| CTRI Number |
CTRI/2024/01/061718 [Registered on: 22/01/2024] Trial Registered Prospectively |
| Last Modified On: |
21/01/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [feeding in ERAS protocol] |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Pre-operative carbohydrate loading-Glucose vs Maltodextrin |
|
Scientific Title of Study
|
Effect of glucose water as an alternative to maltodextrin solution for preoperative oral carbohydrate loading as a part of ERAS protocol in patients undergoing curative elective laparotomy for abdominal malignancies - A randomised controlled trial |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DILLIP KUMAR MUDULY |
| Designation |
Additional professor |
| Affiliation |
All India Institute of Medical Science |
| Address |
5th Floor,Department of surgical oncology,AIIMS Bhubaneswar,Patrapada Sijua Bhubaneswar
Patrapada Sijua Bhubaneswar
Khordha
ORISSA
751019
India |
| Phone |
06742476067 |
| Fax |
|
| Email |
surgonco_dillip@aiimsbhubaneswar.edu.in |
|
Details of Contact Person
Scientific Query
|
| Name |
DILLIP KUMAR MUDULY |
| Designation |
Additional professor |
| Affiliation |
All India Institute of Medical Science |
| Address |
5th Floor,Department of surgical oncology,AIIMS Bhubaneswar,Patrapada Sijua Bhubaneswar
Patrapada Sijua Bhubaneswar
Khordha
ORISSA
751019
India |
| Phone |
06742476067 |
| Fax |
|
| Email |
surgonco_dillip@aiimsbhubaneswar.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
SATYAPRAKASH KUILA |
| Designation |
Senior resident |
| Affiliation |
All India Institute of Medical Science |
| Address |
5th Floor,Department of surgical oncology,AIIMS Bhubaneswar,Patrapada Sijua Bhubaneswar
Patrapada Sijua Bhubaneswar
Khordha
ORISSA
751019
India |
| Phone |
9038873822 |
| Fax |
|
| Email |
satya.kuila81@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
AIIMS, Bhubaneswar |
| Address |
Sijua, Patrapada, Bhubaneswar Odisha 751019 |
| 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 |
| Dillip Kumar Muduly |
All India Institute of medical sciences Bhubaneswar |
I+3 ward,3rd floor,Department of surgical oncology,Patrapada Sijua Bhubaneswar
Khordha
ORISSA |
9013072969
surgonco_dillip@aiimsbhubaneswar.edu.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC AIIMS Bhubaneswar |
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 |
Glucose water |
Preopeartive carbohydrate loading in ERAS protocol(to be taken 2 hours before anesthesia induction 250ml to drink over 20 mins) |
| Comparator Agent |
Maltodextrin solutions |
Preoperative carbohydrate loading in ERAS protocol(to be taken 2 hours before anesthesia induction,250ml to drink over 20 mins) |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Adult patients (age >18,<70 yrs) undergoing curative elective laparotomy for abdominal malignancies in the department of surgical oncology, AIIMS BBSR |
|
| ExclusionCriteria |
| Details |
1. Patients with uncontrolled Diabetes mellitus.
2. Patients with gastric outlet obstruction
3.Patients on preoperative steroid therapy
4.Patients with renal failure
5.Patients with hepatic failure
6.Patients with gastroesophageal reflux disease
7.History of previous stomach surgery
8.Patients with poor Performance status.(ECOG≥2)
9.Patients not willing to participate.
|
|
|
Method of Generating Random Sequence
|
Stratified block randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| postoperative glycemic control |
December 2023 to May 2025 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To assess and compare the effect of both on
1.patient perception of subjective well being
2.inflammatory response and postoperative clinical outcomes.
3.Requirement of interventions/2nd surgery/readmissions
4.insulin resistance
|
December 2023 to May 2025 |
|
|
Target Sample Size
|
Total Sample Size="48"
Sample Size from India="48"
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
|
Phase 2/ Phase 3 |
|
Date of First Enrollment (India)
|
10/02/2024 |
| 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="6"
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
|
Preoperative carbohydrate loading has been established as the standard ERAS protocol.Maltodextrin are used for this practice.Simple carbohydrates can be used for this purpose as maltodextrinx are relatively expensive.Our study aims to use simple carbohydrates for preoperative carbohydarte loading and evaluate the effects on glycemic control and compare its effect with maltodextrins. |