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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Carbohyrate loading | Experimental | Group A will receive 400ml of the carbohydrate rich drink, Nutricia preOp 2 hours before operation. This is the intervention group. |
|
| Fasting | No Intervention | Group B will be prepared before the operation with a 24-hour fasting. This is the current clinical standard. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nutricia PreOp | 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. |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Maciej Wilczyński | Contact | 603383368 | mwilczynski@gumed.edu.pl |
| Name | Affiliation | Role |
|---|---|---|
| Maciej Wilczyński | General Surgery Resident, PhD Fellow, Teaching Assistant | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of General, Endocrine and Transplant Surgery Medical University of Gdańsk | Recruiting | Gdansk | Pomeranian Voivodeship | 80-214 | Poland |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31757437 | Result | 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. | |
| 30113392 | Result | 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. |
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Medical University of Gdańsk will be the owner of data
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| ID | Term |
|---|---|
| D009767 | Obesity, Morbid |
| D007333 | Insulin Resistance |
| ID | Term |
|---|---|
| D009765 | Obesity |
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
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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 |
| 28000931 | Result | 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. |
| 26943657 | Result | 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. |
| D009750 |
| Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D006946 | Hyperinsulinism |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |