Preoperative Carbohydrate Loading in Bariatric Surgery

NCT ID: NCT04486079

Last Updated: 2020-07-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

400 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-07-20

Study Completion Date

2021-10-31

Brief Summary

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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

Detailed Description

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Conditions

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Obesity, Morbid

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Carbohyrate loading

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

Group Type EXPERIMENTAL

Nutricia PreOp

Intervention Type DIETARY_SUPPLEMENT

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.

Fasting

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Medical University of Gdansk

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Maciej Wilczyński

Role: PRINCIPAL_INVESTIGATOR

General Surgery Resident, PhD Fellow, Teaching Assistant

Locations

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Department of General, Endocrine and Transplant Surgery Medical University of Gdańsk

Gdansk, Pomeranian Voivodeship, Poland

Site Status RECRUITING

Countries

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Poland

Central Contacts

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Maciej Wilczyński

Role: CONTACT

603383368

Facility Contacts

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Maciej Wilczyński, doctor

Role: primary

603383368 ext. +48

References

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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.

Reference Type RESULT
PMID: 31757437 (View on PubMed)

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.

Reference Type RESULT
PMID: 30113392 (View on PubMed)

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.

Reference Type RESULT
PMID: 28000931 (View on PubMed)

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.

Reference Type RESULT
PMID: 26943657 (View on PubMed)

Other Identifiers

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PreOpxBariatric

Identifier Type: -

Identifier Source: org_study_id

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