| CTRI Number |
CTRI/2009/091/000070 [Registered on: 05/03/2009] |
| Last Modified On: |
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| Post Graduate Thesis |
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| Type of Trial |
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Type of Study
|
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| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A clinical trial to study the effect of oral carbohydrate drink on outcome after colorectal operations |
|
Scientific Title of Study
|
The effect of preoperative carbohydrate loading in major colorectal resections: a randomized controlled trial |
| Trial Acronym |
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Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
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Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
SUDIP BANDYOPADHYAY |
| Designation |
|
| Affiliation |
|
| Address |
Surgery Unit 5 CMC Hospital
Division of GI surgery, CMC Hospital
Vellore
TAMIL NADU
632004
India |
| Phone |
04162282085 |
| Fax |
04162232035 |
| Email |
sudeepcmcv@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
BENJAMIN PERAKATH |
| Designation |
|
| Affiliation |
MS FRCS |
| Address |
Surgery Unit 5 CMC Hospital
Division of GI surgery, CMC Hospital
Vellore
TAMIL NADU
632004
India |
| Phone |
04162282085 |
| Fax |
04162232035 |
| Email |
benjamin@cmcvellore.ac.in |
|
Details of Contact Person
Public Query
|
| Name |
BENJAMIN PERAKATH |
| Designation |
|
| Affiliation |
|
| Address |
Surgery Unit 5 CMC Hospital
Division of GI surgery, CMC Hospital
Vellore
TAMIL NADU
632004
India |
| Phone |
04162282085 |
| Fax |
04162232035 |
| Email |
benjamin@cmcvellore.ac.in |
|
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Source of Monetary or Material Support
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Primary Sponsor
|
| Name |
CMC VELLORE |
| Address |
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| Type of Sponsor |
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Details of Secondary Sponsor
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Countries of Recruitment
|
India |
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Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| BENJAMIN PERAKATH |
SURGERY UNIT 5 |
CMC HOSPITAL,DIVISION OF GI SURGERY-632004
Vellore
TAMIL NADU |
04162282085
04162232035
benjamin@cmcvellore.ac.in |
|
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Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL REVIEW BOARD CMC VELLORE |
Approved |
|
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Regulatory Clearance Status from DCGI
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
colorectal disease, |
|
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Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
ORAL CARBOHYDRATE LOADING |
PRE OPERATIVE TWO DOSES |
| Comparator Agent |
ORAL WATER LOADING |
PREOPERATIVE TWO DOSES |
|
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Inclusion Criteria
|
| Age From |
|
| Age To |
|
| Gender |
|
| Details |
ADULT
COLORECTAL MAJOR RESECTIONS |
|
| ExclusionCriteria |
| Details |
DM
LIVER DISEASE
RENAL DISEASE
MULTIVISCREAL RESECTION
COMPLEX RECONSTRUCTION
GERD
OBESITY |
|
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Method of Generating Random Sequence
|
Computer generated randomization |
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Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
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Blinding/Masking
|
Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded |
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Primary Outcome
|
| Outcome |
TimePoints |
| DURATION OF HOSPITAL STAY
|
UPTO DISCHARGE |
|
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Secondary Outcome
|
| Outcome |
TimePoints |
| MUSCLE POWER
BOWEL FUNCTION
COMPLICATION |
UPTO DISCHARGE |
|
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Target Sample Size
|
Total Sample Size="32"
Sample Size from India=""
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
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Phase of Trial
|
Phase 2/ Phase 3 |
|
Date of First Enrollment (India)
|
Date Missing |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
01/05/2007 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="2"
Months="0"
Days="0" |
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Recruitment Status of Trial (Global)
|
Open to Recruitment |
| Recruitment Status of Trial (India) |
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Publication Details
|
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Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
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Brief Summary
|
This study is a randomized double blinded trial to identify the clinical benefit of preoperative oral carbohydrate loading before major colorectal resection. The primary endpoint is duration of post operative hospital stay. The secondary end pionts are assessment of muscle power, return of bowel function and complications |