Preoperative Administration of Oral Carbohydrate Drink, Neutrophil/Lymphocyte Ratio and Postoperative Complications
Condition: Neutrophil; Lymphocyte; Postoperative Complications
MeSH terms: Postoperative Complications
Study type: Interventional

Summary: 
      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.
    

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.
    

Intervention name(s): preoperative nutrition
Intervention type(s): Dietary Supplement
Intervention description(s): 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.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: The patients with diagnosed colon cancer were hospitalized and prepared for elective, open colon surgery at the Department of Surgery. Before surgical procedure, the patients were undergoing 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 (Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: fasting; carbohydrate; colorectal carcinoma; nutritional status