| CTRI Number |
CTRI/2026/03/106539 [Registered on: 19/03/2026] Trial Registered Prospectively |
| Last Modified On: |
19/03/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Nutraceutical |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Effect of drinking a carbohydrate drink before surgery on blood sugar control and recovery after gastrointestinal cancer surgery |
|
Scientific Title of Study
|
Effect of pre-operative Carbohydrate loading on post-operative Insulin Resistance in
patients undergoing surgery for Gastrointestinal malignancy:
A Randomized 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 |
Kunal Kalani |
| Designation |
Junior Resident |
| Affiliation |
All India Institute of Medical Sciences (AIIMS), Patna |
| Address |
Department of Surgical Gastroenterology, AIIMS Patna, Phulwarisharif, Patna, Bihar-801507, India
Patna
BIHAR
801507
India |
| Phone |
9996633602 |
| Fax |
|
| Email |
kalanikunal4@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Kislay Kant |
| Designation |
Assistant Professor |
| Affiliation |
All India Institute of Medical Sciences (AIIMS), Patna |
| Address |
Department of Surgical Gastroenterology, AIIMS Patna, Phulwarisharif, Patna, Bihar-801507, India
Patna
BIHAR
801507
India |
| Phone |
9958615755 |
| Fax |
|
| Email |
kislay.kant@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Kunal Kalani |
| Designation |
Junior Resident |
| Affiliation |
All India Institute of Medical Sciences (AIIMS), Patna |
| Address |
Department of Surgical Gastroenterology, AIIMS Patna, Phulwarisharif, Patna, Bihar-801507, India
Patna
BIHAR
801507
India |
| Phone |
9996633602 |
| Fax |
|
| Email |
kalanikunal4@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Surgical Gastroenterology, AIIMS Patna, Phulwarisharif, Patna, Bihar-801507, India |
|
|
Primary Sponsor
|
| Name |
Department of Surgical Gastroenterology |
| Address |
4th Floor, OPD Block, AIIMS Patna, Phulwarisharif, Patna, Bihar-801507, India |
| 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 |
| Dr Kunal Kalani |
All India Institute of Medical Sciences Patna |
Room No 420, 4th Floor, OPD Block, Phulwarisharif, Patna, Bihar-801507, India
Patna
BIHAR |
9996633602
kalanikunal4@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee,AIIMS Patna |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K35-K38||Diseases of appendix, (2) ICD-10 Condition: K20-K31||Diseases of esophagus, stomach and duodenum, (3) ICD-10 Condition: K70-K77||Diseases of liver, (4) ICD-10 Condition: K80-K87||Disorders of gallbladder, biliary tract and pancreas, (5) ICD-10 Condition: K55-K64||Other diseases of intestines, (6) ICD-10 Condition: K90-K95||Other diseases of the digestive system, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Conventional Pre operative Fasting Group |
patient will be kept conventional preoperative fasting starting at midnight before surgery. |
| Intervention |
Oral Carbohydrate Drink |
OCL group (oral carbohydrate loading) will receive 400 ml of clear carbohydrate drink (maltose dextrin,12.5g of carbohydrate per 100ml) at 10pm the day before surgery and another 200 ml of carbohydrate drink 2 hours before surgery. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Both |
| Details |
Patients admitted for elective surgery for GI malignancy in Surgical Gastroenterology department in AIIMS Patna
Age more than 18 years
If the disease turns out to be metastatic at some later point in the study
|
|
| ExclusionCriteria |
| Details |
Emergency surgeries
Metastatic disease
Patients presenting with Gastric outlet obstruction, Dysphagia, Intestinal Obstruction
Known cases of chronic diseases such as uncontrolled Diabetes Mellitus(HbA1c more than or equal to 6.5%), Chronic Liver Disease, Chronic Kidney Disease
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare the effect of oral carbohydrate loading and preoperative prolonged fasting over the Insulin resistance seen post operatively in patients undergoing surgery for Gastrointestinal malignancies using the HOMA-IR calculator |
Pre-operatively, Post operative day 1, Post operative Day 3 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| The post operative complications on the basis of Clavein-Dindo classification |
Pre-operatively, Post operative day 1, Post operative Day 3 |
The post operative time to discharge based on fulfillment of the following criteria:
A. Passage of stools/ Functional moving stoma
B. Tolerating soft diet
C. No or minimal tolerable abdominal pain
D. Drain removed/ Drain output less than 50ml
|
Pre-operatively, Post operative day 1, Post operative Day 3 |
| The post operative CRP in patients undergoing surgery for Gastrointestinal malignancies |
Pre-operatively, Post operative day 1, Post operative Day 3 |
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
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)
|
01/04/2026 |
| 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 Yet Recruiting |
| 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
|
This single-centre randomized controlled trial will evaluate the effect of preoperative carbohydrate loading on postoperative insulin resistance in patients undergoing elective surgery for gastrointestinal malignancies at AIIMS Patna. A total of 80 adult patients (>18 years) will be enrolled and randomized into two groups: conventional overnight fasting (n=40) and oral carbohydrate loading (n=40) using maltodextrin solution administered the night before and 2 hours before surgery. The primary outcome will be postoperative insulin resistance measured using the HOMA-IR index on postoperative days 1 and 3. Secondary outcomes include postoperative complications (Clavien–Dindo classification), postoperative CRP levels, and time to hospital discharge. |