Preoperative Administration of Oral Carbohydrate Drink and Postoperative Insulin Resistance

Study Overview
=================
Brief Summary
-----------------
This study compared traditional concept of preoperative fasting before elective open colon surgery and preoperative treatment with carbohydrate oral drink in intention to improve postoperative stress response to surgical procedure. Hypothesis was: preoperative oral carbohydrate drink reduces postoperative insulin resistance, improves insulin sensitivity, reduces postoperative inflammatory response in terms of the value of Glasgow Prognostic Score (GPS) and IL-6, improves postoperative patient's subjective well-being and surgical clinical outcome.

Detailed Description
-----------------
This prospective randomized, controlled clinical study was carried out in the Department of Anesthesiology and Intensive Care Unit and Department of Surgery at the Cantonal Hospital Zenica, Bosnia and Herzegovina. After obtaining ethical committee approval 50 participants, scheduled for elective open colon surgery were included into study. Sample size was estimated using sample size calculator software and power analysis with 95% confidence interval and power of 80%. Statistical significance was considered as p< 0,05. The calculation indicated 19 participants per group would be sufficient to detect a 50% difference for insulin resistance between the groups. Assuming dropout would lead to a total sample size of 50 participants. Before each participant agreed to the join the study, the purpose and procedures of the study were fully explained and informed and written consent was obtained from each participant. A preoperative anesthetic examination was conducted the day before surgery. The participants who fulfilled study criteria were randomly allocated into two groups of 25 participants, depending on the preoperative treatment. The intervention group, received preoperative carbohydrate oral supplementation (CHO group) and the control group (FAST group) underwent to a conventional routine of preoperative fasting. Randomization was performed by computer generated randomization codes. The codes which indicated the treatment were held in sealed opaque envelopes. Nurse who conducted randomization and opened the envelopes the night before surgery was blinded to the study protocol as well as the surgeons, nurses, anesthesiologists and staff involved in data collection. The participants of FAST group were undergone to the traditional concept of preoperative fasting before surgical procedure. The participants in the intervention group received carbohydrate oral supplement at 10:00 pm the evening before surgery and again on the day of surgery, 2 hours before induction of anesthesia. Assessment of clinical parameters started at 06:00 am on the day of surgery (basal value). The fasting peripheral venous blood samples were collected to measure serum levels of glucose, insulin, C-reactive protein, albumin and IL-6, and further 6 hours post-surgery, at 06.00 am on the first postoperative day and at 06:00 am on the second postoperative day. All patients underwent general anesthesia followed by colon surgery. Assessment of subjective well-being was performed immediately before induction into anesthesia using a 10 cm horizontal Visual Analogue Scales and then repeated for 0-4, 4-8, 8-12 and 12-24 hours post-surgery. Pain at rest, pain with mobilization, thirst, hunger, mouth dryness, anxiety and weakness were evaluated. The patients were explained how to use the scale. Surgical outcome was evaluated by postoperative return of gastrointestinal function, time to independent ambulation and postoperative discharge day. Postoperative data included and the time to oral intake. The following data were recorded also: age, sex, body weight, body mass index, American Society of Anesthesiologists (ASA) physical status class, nutritional status of the participants according to Nutritional Risk Screening 2002 (NRS-2002), tumor localization, type of surgery, duration of surgery, preoperative fasting time and, blood loss during surgery

Official Title
-----------------
A Randomized Controlled Study of Preoperative Oral Carbohydrate Loading Versus Fasting in Patients Undergoing Colorectal Surgery

Conditions
-----------------
Insulin Resistance, Inflammatory Response, Exaggerated Well-Being, Length of Stay

Intervention / Treatment
-----------------
* Dietary Supplement: preoperative nutrition


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: participants with ASA physical status class I-II aged between 18 years and 70 years participants scheduled for elective open colon surgery Exclusion Criteria: previous treatment of colon or any other cancer disseminated malignant disease gastro-oesophageal reflux or increased risk of aspiration body mass index below 20 and above 30 kg/m2 overall score ≥3 after final assessment of the nutritional status according to Nutritional Risk Screening 2002 (NRS-2002) emergency colon surgery diabetes mellitus inflammatory bowel disease immunological therapy cardiopulmonary disease neuromusular disease renal disease hepatic or endocrine disease pregnancy mental disease allergy to any study drugs alcoholic or drug abuse patient's refusal to participate in the study.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: The diagnostic protocol for colon cancer was performed in patients at the surgery department. The patients with diagnosed colon tumor were prepared for the surgical procedure. After that, patients were examined to a preoperative anesthetic visit. During the visit, participants were assessed according to eligibility for enrollment in the study. The participants who have met the eligibility criteria have explained the nature of the study protocol. Those who agreed to participate in the study were randomized to one of two study groups for the duration of the study.
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: FAST group<br>preoperative fasting | |
| Experimental: CHO group<br>preoperative nutrition The participants of experimental group received 400 mil of a clear carbohydrate drink (12,5 gr/100 mil carbohydrate, 50 kcal/100ml, pH 5.0) at 10:00 pm the evening before surgery and another 200 mil of the carbohydrate drink on the day of surgery, 2 hours before induction of anesthesia. After surgery the participants fasted until the recovery of function of the bowel. | Dietary Supplement: preoperative nutrition<br>* The participants of experimental group received 400 mil of a clear carbohydrate drink (12,5 gr/100 mil carbohydrate, 50 kcal/100ml, pH 5.0) at 10:00 pm the evening before surgery and another 200 mil of the carbohydrate drink on the day of surgery, 2 hours before induction of anesthesia. After surgery the participants fasted until the recovery of function of the bowel.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The mean change in insulin resistance using computer model Homeostasis model assessment of insulin resistance | Blood samples were collected to measure serum levels of glucose and serum levels of insulin. Insulin resistance, was calculated according to the equation = [fasting insulin (µU/ml) x fasting glucose (mmol/L)] / 22,5 using computer model Homeostasis model assessment of insulin resistance 2 Calculator version 2,2. The value >1 indicated the presence of resistance to insulin. | blood samples were taken at 06:00 am on the day of surgery ( basal value), 6 hours post-surgery, at 06.00 am on the first postoperative day and at 06:00 am on the second postoperative day. | 
| The mean change in Glasgow Prognostic Score (GPS). The GPS was obtained as ratio of serum C-reactive protein/albumin. | The GPS was calculated as follow: participants with elevated level of C-reactive protein >10mg/L and albumin <35 g/L were allocated a score of 2. Participants showing one or neither of these blood chemistry abnormalities were allocated a score 1 or 0. | blood samples were taken at four time points: at 06:00 am on the day of surgery ( basal value), 6 hours post-surgery, at 06.00 am on the first postoperative day and at 06:00 am on the second postoperative day. | 
| The mean change in serum level of IL-6 | The concentration of IL-6 in serum has a r.n. 0-5,9 pg/mL. | blood samples were taken at four time points: at 06:00 am on the day of surgery ( basal value), 6 hours post-surgery, at 06.00 am on the first postoperative day and at 06:00 am on the second postoperative day. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The mean change from baseline in participant's subjective well-being score on Visual Analogue Scale | The participant's subjective well-being included: pain at rest and with movement, thirst, hunger, dry mouth, weakness, anxiety, nausea and vomiting. The mean change were measured using a 10 cm horizontal Visual Analogue Scale. The scales were undivided and limited at both ends by vertical lines. The left end represented no symptom (score:0) and the right end represented the worst imaginable (score 100) limits of the variable to be evaluated. The participants rated discomfort by marking on the scales line at the point that represented their level of perceived symptom. The distance on the scales line from score 0 to the patient's mark determined the score of symptom intensity. The score was calculated as follow: 0-1cm no symptom; 1-3 cm mild symptom; 3-7 cm moderate symptom; 7-10 cm strong symptom. The patients were questioned about presence of nausea and vomiting at five study time points. A NO answer was grade as 1 and a YES answer was graded as 2. | The assessment of subjective well-being and pain score was performed immediately before induction into anesthesia and then repeated for 0-4, 4-8, 8-12 and 12-24 hours post-surgery | 
| surgical clinical outcomes | Surgical clinical outcomes included postoperative return of gastrointestinal function, time to independent ambulation and postoperative discharge day. The return of gastrointestinal function was assessed as follow: the sounds of the bowel were detected by an abdominal auscultation 24, 36, 48, 60, 72 and 80 hours after surgery. The time of the first postoperative flatus and defecation were recorded as well as the time to postoperative oral intake. | from 24 hours post-surgey from apprroximately 10 days post-surgery | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
fasting, carbohydrate, insulin resistance