Preoperative Administration of Oral Carbohydrate Drink, Neutrophil/Lymphocyte Ratio and Postoperative Complications

March 20, 2022 updated by: Nermina Rizvanović

Effects of Preoperative Oral Carbohydrate Loading on Neutrophil/Lymphocyte Ratio and Postoperative Complications Following Colorectal Cancer Surgery: a Randomized Controlled Study

This study evaluated the impact of a preoperative carbohydrate oral drink on the postoperative Neutrophil / Lymphocyte Ratio (NLR) and the incidence of postoperative complications after elective open colon surgery compared to the conventional preoperative fasting protocol. Hypothesis was: preoperative carbohydrate loading reduces postoperative NLR value and reduces the incidence and severity of postoperative complications in colorectal surgery.

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. The study protocol was approved by the local Ethics Committee.

A total of 60 participants who scheduled for elective open colon surgery and fulfilled study criteria were included into study. The purpose and procedures of the study were fully explained and voluntary, informed, written consent was obtained from each participant. The participants were randomly allocated into two equal groups, depending on the preoperative treatment. There were no reliable published data for effects of preoperative carbohydrate loading on postoperative NLR values. Based on our hypothesis, a pilot study was performed with ten patients per group. Mean postoperative NLR value was 8,67±4,98 in the participants with a conventional preoperative fasting protocol versus 4,76±2,83 in the participants with preoperative carbohydrate loading. 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 27 participants per group would be sufficient to detect a difference of 3,91 with a standard deviation of 4,93 in NLR value between the groups. Assuming dropout of 10%, 30 participants per group were included. Block randomization was used with a block size of six and a 1:1 group ratio. A computer-generated random numbers indicating preoperative intervention, were sealed in opaque envelopes. An investigator 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 in the Fasting group (control group) stopped oral intake at 12:00 pm the night before surgery and underwent to a conventional preoperative fasting protocol. Participants in the Carbohydrate group (experimental group) consumed 400 ml of a clear carbohydrate solution at 10:00 pm the night before surgery and 200 ml of a clear carbohydrate solution, 2 hours prior induction of anesthesia. All participants underwent general anesthesia followed by colorectal surgery.

Fasting peripheral venous blood samples were collected at 06:00 am on the day of surgery (basal value), at 06:00 am on the first postoperative day, at 06:00 am on the third postoperative day and at 06:00 am on the fifth postoperative day. White blood counts were analysed with automated differential counts. The NLR value was obtained by dividing the absolute neutrophil count and the absolute lymphocyte count. All participants were followed up to 30 days post-surgery to assess postoperative complications and readmission rate. After discharge, participants were called by phone, once a week. Postoperative complications were graded for incidence and severity using the Clavien-Dindo Classification of Surgical Complications.

Demographic and surgical data of the participants were recorded: 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 and duration of surgery.

Study Type

Interventional

Enrollment (Actual)

60

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 diagnosed colorectal carcinoma scheduled for elective open colorectal surgery
  • aged between 18 years and 70 years
  • participants with ASA physical status class I-III

Exclusion Criteria:

  • previous treatment of colon, rectum or any other cancer
  • emergency or palliative colon and rectum surgery
  • disseminated malignant disease
  • body mass index below 20 and above 30 kg/mᶺ2
  • overall score ≥3 after final assessment of the nutritional status according to Nutritional Risk Screening 2002 (NRS-2002)
  • disease with increased risk of aspiration
  • history of diabetes mellitus
  • history of hematological disease
  • evidence of systemic inflammation
  • immunomodulatory therapy
  • neuromuscular 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 Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Fasting group
conventional preoperative fasting protocol The participants in the Fasting group stopped oral intake at 12:00 pm, the night before surgery. After surgery the participants fasted until the recovery of function of the bowel.
Experimental: Carbohydrate group
preoperative nutrition The participants of experimental group consumed 400 ml of a clear carbohydrate drink (12,5 gr/100 ml carbohydrate, 50 kcal/100 ml, pH 5.0) at 10:00 pm the evening before surgery and 200 ml 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 consumed 400 ml of a clear carbohydrate drink (12,5 gr/100 ml carbohydrate, 50 kcal/100 ml, pH 5.0) at 10:00 pm the evening before surgery and 200 ml 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 NLR values between conventional preoperative fasting protocol and a preoperative carbohydrate loading
Time Frame: fasting peripheral venous blood samples were collected at 06:00 am on the day of surgery (basal value), at 06:00 am on the first postoperative day, at 06:00 am on the third postoperative day and at 06:00 am on the fifth postoperative day.
White blood counts with automated differential counts were analysed from peripheral venous blood samples using fluorescence flow cytometry method. The NLR value was calculated by following equation: NLR = the absolute neutrophil count (range of normality 4,0-7,0x10ᶺ9/L) / the absolute lymphocyte count (range of normality 1-3,7x10ᶺ9/L).
fasting peripheral venous blood samples were collected at 06:00 am on the day of surgery (basal value), at 06:00 am on the first postoperative day, at 06:00 am on the third postoperative day and at 06:00 am on the fifth postoperative day.
The mean change in delta NLR value between conventional preoperative fasting protocol and a preoperative carbohydrate loading
Time Frame: fasting peripheral venous blood samples were collected at 06:00 am on the day of surgery (basal value), at 06:00 am on the first postoperative day, at 06:00 am on the third postoperative day and at 06:00 am on the fifth postoperative day.
Delta NLR value was defined as dynamic change in NLR value from basal value to the highest measured post-surgery NLR value. Delta NLR was calculated using following equation: Delta NRL = the highest measured post-surgery NLR value - basal NLR value.
fasting peripheral venous blood samples were collected at 06:00 am on the day of surgery (basal value), at 06:00 am on the first postoperative day, at 06:00 am on the third postoperative day and at 06:00 am on the fifth postoperative day.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The mean change in incidence and severity of postoperative complications assessed using the Clavien-Dindo Classification of Surgical Complications between conventional preoperative fasting protocol and a preoperative carbohydrate loading
Time Frame: the incidence and severity of postoperative complications were assessed up to 30 days post-surgery. After discharge, participants were called by phone once a week and finally on the 30th day post-surgery.
Postoperative complications were graded as follow: Grade I considered any deviation from the normal course without the need for pharmacological treatment or surgical, endoscopic and radiologic interventions. Grade II required pharmacological treatment with drugs other than such allowed for Grade I complications. Grade I and Grade II were considered minor postoperative complications. Grade III required surgical, endoscopic or radiological intervention without or with general anesthesia. Grade IV considered life-threatening complication required intensive care unit management. Grade V included death of patient. Grade III, IV and V were considered major complications.
the incidence and severity of postoperative complications were assessed up to 30 days post-surgery. After discharge, participants were called by phone once a week and finally on the 30th day post-surgery.
The mean change in characteristics of postoperative complications between conventional preoperative fasting protocol and a preoperative carbohydrate loading
Time Frame: the characteristics of postoperative complications and readmission rate were assessed up to 30 days post-surgery. After discharge, participants were called by phone once a week and finally on the 30th day post-surgery.
Characteristics of postoperative complications included: overall number of complications per group, number of participants without complications per group, number of participants with complications per group, number of participants with 1 complication per group, number of participants with 2 complications per group, number of participants with >2 complications per group and readmission rate per group within 30 days post-surgery.
the characteristics of postoperative complications and readmission rate were assessed up to 30 days post-surgery. After discharge, participants were called by phone once a week and finally on the 30th day 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, PhD, 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 4, 2020

Primary Completion (Actual)

December 20, 2021

Study Completion (Actual)

January 20, 2022

Study Registration Dates

First Submitted

March 20, 2022

First Submitted That Met QC Criteria

March 20, 2022

First Posted (Actual)

March 31, 2022

Study Record Updates

Last Update Posted (Actual)

March 31, 2022

Last Update Submitted That Met QC Criteria

March 20, 2022

Last Verified

March 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NR03/22

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.

Clinical Trials on Postoperative Complications

Clinical Trials on preoperative nutrition

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Gabon

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe