| CTRI Number |
CTRI/2025/04/083793 [Registered on: 01/04/2025] Trial Registered Prospectively |
| Last Modified On: |
30/03/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
to compare the improvement in post operative complications and outcomes and the neutrophil/lymphocyte markers between preoperative carbohydrate loading and conventional fasting groups in elective colorectal cancer surgeries |
|
Scientific Title of Study
|
Effects of preoperative oral carbohydrate loading on postoperative outcomes and change in neutrophil/lymphocyte ratio and following elective colorectal cancer surgery : A randomized controlled study |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Jinendra Jain |
| Designation |
Junior Resident |
| Affiliation |
Jawaharlal Institute of Postgraduate Medical Education and Research |
| Address |
Department of Surgery, 2nd floor, Old Block, Jipmer Campus Rd, Jipmer Campus, Puducherry,
Department of Surgery, 2nd floor, Old Block, Jipmer Campus Rd, Jipmer Campus, Puducherry,
Pondicherry
PONDICHERRY
605006
India |
| Phone |
9910637328 |
| Fax |
|
| Email |
jinendra786@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Sreenath G S |
| Designation |
Additional Professor |
| Affiliation |
Jawaharlal Institute of Postgraduate Medical Education and Research |
| Address |
Department of Surgery, 2nd floor, Old Block, Jipmer Campus Rd, Jipmer Campus, Puducherry,
Department of Surgery, 2nd floor, Old Block, Jipmer Campus Rd, Jipmer Campus, Puducherry,
Pondicherry
PONDICHERRY
605006
India |
| Phone |
9486690883 |
| Fax |
|
| Email |
dr.sreenathgs@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Sreenath G S |
| Designation |
Additional Professor |
| Affiliation |
Jawaharlal Institute of Postgraduate Medical Education and Research |
| Address |
Department of Surgery, 2nd floor, Old Block, Jipmer Campus Rd, Jipmer Campus, Puducherry,
Department of Surgery, 2nd floor, Old Block, Jipmer Campus Rd, Jipmer Campus, Puducherry,
Pondicherry
PONDICHERRY
605006
India |
| Phone |
9486690883 |
| Fax |
|
| Email |
dr.sreenathgs@gmail.com |
|
|
Source of Monetary or Material Support
|
| Jawaharlal Institute of Postgraduate Medical Education and Research, Jipmer Campus Rd, Jipmer Campus, Puducherry, 605006, India |
|
|
Primary Sponsor
|
| Name |
Jinendra Jain |
| Address |
Jipmer Campus Rd, Jipmer Campus, Puducherry, 605006 |
| Type of Sponsor |
Other [Self] |
|
|
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 Sreenath G S |
Jawaharlal Institute of Postgraduate Medical Education and Research |
DEPARTMENT OF SURGERY, Old Block, JIPMER, Jipmer Campus Rd, Jipmer Campus, Puducherry, 605006, India
Pondicherry
PONDICHERRY |
9486690883
drsreenathgs@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Interventional Studies |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C18||Malignant neoplasm of colon, (2) ICD-10 Condition: C19||Malignant neoplasm of rectosigmoidjunction, (3) ICD-10 Condition: C20||Malignant neoplasm of rectum, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
maltodextrin solution 12.5g/100ml |
The patient in 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.
Peglec (Polyethylene glycol and electrolytes mix) used for bowel preparation as half a sachet (137.15gm per sachet) in 1L water mixed until homogenous and drank over 2 hours from 6PM to 8PM once on preoperative day.
Tablet Ciprofloxacin 500mg thrice a day and Tablet metronidazole 400mg thrice a day given 1 day before surgery for oral bowel preparation.
3rd Generation Cephalosporin (1g Ceftriaxone) given 1hour before the beginning of surgery.
|
| Comparator Agent |
No active intervention |
The patient in controlgroup will only recieve Peglec (Polyethylene glycol and electrolytes mix) used for bowel preparation as half a sachet (137.15gm per sachet) in 1L water mixed until homogenous and drank over 2 hours from 6PM to 8PM once on preoperative day and 1L over 2 hours in the morning of the surgery. Tablet Ciprofloxacin 500mg thrice a day and Tablet metronidazole 400mg thrice a day given 1 day before surgery for oral bowel preparation. 3rd Generation Cephalosporin (1g Ceftriaxone) given 1hour before the beginning of surgery. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
All patients admitted for elective colorectal surgery in JIPMER more than 18 years of age |
|
| ExclusionCriteria |
| Details |
1. Recurrent CRC
2. Emergency surgeries
3. Metastatic disease
4. Known cases of chronic diseases such as uncontrolled diabetes mellitus, uncontrolled hypertension, hematological illnesses.
5. Cases of psychiatric illnesses, in which cases consent will not be there.
|
|
|
Method of Generating Random Sequence
|
Permuted block randomization, fixed |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
To compare the effect of oral carbohydrate loading and preoperative prolonged fasting on
The post operative complications on the basis of Clavein-Dindo classification, and
GRADE 1 Elevated serum creatine
Confusion
GRADE 2 Pneumonia
Delirium
Uro-infection
Wound infection
GRADE 3 Anastomotic leakage
Ileus
Abdominal wall dehiscence
Reoperation
GRADE 4 Respiratory failure
Renal failure
Septic Shock
MODS
GRADE 5 Death of patient
|
upto 30 days post operatively |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
2. 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 30ml
E. No SSI requiring in hospital dressing and IV antibiotics
|
upto point of discharge |
| to compare the effect of oral carbohydrate loading group and prolonged fasting group over post operative neutrophil to lymphocyte ratio and the significance of change |
preoperative day before surgery
post operative day 1,3 and 5 |
|
|
Target Sample Size
|
Total Sample Size="68"
Sample Size from India="68"
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)
|
15/04/2025 |
| 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="0"
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
|
Title:
Effects of Preoperative Oral Carbohydrate Loading on Postoperative Outcomes and Change in Neutrophil/Lymphocyte Ratio Following Elective Colorectal Cancer Surgery: A Randomized Controlled Study.
Study Overview:
This randomized controlled trial (RCT) investigates the effects of preoperative oral carbohydrate loading (CHO) on postoperative outcomes and changes in the neutrophil/lymphocyte ratio (NLR) in colorectal cancer (CRC) patients undergoing elective surgery.
Background & Rationale: CRC is a leading cause of cancer-related deaths. Prolonged fasting before surgery triggers inflammatory responses, affecting patient recovery. CHO loading, part of Enhanced Recovery After Surgery (ERAS) protocol, may reduce post-surgical complications and improve immune response. • Change in NLR can serve as an inexpensive hematological marker to predict postoperative recovery and complications.
Objectives: 1. Primary: Compare postoperative complications (classified by Clavien-Dindo scale) between CHO-loaded and fasting groups. Investigate the impact on complications such as wound infections, pneumonia, ileus, renal failure, septic shock, and MODS. 2. Secondary: Compare change in NRL between groups. Assess the time to discharge based on criteria such as return of bowel function, tolerance to diet, pain management, and absence of infections.
Study Design: Type: Randomized Controlled Trial (RCT). Sample Size: 68 patients (34 in each group). Study Groups: Control: Conventional preoperative fasting. Intervention: CHO group receives maltodextrin drink (400ml night before and 200ml 2 hours before surgery). Randomization: Block randomization with concealed allocation. Blinding: Not involved.
Methodology: 1. Preoperative assessment includes demographic data and baseline NLR. 2. Both groups undergo standard preoperative treatments. 3. Postoperative complications monitored for 30 days. 4. NLR measured on postoperative days 1, 3, and 5. 5. Time to discharge evaluated using standardized criteria.
Statistical Analysis: Continuous variables: Mean/Median (Student’s t-test/Mann-Whitney test). Categorical variables: Chi-square/Fisher’s exact test. Multivariable analysis for risk assessment.
Expected Outcomes: CHO loading is hypothesized to reduce complications and improve postoperative recovery. Lower change in NRL in the CHO group suggests reduced systemic inflammation. Shorter hospital stay and fewer severe complications expected in the intervention group.
Ethical Considerations: Risks include multiple venous samplings. Precautions taken for potential adverse effects.
Conclusion:
This study aims to establish CHO loading as a cost-effective and beneficial intervention in colorectal cancer surgery by assessing its impact on complications, inflammation, and hospital stay duration. |