Preoperative Administration of Oral Carbohydrate Drink and Postoperative Insulin Resistance

January 3, 2019 updated by: Nermina Rizvanović

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Study Type

Interventional

Enrollment (Actual)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: TRIPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
NO_INTERVENTION: FAST group
preoperative fasting
EXPERIMENTAL: CHO group
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
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.

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
Time Frame: 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.
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.
Time Frame: 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 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
Time Frame: 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 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
Time Frame: 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
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
Time Frame: from 24 hours post-surgey from apprroximately 10 days post-surgery
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Nermina Rizvanović

Investigators

  • Principal Investigator: Nermina Rizvanović, MD, Cantonal Hospital Zenica, Crkvice 67, 72 000 Zenica, Bosnia and Herzegovina

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

May 1, 2018

Primary Completion (ACTUAL)

December 20, 2018

Study Completion (ACTUAL)

December 31, 2018

Study Registration Dates

First Submitted

January 2, 2019

First Submitted That Met QC Criteria

January 2, 2019

First Posted (ACTUAL)

January 4, 2019

Study Record Updates

Last Update Posted (ACTUAL)

January 7, 2019

Last Update Submitted That Met QC Criteria

January 3, 2019

Last Verified

January 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NR01/19

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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