coming to ER.
|
|
| ExclusionCriteria |
| Details |
All patients who are not willing to undergo the study |
|
|
Method of Generating Random Sequence
|
|
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
| To find out efficiency of new app in predicting efficient treatment plan for acute intestinal obstruction cases. |
1 month |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Clinical improvement of the patient |
1 month |
|
|
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)
|
07/03/2025 |
| 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="11"
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
|
Management of acute intestinal obstruction has consequently been challenging as whether to operate or to treat conservatively, hence my study aims to develop a new app for a surgeon to predict the treatment plan in cases of acute intestinal obstruction.It is a prospective observational study, done for a period of 13months which includes patients with acute intestinal obstruction admitted in emergency department of saveetha medical college. Different clinical parameters are assessed and scored using the the mobile app through which the treatment plan was predicted ,and the results were assessed. |