| CTRI Number |
CTRI/2020/04/024733 [Registered on: 20/04/2020] Trial Registered Prospectively |
| Last Modified On: |
19/05/2022 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Preoperative evaluation of malnutrition using malnutrition universal screening tool(MUST),Malnutrition assessment short form(MNA-SF) and Calf Circumference(CC) in predicting postoperative problems in head and neck and gastrointestinal cancer patients |
|
Scientific Title of Study
|
Preoperative evaluation of malnutrition using Malnutrition universal screening tool(MUST),malnutrition assessment short form(MNA-SF),and Calf Circumference(CC) in predicting postoperative morbidity in head and neck and gastrointestinal cancer patients. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
NIVEDHYAA |
| Designation |
ASSISTANT PROFESOR |
| Affiliation |
Cancer Institute (WIA) |
| Address |
B-1,SDS PEARL,AJANTHA AVENUE,VENKATESAPURAM,
KOTTIVAKKAM
SARDAR PATEL ROAD
Chennai
TAMIL NADU
600041
India |
| Phone |
9597423654 |
| Fax |
|
| Email |
nivedhyaa@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
NIVEDHYAA |
| Designation |
Assistant Professor |
| Affiliation |
Cancer Institute (WIA) |
| Address |
B-1,SDS PEARL,AJANTHA AVENUE,VENKATESAPURAM,
KOTTIVAKKAM
SARDAR PATEL ROAD
Chennai
TAMIL NADU
600041
India |
| Phone |
9597423654 |
| Fax |
|
| Email |
nivedhyaa@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
nivedhyaa |
| Designation |
Assistant Professor |
| Affiliation |
Cancer Institute (WIA) |
| Address |
B-1,SDS Pearl,Ajantha Avenue,Venkatesapuram
sardar patel road,Adayar
TAMIL NADU
600041
India |
| Phone |
9597423654 |
| Fax |
|
| Email |
nivedhyaa@gmail.com |
|
|
Source of Monetary or Material Support
|
| CANCER INSTITUTE,SARDAR PATEL ROAD, NEXT TO IIT CHENNAI,ADYAR.600020 |
|
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Primary Sponsor
|
| Name |
Nivedhyaa |
| Address |
B-1,SDS Pearl,Ajantha Avenue,Kottivakkam |
| Type of Sponsor |
Research institution and hospital |
|
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Details of Secondary Sponsor
|
|
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Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Nivedhyaa S |
Cancer institute(WIA) |
ROOM NO 10,PREANESTHETIC CLINIC,DEPARTMENT OF ANESTHESIA,SARDAR PATEL ROAD
ADYAR-600020
Chennai
TAMIL NADU |
9597423654
nivedhyaa@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTE ETHICS COMMITTEE |
Approved |
|
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Regulatory Clearance Status from DCGI
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E43||Unspecified severe protein-caloriemalnutrition, |
|
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Intervention / Comparator Agent
|
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Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
All head and Neck
Gastrointestinal Cancer patients |
|
| ExclusionCriteria |
| Details |
Patients below 18 years
Patients undergoing Emergency surgeries |
|
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Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare MUST,MNA-SF and Calf Circumference and to identify which amongst the three is better preoperative screening tool for assessment of malnutrition in our cohort of patients against the gold standard European Society for Clinical Nutrition and Metabolism (ESPEN) guidelines for malnutrition |
Until day of surgery |
|
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Secondary Outcome
|
| Outcome |
TimePoints |
Secondary outcome:Which of the nutritional screening tools reflected on the postoperative morbidity |
To be followed until discharge to identify the length of stay and thirty day readmission |
|
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Target Sample Size
|
Total Sample Size="300"
Sample Size from India="300"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="0" |
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Phase of Trial
|
Phase 2/ Phase 3 |
|
Date of First Enrollment (India)
|
21/04/2020 |
| 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="0"
Months="6"
Days="20" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
Published the results in Journal of supportive care in cancer
|
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Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
Preoperative poor nutritional state and weight loss are a major cause of postoperative morbidity.Reduced food intake,pain,decreased mouth opening,age ,vomiting,dysphagia,gastrointestinal obstruction,radiation are factors that influence perioperative nutrition in these patients
Definition of the Problem: There is a need for detailed assessement of nutrition in the pre anesthetic clinic and to identify undernourished patients.We retrospectively analysed 37 patients who underwent major GI and head and neck cancer surgeries in the month of january 2020 .The prevelance of malnutrition was 13% amongst 37 patients.50% of the malnourished patients had surgical site infection.The main objective of the study is to identify which amongst the three tools are effective in predicting malnutrition and the secondary objective if malnutrition is a major cause of postoperative infectionMaterials and Methods:This will be a prospective observational study in which all patients will undergo the three screening tests at the pre anesthetic check up after obtaining consent from them.They will be followed up until discharge to know the length of hospital stay ,infection any type,antibiotic escalation,30 day mortality and readmission |