Clinical trial NCT04486079: Preoperative Carbohydrate Loading in Bariatric Surgery
Official title: Preoperative Carbohydrate Loading in Bariatric Surgery - Randomized Clinical Trail
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Obesity, Morbid
Keywords: bariatric surgery
carbohydrate loading
insulin resistance
Lead sponsor: Medical University of Gdansk
Sponsor class: OTHER
First posted: 2020-07-24
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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


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

Primary outcomes:
measure: QoR40 score
timeFrame: 1st postoperatie day
Secondary outcomes:
measure: HOMA-IR
timeFrame: first assay one month before the operation, the second assay on the first postoperative day
measure: Body composition
timeFrame: first assay one month before the operation, the second assay on the first postoperative day
measure: Length of hospital stay
timeFrame: From the time of hospital admission following surgery, until the time of hospital discharge; assessed from day of hospital admision up to 30 days
Other outcomes:
Locations:
city: Gdańsk
country: Poland
facility: Department of General, Endocrine and Transplant Surgery Medical University of Gdańsk
state: Pomerania
Study officials:
affiliation: General Surgery Resident, PhD Fellow, Teaching Assistant
name: Maciej Wilczyński
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.
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.