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Preoperative Carbohydrate Loading in Bariatric Surgery

Primary Purpose

Obesity, Morbid

Status
Unknown status
Phase
Phase 4
Locations
Poland
Study Type
Interventional
Intervention
Nutricia PreOp
Sponsored by
Medical University of Gdansk
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Obesity, Morbid focused on measuring bariatric surgery, carbohydrate loading, insulin resistance

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Department of General, Endocrine and Transplant Surgery Medical University of GdańskRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Carbohyrate loading

Fasting

Arm Description

Group A will receive 400ml of the carbohydrate rich drink, Nutricia preOp 2 hours before operation. This is the intervention group.

Group B will be prepared before the operation with a 24-hour fasting. This is the current clinical standard.

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

HOMA-IR
changes in insulin resistance will be assessed with HOMA index (Homeostatic Model Assessment for Insulin Resistance)
Body composition
changes in body composition will be assessed by electric bioimpedance method
Length of hospital stay
length of stay record in hours

Full Information

First Posted
July 12, 2020
Last Updated
July 21, 2020
Sponsor
Medical University of Gdansk
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1. Study Identification

Unique Protocol Identification Number
NCT04486079
Brief Title
Preoperative Carbohydrate Loading in Bariatric Surgery
Official Title
Preoperative Carbohydrate Loading in Bariatric Surgery - Randomized Clinical Trail
Study Type
Interventional

2. Study Status

Record Verification Date
July 2020
Overall Recruitment Status
Unknown status
Study Start Date
July 20, 2020 (Anticipated)
Primary Completion Date
July 20, 2021 (Anticipated)
Study Completion Date
October 31, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Medical University of Gdansk

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity, Morbid
Keywords
bariatric surgery, carbohydrate loading, insulin resistance

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
400 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Carbohyrate loading
Arm Type
Experimental
Arm Description
Group A will receive 400ml of the carbohydrate rich drink, Nutricia preOp 2 hours before operation. This is the intervention group.
Arm Title
Fasting
Arm Type
No Intervention
Arm Description
Group B will be prepared before the operation with a 24-hour fasting. This is the current clinical standard.
Intervention Type
Dietary Supplement
Intervention Name(s)
Nutricia PreOp
Intervention Description
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.
Primary Outcome Measure Information:
Title
QoR40 score
Description
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)
Time Frame
1st postoperatie day
Secondary Outcome Measure Information:
Title
HOMA-IR
Description
changes in insulin resistance will be assessed with HOMA index (Homeostatic Model Assessment for Insulin Resistance)
Time Frame
first assay one month before the operation, the second assay on the first postoperative day
Title
Body composition
Description
changes in body composition will be assessed by electric bioimpedance method
Time Frame
first assay one month before the operation, the second assay on the first postoperative day
Title
Length of hospital stay
Description
length of stay record in hours
Time Frame
From the time of hospital admission following surgery, until the time of hospital discharge; assessed from day of hospital admision up to 30 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Maciej Wilczyński
Phone
603383368
Email
mwilczynski@gumed.edu.pl
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Maciej Wilczyński
Organizational Affiliation
General Surgery Resident, PhD Fellow, Teaching Assistant
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of General, Endocrine and Transplant Surgery Medical University of Gdańsk
City
Gdańsk
State/Province
Pomerania
ZIP/Postal Code
80-214
Country
Poland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Maciej Wilczyński, doctor
Phone
603383368
Ext
+48
Email
mwilczynski@gumed.edu.pl

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
Medical University of Gdańsk will be the owner of data
Citations:
PubMed Identifier
31757437
Citation
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.
Results Reference
result
PubMed Identifier
30113392
Citation
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.
Results Reference
result
PubMed Identifier
28000931
Citation
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.
Results Reference
result
PubMed Identifier
26943657
Citation
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.
Results Reference
result

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Preoperative Carbohydrate Loading in Bariatric Surgery

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