Kelulut Honey as an Alternate Source of Carbo-Loading in Abdominal Surgery Involving the Digestive System

Overview

The study aims to identify if Kelulut Honey can be a potential alternative for the use of preoperative carboloading instead of the commercially available product, Carborie.

Full Title of Study: “The Use of Kelulut Honey for Carbohydrate-Loading in the Preoperative Period for Patients Undergoing Abdominal Surgery Involving the Digestive System as Part of Enhanced Recovery After Surgery as Opposed to VALENS® Carborie®Load”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  • Study Primary Completion Date: December 2021

Detailed Description

Enhanced Recovery After Surgery is a well-established, evidence based multimodal, multidisciplinary approach to the care of the surgical patient. The aim of the program, as per its nomenclature, is to establish a set of protocol to subject the surgical patient to in order to facilitate recovery, attenuate the metabolic responses from surgery, reduce complications and ultimately reduce length of stay as well as establish return of physiological function of the patient in an accelerated fashion.

As mentioned, given that ERAS involves a multimodal, multidisciplinary approach, there are many aspects and guidelines as to the implementation of ERAS. One particular modern care change is conversion of the surgical dogma of overnight fasting to carbo-loading; whereby the patient is subjected to consume a carbohydrate rich drink the evening prior to surgery, and 2 hours prior to induction with anaesthesia. The doctrine of overnight fasting or rather 6-8 hours of fasting has long been the core principal for many anaesthesiologists and surgeons, given the rationale that this would reduce gastric acidity and volume, thereby reducing the risk of vomiting and gastric content aspiration. However, modern guidelines have shown that there are no evidence that shortened fast of 2-3 of oral fluids increase the risk of aspiration, regurgitation or increase morbidity as compared with fasting after midnight.

The problem with fasting, is that it increases insulin resistance. In line with acute-phase response, and loss of lean body mass, this will attenuate the affects of prolonged fasting. So, in an insulin resistant state, cell glucose uptake is reduced, and therefore glycogen formation reduces, which means, the liver and muscle glycogen storage are depleted. Hyperglycaemia ensues, due to the enhanced endogenous glucose production. Glucose control needs to be adequate to avoid risk of surgical complication and mortality.

The benefits of carbo-loading is well documented and the evidence is overwhelming. The evidence shows that oral ingestion of 50g of Carbohydrate has been shown to release Insulin similar to that of a mixed meal. The current guideline advocates 100g of carbohydrate consumed the evening prior to surgery and another 50g 2 hours before surgery. The first dose is consumed with 800 mL of water, and the subsequent dose with 400mL.

Kelulut honey is a natural product, which contains sugar in the form of fructose and glucose produced by bees (Meliponini Sp). They have a rapid onset, as they are freely absorbed into the blood stream without requiring digestion. Honey also has a proven role in facilitating wound healing, and as an anti-inflammatory, and antibacterial agent. The aim of this study is to evaluate the use of honey as an alternative to maltodextrin extract for carbo-loading in patients undergoing elective gastrointestinal surgery (Upper GI and Lower GI) and its effects.

Interventions

  • Dietary Supplement: Kelulut Honey
    • The Substance being tested to be used as an alternative
  • Dietary Supplement: Carborie
    • The commercially available substance

Arms, Groups and Cohorts

  • Experimental: Kelulut Honey
    • Medical Grade Kelulut Honey which will be in 2 doses. The first would be diluted to 800 ml of water, and the second dose in 400ml of water.
  • Active Comparator: Carborie
    • Carborie Load which will be 100g of carbohydrate in 800 ML of water and 50g of carbohydrate in 400ml of water.

Clinical Trial Outcome Measures

Primary Measures

  • Kelulut Honey Improves Insulin Resistance when used as carbo-loading preoperatively
    • Time Frame: 48 Hours
    • • To compare blood sugar levels between patients receiving Kelulut Honey and Carborie pre, intra, and post operatively.
  • Kelulut Honey would be completely cleared within 2 hours after consumption when used for carbo-loading preoperatively.
    • Time Frame: 2 hours
    • • To compare Residual Gastric Volume between patients receiving Kelulut Honey and Carborie preoperatively.

Participating in This Clinical Trial

Inclusion Criteria

  • Adult (Age ≥ 18)
  • Elective Surgery with Intraabdominal Involvement

Exclusion Criteria

  • Known Diabetics
  • Fasting Glucose Level > 7 mmol/L
  • ASA > 3
  • On Steroid Treatment
  • Recent Infection Past 3 Months
  • Preoperative Unintentional Weight Loss >10% of usual body weight within 6 months
  • Emergency Surgery
  • Minor (Age < 18)

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Universiti Sains Malaysia
  • Provider of Information About this Clinical Study
    • Principal Investigator: B. Karthik Krishnan, Principal Investigator – Universiti Sains Malaysia
  • Overall Contact(s)
    • Karthik Krishnan, M.D., 0163770251, doctorkarthik@gmail.com

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