| CTRI Number |
CTRI/2021/09/036665 [Registered on: 20/09/2021] Trial Registered Prospectively |
| Last Modified On: |
16/09/2021 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Other |
|
Public Title of Study
|
Evaluation of telephonic interview versus in person follow up after surgical procedures |
|
Scientific Title of Study
|
Evaluation of telephonic interview versus in person follow up after surgical procedures |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Hariharasaran K I |
| Designation |
PG student |
| Affiliation |
SAGAR HOSPITALS |
| Address |
General surgery department Sagar Hospitals, Jayanagar 44/54, 30th Cross Road,Tilak Nagar, Jayanagar, Bengaluru - 560 041 Karnataka, India
19/470, 3rd main 4th cross
dollars colony btm second stage Bengaluru - 560 076 Karnataka India
Bangalore
KARNATAKA
560041
India |
| Phone |
9597663505 |
| Fax |
|
| Email |
drharisaran94@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Lakshman K |
| Designation |
Consultant General Surgeon |
| Affiliation |
Sagar Hospital |
| Address |
General surgery department Sagar Hospitals, Jayanagar 44/54, 30th Cross Road,Tilak Nagar, Jayanagar, Bengaluru - 560 041 Karnataka, India
58/4 2nd main thyagarajanagar Bangalore 560028 karnataka
Bangalore
KARNATAKA
560041
India |
| Phone |
9597663505 |
| Fax |
|
| Email |
klakshman58@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Hariharasaran K I |
| Designation |
PG student |
| Affiliation |
Sagar Hospital |
| Address |
General Surgery department, Sagar Hospitals, Jayanagar 44/54, 30th Cross Road,Tilak Nagar, Jayanagar, Bengaluru - 560 041 Karnataka, India
19/470 3rd main 4th cross dollors colony btm 2nd stage Bengaluru 560076 Karnataka
Bangalore
KARNATAKA
560041
India |
| Phone |
9597663505 |
| Fax |
|
| Email |
drharisaran94@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sagar hospitals, Jayanagar, Bengaluru |
|
|
Primary Sponsor
|
| Name |
SAGAR HOSPITALS |
| Address |
Sagar Hospitals, Jayanagar 44/54, 30th Cross Road,Tilak Nagar, Jayanagar, Bengaluru - 560 041 Karnataka, India. |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Hariharasaran K I |
Sagar Hospital |
General Surgery Department, Sagar Hospitals, Jayanagar 44/54, 30th Cross Road,Tilak Nagar, Jayanagar, Bengaluru - 560 041 Karnataka, India.
Bangalore
KARNATAKA |
9597663505
drharisaran94@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
, (1) ICD-10 Condition: R50-R69||General symptoms and signs, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Both |
| Details |
All patients undergoing surgery in the Department of General surgery, Surgical oncology and Thoracic surgery |
|
| ExclusionCriteria |
| Details |
Surgery on patients less than 18 years of age
Surgery on patients who are hard of hearing
Surgery on patients who are mentally challenged
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| TO EVALUATE WHETHER THE TELEPHONIC FOLLOW UP IS ACCURATE AND GIVE INFORMATION AS IN PERSON FOLLOW UP |
FOURTH DAY TELEPHONIC FOLLOW UP AND SEVENTH DAY IN PERSON FOLLOW UP |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| TO EVALUATE WHETHER THE TELEPHONIC FOLLOW UP IS ACCURATE AND GIVE INFORMATION AS IN PERSON FOLLOW UP BY ASSESSING EXTRA FINDINGS IN TELEPHONIC FOLLOW UP |
FOURTH DAY TELEPHONIC FOLLOW UP AND SEVENTH DAY IN PERSON FOLLOW UP |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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)
|
30/09/2021 |
| 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
|
NONE YET |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - YES
- What data in particular will be shared?
Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
- What additional supporting information will be shared?
Response - Clinical Study Report
- Who will be able to view these files?
Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.
- For what types of analyses will this data be available?
Response - For individual participant data meta-analysis.
- By what mechanism will data be made available?
Response - Proposals should be directed to [drharisaran94@gmail.com].
- For how long will this data be available start date provided 10-09-2022 and end date provided 10-09-2026?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
Traditionally patients are expected to report back to the hospital after surgery for a follow up with their respective surgeons. Although this offers psychological support to the patients this involves logistical issues such as travelling and the need to take a day off in order to visit the doctor and the associated costs. Particularly in recent times because of Covid infection and people wanting to avoid another hospital visit, the option of telephonic follow up have to be analyzed. In this study we aim to assess the effectiveness of a telephonic interview with the traditional in person follow up after surgery. Patients enrolled in the study will receive a call from a healthcare professional one or two days prior to their scheduled visit to the hospital for their first postoperative follow up. The questionnaire will then be asked in the form of a telephonic interview by the healthcare professional and data entered on to the google forms. The primary surgeon will then carry out their routine postoperative in-person follow up and enter their findings in a separate google form. At this interview, the surgeon will look for complaints not reported during telephonic interviews and surprise clinical findings that were not expected from the details derived from the telephonic interview and finally the google forms will be compared and analyzed by an independent observer |