| CTRI Number |
CTRI/2023/08/056790 [Registered on: 23/08/2023] Trial Registered Prospectively |
| Last Modified On: |
22/08/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
feeding practices after non abdominal surgery |
|
Scientific Title of Study
|
Post-operative feeding practices after elective non-abdominal surgery in a tertiary care centre: An observational study |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| nil |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Nireeksha |
| Designation |
MSc Student |
| Affiliation |
Manipal college of health professions |
| Address |
Anaesthesia and Operation Theatre Technology program, MCHP, MAHE
Udupi
KARNATAKA
576104
India |
| Phone |
7483351731 |
| Fax |
|
| Email |
nireekshaarun79@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Nisha Sara Mundappallil Jacob |
| Designation |
Assistant professor |
| Affiliation |
Kasturba medical college and hospital |
| Address |
Department of Anaesthesia, KMC, MAHE
Udupi
KARNATAKA
576104
India |
| Phone |
9500574751 |
| Fax |
|
| Email |
nishasara@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Ms Anju |
| Designation |
Assistant Lecturer and Program Coordinator |
| Affiliation |
Manipal college of health professions |
| Address |
Anaesthesia and Operation Theatre Technology program, MCHP, MAHE
Udupi
KARNATAKA
576104
India |
| Phone |
7899963044 |
| Fax |
|
| Email |
anjuuday17@gmail.com |
|
|
Source of Monetary or Material Support
|
| Kasturba medical college and Hospital, Manipal Udupi karnataka 576104 |
| Manipal college of Health Professions, Manipal, Udupi Karnataka 576104 |
|
|
Primary Sponsor
|
| Name |
Ms Nireeksha |
| Address |
Anaesthesia and Operation Theatre Technology
program, MCHP, MAHE, Manipal |
| Type of Sponsor |
Other [Self] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 3 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Ms Nireeksha |
Kasturba medical collage and hospital |
Preoperative ward, Department of Anaesthesiology
Udupi
KARNATAKA |
7483351731
nireekshaarun79@gmail.com |
| Ms Nireeksha |
Kasturba medical collage and hospital |
Post Anaesthesia Care unit, department of Anaesthesiology
Udupi
KARNATAKA |
7483351731
nireekshaarun79@gmail.com |
| Ms Nireeksha |
Kasturba medical collage and hospital |
Post operative ward Department of Anaesthesiology
Udupi
KARNATAKA |
7483351731
nireekshaarun79@gmail.com |
|
|
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: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
Patients above 18 years of age undergoing elective non-abdominal surgery. ASA I, II, III, IV Paitients |
|
| ExclusionCriteria |
| Details |
Patients undergoing
o Gastrointestinal surgery
o Transplantation
o Pregnant women
o Neurosurgery
o Cardiothoracic surgery
o Intraoral-maxillofacial surgery
o Patients with impaired speech and hearing
|
|
|
Method of Generating Random Sequence
|
|
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
| To estimate the average post-operative feeding time in patients undergoing elective nonabdominal surgery. |
every 1 hour after surgery till 6 hours post surgery |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To estimate the difference between the instructed post-operative feeding time versus the
actual feeding time.
|
every 1 hour after surgery till 6 hours post surgery |
|
|
Target Sample Size
|
Total Sample Size="258"
Sample Size from India="258"
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)
|
01/09/2023 |
| 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="0"
Months="8"
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 is the cross-sectional
observation study titled "Post-operative feeding practices after elective
non-abdominal surgery in a tertiary care centre: An observational study".
Patients above 18 years old with ASA class below V undergoing elective non-abdominal
surgery will be recruited. The primary objective of the study is to estimate
the average post-operative feeding time in patients undergoing elective
non-abdominal surgery and secondary objective is to estimate the difference
between the instructed post-operative feeding time versus the actual feeding
time. |