Preoperative Carbohydrate Loading in Bariatric Surgery

Preoperative Carbohydrate Loading in Bariatric Surgery - Randomized Clinical Trail

The aim of this study is to perform a randomized non-blinded clinical trial to assess influence of preoperative carbohydrates loading in patients undergoing bariatric surgery measured by changes in the course of the postoperative period, changes in body composition and changes in insulin resistance

Study Overview

• Status: Unknown
• Conditions: Obesity, Morbid
• Intervention / Treatment: Dietary supplement: Nutricia PreOp

• Study Type: Interventional
• Enrollment (Anticipated): 400
• Phase: Phase 4

Contacts and Locations

Study Locations

• Poland
  • Pomerania
    • Gdańsk, Pomerania, Poland, 80-214
      • Recruiting
      • Department of General, Endocrine and Transplant Surgery Medical University of Gdańsk
      • Contact: Maciej Wilczyński, doctor; Phone Number: +48 603383368; Email: mwilczynski@gumed.edu.pl

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Obtaining written and informed patient consent.
• No medical contraindications to perform a bariatric operation
• No contraindications for the use of a rich carbohydrate drink

Exclusion Criteria:

• No consent to participate in the study
• Age under 18 years
• The intolerance of the carbohydrate drink used in the test
• The contraindications to perform bioimpedance measurements of body composition

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Carbohyrate loading; Group A will receive 400ml of the carbohydrate rich drink, Nutricia preOp 2 hours before operation. This is the intervention group.	Dietary supplement: Nutricia PreOp; A clear, non-carbonated lemon-flavored, iso-osmolar carbohydrate drink for preoperative surgical patients. Used in studies supporting the Enhanced Recovery After Surgery (ERAS) Society Consensus Guidelines.
No Intervention: Fasting; Group B will be prepared before the operation with a 24-hour fasting. This is the current clinical standard.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
QoR40 score	Quality of recovery after surgery will be assessed by the QoR40 survey Full scale title: Quality of Recovery 40-item questionnaires range from 40 (extremely poor. quality of recovery) to 200 (excellent quality of recovery)	1st postoperatie day

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
HOMA-IR	changes in insulin resistance will be assessed with HOMA index (Homeostatic Model Assessment for Insulin Resistance)	first assay one month before the operation, the second assay on the first postoperative day
Body composition	changes in body composition will be assessed by electric bioimpedance method	first assay one month before the operation, the second assay on the first postoperative day
Length of hospital stay	length of stay record in hours	From the time of hospital admission following surgery, until the time of hospital discharge; assessed from day of hospital admision up to 30 days

Collaborators and Investigators

• Sponsor: Medical University of Gdansk
• Investigators: Principal Investigator: Maciej Wilczyński, General Surgery Resident, PhD Fellow, Teaching Assistant

Publications and helpful links

General Publications

• Knight P, Chou J, Dusseljee M, Verseman S, Elian A. Effective reduction in stress induced postoperative hyperglycemia in bariatric surgery by better carb loading. Am J Surg. 2020 Mar;219(3):396-398. doi: 10.1016/j.amjsurg.2019.10.042. Epub 2019 Nov 9.
• Grant MC, Gibbons MM, Ko CY, Wick EC, Cannesson M, Scott MJ, McEvoy MD, King AB, Wu CL. Evidence Review Conducted for the Agency for Healthcare Research and Quality Safety Program for Improving Surgical Care and Recovery: Focus on Anesthesiology for Bariatric Surgery. Anesth Analg. 2019 Jul;129(1):51-60. doi: 10.1213/ANE.0000000000003696.
• Amer MA, Smith MD, Herbison GP, Plank LD, McCall JL. Network meta-analysis of the effect of preoperative carbohydrate loading on recovery after elective surgery. Br J Surg. 2017 Feb;104(3):187-197. doi: 10.1002/bjs.10408. Epub 2016 Dec 21.
• Thorell A, MacCormick AD, Awad S, Reynolds N, Roulin D, Demartines N, Vignaud M, Alvarez A, Singh PM, Lobo DN. Guidelines for Perioperative Care in Bariatric Surgery: Enhanced Recovery After Surgery (ERAS) Society Recommendations. World J Surg. 2016 Sep;40(9):2065-83. doi: 10.1007/s00268-016-3492-3.

Study record dates

Study Major Dates

• Study Start (Anticipated): July 20, 2020
• Primary Completion (Anticipated): July 20, 2021
• Study Completion (Anticipated): October 31, 2021

Study Registration Dates

• First Submitted: July 12, 2020
• First Submitted That Met QC Criteria: July 21, 2020
• First Posted (Actual): July 24, 2020

Study Record Updates

• Last Update Posted (Actual): July 24, 2020
• Last Update Submitted That Met QC Criteria: July 21, 2020
• Last Verified: July 1, 2020

More Information

Terms related to this study

• Keywords: bariatric surgery; insulin resistance; carbohydrate loading
• Additional Relevant MeSH Terms: Overnutrition; Nutrition Disorders; Overweight; Body Weight; Obesity; Obesity, Morbid
• Other Study ID Numbers: PreOpxBariatric

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: Medical University of Gdańsk will be the owner of data

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No