| CTRI Number |
CTRI/2017/08/009222 [Registered on: 02/08/2017] Trial Registered Prospectively |
| Last Modified On: |
01/08/2017 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Follow Up Study |
| Study Design |
Other |
|
Public Title of Study
|
Impacts of Nutritional Status before surgery on recovery after surgery. |
|
Scientific Title of Study
|
Impacts of pre-nutritional status on post-surgical convalescence. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Suhana S Shriyan |
| Designation |
MSc DAN Second year Semester |
| Affiliation |
Manipal University |
| Address |
Dept of Allied Hospitality Studies, WGSHA, Manipal Dakshina kannada
Udupi
KARNATAKA
576104
India |
| Phone |
9844629563 |
| Fax |
|
| Email |
suhanashriyan9@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Meenakshi Garg |
| Designation |
Asst. Prof._Selection Grade and HOD MSc Dietetics and Applied Nutrition |
| Affiliation |
Manipal University |
| Address |
Dept of Allied Hospitality Studies, WGSHA, Manipal Dakshina kannada
Udupi
KARNATAKA
576104
India |
| Phone |
934316327 |
| Fax |
|
| Email |
meenakshi.garg@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Pooja Bojamma |
| Designation |
MSc DAN Second year Semester |
| Affiliation |
Manipal University |
| Address |
Dept of Allied Hospitality Studies, WGSHA, Manipal Dakshina kannada
Udupi
KARNATAKA
576104
India |
| Phone |
9742480611 |
| Fax |
|
| Email |
poojabojamma@gmail.com |
|
|
Source of Monetary or Material Support
|
| Kasturba Medical College and Hospital, Manipal university, Manipal-576104 |
|
|
Primary Sponsor
|
| Name |
Meenakshi Garg |
| Address |
Asst. Prof._Selection Grade and HOD MSc Dietetics and Applied Nutrition, Department of Allied Hospitality Studies, WGSHA, Manipal-576104 |
| Type of Sponsor |
Other [HOD of MSc DAN] |
|
|
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 |
| Suhana S Shriyan |
Kasturba Hospital |
Kasturba Medical College and Hospital, Manipal University, Manipal-576104
Udupi
KARNATAKA |
9844629563
suhanashriyan9@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 |
General Surgery, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
Patients undergoing elective surgery from KH/ KMC. |
|
| ExclusionCriteria |
| Details |
1) Patients who are unable to give information due to the severity of the condition.
2) Age group below 18 years.
3) Patients who immuno-compromised.
4) Trauma, accident and minor surgeries.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To assess impact of the pre-surgical nutritional status on post-surgical convalescence. |
General surgery patients- first visit for initial data collection before surgery(pre-nutritional status),second visit after surgery (post surgery outcome) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Nil |
Nil |
|
|
Target Sample Size
|
Total Sample Size="300"
Sample Size from India="300"
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)
|
05/08/2017 |
| 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="5"
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)?
|
|
Brief Summary
|
In most hospitals, its is observed that if pre-nutritional status is not maintained due to various factors like socio-economic status ,deficiencies ,like anemia,low protein intake, malnutrition (PEM or obesity ),co -morbid conditions ,already existing immuno-compromised condition which decreases food intake etc,then it will affect the post -surgical outcome and the length of stay.
The Objectives of this study are- To assess the complete Pre-surgical nutritional status .To check the progress or recovery of the Post-surgical patient i.e., the impact of malnutrition, infection and morbidity on the length of the stay.To give the education material at the end of the study. |