| CTRI Number |
CTRI/2019/03/018036 [Registered on: 12/03/2019] Trial Registered Prospectively |
| Last Modified On: |
21/10/2022 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Role of preoperative nutrition in healing and recovery in children undergoing surgery |
|
Scientific Title of Study
|
Role of preoperative nutritional status over operative outcome in children undergoing surgery |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Gowri Shankar |
| Designation |
Associate Professor |
| Affiliation |
Indira Gandhi Institute of Child Health |
| Address |
South Hospital complex
Dharmaram college road
Dharmaram post
Bangalore 560029
Bangalore
KARNATAKA
560029
India |
| Phone |
|
| Fax |
|
| Email |
bcgshankar@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Gowri Shankar |
| Designation |
Associate Professor |
| Affiliation |
Indira Gandhi Institute of Child Health |
| Address |
South Hospital complex
Dharmaram college road
Dharmaram post
Bangalore 560029
KARNATAKA
560029
India |
| Phone |
|
| Fax |
|
| Email |
bcgshankar@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Gowri Shankar |
| Designation |
Associate Professor |
| Affiliation |
Indira Gandhi Institute of Child Health |
| Address |
South Hospital complex
Dharmaram college road
Dharmaram post
Bangalore 560029
KARNATAKA
560029
India |
| Phone |
|
| Fax |
|
| Email |
bcgshankar@gmail.com |
|
|
Source of Monetary or Material Support
|
| Rajiv Gandhi University of Health Sciences Karnataka |
|
|
Primary Sponsor
|
| Name |
Rajiv Gandhi University of Health Sciences Karnataka |
| Address |
Rajiv Gandhi University of Health Sciences Karnataka
4th T Block Jayanagar
Bangalore 560 041 |
| Type of Sponsor |
Government funding agency |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 2 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Gowri Shankar |
Indira Gandh iInstitute of Child health |
South hospital complex
Dharmaram college road
Dharmaram post
Bangalore 560029
Bangalore
KARNATAKA |
9845804491
bcgshankar@gmail.com |
| Dr Gowri Shankar |
Indira Gandhi Institute of Child Health |
Department of Pediatric Surgery
Surgery ward second floor
Outpatient no 6
South Hospital complex
Dharmaram college road
Dharmaram post
Bangalore
KARNATAKA |
9845804491
bcgshankar@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| Indira Gandhi Institute of Child Health |
Approved |
| Indira Gandhi Institute of Child Health |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K00-K95||Diseases of the digestive system, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
4.00 Month(s) |
| Age To |
16.00 Year(s) |
| Gender |
Both |
| Details |
All infants and children above the age of 3 months requiring major surgical procedures will be included into the study. |
|
| ExclusionCriteria |
| Details |
Children requiring emergency surgery
Children below 3 months of age
Children with documented nutritional deficiency
Children undergoing minor surgery
Children with confounding factors, where outcome is unlikely to be related to nutrition.
Children with severe malnutrition status as documented on anthropometry, SGNA (subjective global nutritional assessment) or standard biochemical analysis |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1 Estimate the prevalence of micronutrient deficiency in children undergoing major surgery.
2 Outline the relationship between micro nutrient deficiency and clinical outcomes in children undergoing non-emergent surgery |
The blood samples will be collected and stored as per lab requirements. they will be analysed for the values in batches of 50-100. This would approximately be once in 3 months based on our hospital statistics. final assessment will be at completion of study ( 300 now) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1 To correlate micronutrient deficiency, anthropometry and conventional nutritional parameters to identify and define pre-surgical nutritional indicators predictive of nutrition related complications so as to aid in development of uniform screening tools that suits Indian population
2 Evidence-based analysis of the impact of micro nutrient deficiency on patient outcomes
|
2 years |
|
|
Target Sample Size
|
Total Sample Size="300"
Sample Size from India="300"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="0" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
15/03/2019 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="2"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
not yet done
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
Brief Summary
Modification(s)
|
Malnutrition among hospitalized children is known to negatively influence their response to therapy and to prolong their admission especially in a surgical setting. It also has short and long term consequences for growth development and well being. There is no study describing the prevalence of malnutrition among hospital children undergoing surgery in an Indian setting. Problems exist in evaluating the effect of preoperative malnutrition on surgical outcomes due to a lack of unified definition of malnutrition assessment techniques and a paucity of randomized controlled trials correlating a statistically significant relationship between preoperative malnutrition and post operative outcomes. Our study proposes to study the prevalence of malnutrition in a hospital setting assess each variable ie anthropometric values biochemical markers and subjective assessment in diagnosing malnutrition and predicting adverse events in such children. This will help us develop a low cost reliable diagnostic scoring system able to predict nutritional associated complications ie NAC. This would also guide us to intervene in such children before surgical procedure so as to improve outcomes. This scoring system would become part of preoperative evaluations in all children being planned for surgery in future. |