Study Results
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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UNKNOWN
PHASE4
400 participants
INTERVENTIONAL
2020-07-20
2021-10-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
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.
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.
Fasting
Group B will be prepared before the operation with a 24-hour fasting. This is the current clinical standard.
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.
Eligibility Criteria
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Inclusion Criteria
* No medical contraindications to perform a bariatric operation
* No contraindications for the use of a rich carbohydrate drink
Exclusion Criteria
* Age under 18 years
* The intolerance of the carbohydrate drink used in the test
* The contraindications to perform bioimpedance measurements of body composition
18 Years
ALL
No
Sponsors
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Medical University of Gdansk
OTHER
Responsible Party
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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
Countries
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Central Contacts
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Facility Contacts
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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.
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.
Other Identifiers
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PreOpxBariatric
Identifier Type: -
Identifier Source: org_study_id
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