Abdominal Aortic Aneurysm Clinical Trial
Official title:
Preoperative Oral Carbohydrate Loading in Aortic Surgery
The adverse effects of overnight fasting before surgery have been well-documented in the contemporary literature. Still, due to the possibility of pulmonary aspiration of gastric contents, many clinicians worldwide still employ this practice. On the other hand, the benefits of preoperative oral carbohydrate loading (OCHL) have been shown in various patient groups. Studies examining the usefulness of preoperative OCHL in aortic surgery are lacking. In particular, no randomized control trials have specifically examined the impact of preoperative OCHL on the postoperative course in patients undergoing open abdominal aortic surgery.
Status | Not yet recruiting |
Enrollment | 50 |
Est. completion date | November 1, 2024 |
Est. primary completion date | October 1, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 40 Years to 90 Years |
Eligibility | Inclusion Criteria: - Consecutive patients admitted due to elective surgical treatment of abdominal aortic aneurism or Leriche Syndrome. - Patients scheduled to be operated on first on a given day, that is, patients whose surgery will be performed first in the morning. - Personally signed informed consent. Exclusion Criteria: - Patients with diabetes or fasting glucose level above seven mmol/L; - Patients with disorders that prolong gastric emptying (gastroesophageal reflux disease, history of gastrointestinal surgery, hiatus hernia or intestinal obstruction); - Patients with conditions that could potentially prolong the postoperative recovery (severe physical disability, cognitive impairment, autoimmune diseases, severe infection, significant liver and renal failure, or severe psychiatric/mental disorders); - Patients with alcohol/drug abuse - Obese patients with obesity class 3 (BMI = 40 kg/m2); - Patients undergoing emergent surgery; - Patients treated with immunosuppressants and/or steroids in the past three months before surgery; - Patients in whom difficult airway is anticipated. |
Country | Name | City | State |
---|---|---|---|
Serbia | Clinic for Vascular and Endovascular Surgery, University Clinical Center of Serbia | Belgrade |
Lead Sponsor | Collaborator |
---|---|
University of Belgrade |
Serbia,
Cheng PL, Loh EW, Chen JT, Tam KW. Effects of preoperative oral carbohydrate on postoperative discomfort in patients undergoing elective surgery: a meta-analysis of randomized controlled trials. Langenbecks Arch Surg. 2021 Jun;406(4):993-1005. doi: 10.1007/s00423-021-02110-2. Epub 2021 Feb 25. — View Citation
Joshi GP, Abdelmalak BB, Weigel WA, Harbell MW, Kuo CI, Soriano SG, Stricker PA, Tipton T, Grant MD, Marbella AM, Agarkar M, Blanck JF, Domino KB. 2023 American Society of Anesthesiologists Practice Guidelines for Preoperative Fasting: Carbohydrate-containing Clear Liquids with or without Protein, Chewing Gum, and Pediatric Fasting Duration-A Modular Update of the 2017 American Society of Anesthesiologists Practice Guidelines for Preoperative Fasting. Anesthesiology. 2023 Feb 1;138(2):132-151. doi: 10.1097/ALN.0000000000004381. — View Citation
Liu B, Wang Y, Liu S, Zhao T, Zhao B, Jiang X, Ye L, Zhao L, Lv W, Zhang Y, Zheng T, Xue Y, Chen L, Chen L, Wu Y, Li Z, Yan J, Wang S, Sun X, Gao G, Qu Y, He S. A randomized controlled study of preoperative oral carbohydrate loading versus fasting in patients undergoing elective craniotomy. Clin Nutr. 2019 Oct;38(5):2106-2112. doi: 10.1016/j.clnu.2018.11.008. Epub 2018 Nov 17. — View Citation
Nygren J, Thorell A, Jacobsson H, Larsson S, Schnell PO, Hylen L, Ljungqvist O. Preoperative gastric emptying. Effects of anxiety and oral carbohydrate administration. Ann Surg. 1995 Dec;222(6):728-34. doi: 10.1097/00000658-199512000-00006. — View Citation
Nygren J. The metabolic effects of fasting and surgery. Best Pract Res Clin Anaesthesiol. 2006 Sep;20(3):429-38. doi: 10.1016/j.bpa.2006.02.004. — View Citation
Rizvanovic N, Nesek Adam V, Causevic S, Dervisevic S, Delibegovic S. A randomised controlled study of preoperative oral carbohydrate loading versus fasting in patients undergoing colorectal surgery. Int J Colorectal Dis. 2019 Sep;34(9):1551-1561. doi: 10.1007/s00384-019-03349-4. Epub 2019 Jul 15. — View Citation
Smith I, Kranke P, Murat I, Smith A, O'Sullivan G, Soreide E, Spies C, in't Veld B; European Society of Anaesthesiology. Perioperative fasting in adults and children: guidelines from the European Society of Anaesthesiology. Eur J Anaesthesiol. 2011 Aug;28(8):556-69. doi: 10.1097/EJA.0b013e3283495ba1. — View Citation
Sun J, Wei G, Hu L, Liu C, Ding Z. Perioperative pulmonary aspiration and regurgitation without aspiration in adults: a retrospective observational study of 166,491 anesthesia records. Ann Palliat Med. 2021 Apr;10(4):4037-4046. doi: 10.21037/apm-20-2382. Epub 2021 Mar 23. — View Citation
Weimann A, Braga M, Carli F, Higashiguchi T, Hubner M, Klek S, Laviano A, Ljungqvist O, Lobo DN, Martindale R, Waitzberg DL, Bischoff SC, Singer P. ESPEN guideline: Clinical nutrition in surgery. Clin Nutr. 2017 Jun;36(3):623-650. doi: 10.1016/j.clnu.2017.02.013. Epub 2017 Mar 7. — View Citation
Xu D, Zhu X, Xu Y, Zhang L. Shortened preoperative fasting for prevention of complications associated with laparoscopic cholecystectomy: a meta-analysis. J Int Med Res. 2017 Feb;45(1):22-37. doi: 10.1177/0300060516676411. Epub 2017 Jan 12. — View Citation
Zhou G, Zhu F, An Y, Qin L, Lv J, Zhao X, Shen J. Prolonged preoperative fasting and prognosis in critically ill gastrointestinal surgery patients. Asia Pac J Clin Nutr. 2020;29(1):41-47. doi: 10.6133/apjcn.202003_29(1).0006. — View Citation
* Note: There are 11 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | The ICU length of stay | The ICU length of stay will be defined as the interval from the end of surgery to the date of ICU discharge. | up to 10 days following surgery | |
Primary | Homeostatic Model Assessment for Insulin Resistance (HOMA-IR) | Values of glucose and serum insulin will be assessed at four time-points: T1, 9-11 p.m. in the evening before the surgery (before high-carbohydrate beverage in OCHL group); T2 90 min after high-carbohydrate beverage ingestion in OCHL group, i.e., at 06 a.m. in the control group, on the day of the surgery; T3 6 h following the surgery, and T4 06 a.m. on the postoperative day 1. Values of HOMA-IR will be subsequently calculated for each of the four time points. | 1 day preoperatively - 1 day following surgery | |
Primary | Insulin sensitivity index (HOMA-ISI) | Values of glucose and serum insulin will be assessed at four time-points: T1, 9-11 p.m. in the evening before the surgery (before high-carbohydrate beverage in OCHL group); T2 90 min after high-carbohydrate beverage ingestion in OCHL group, i.e. at 06 a.m. in the control group, on the day of the surgery; T3 6 h following the surgery, and T4 06 a.m. on the postoperative day 1. Values of HOMA-ISI will be subsequently calculated for each of the four time points. | 1 day preoperatively - 1 day following surgery | |
Primary | Homeostasis model assessment of ß-cell function (HOMA-ß) | Values of glucose and serum insulin will be assessed at four time-points: T1, 9-11 p.m. in the evening before the surgery (before high-carbohydrate beverage in OCHL group); T2 90 min after high-carbohydrate beverage ingestion in OCHL group, i.e. at 06 a.m. in the control group, on the day of the surgery; T3 6 h following the surgery, and T4 06 a.m. on the postoperative day 1. Values of HOMA-ß will be subsequently calculated for each of the four time points. | 1 day preoperatively - 1 day following surgery | |
Primary | Six aspects of subjective well-being according to the visual analog scale | The variables of the subjective well-being will be evaluated in several time points: in the morning before the surgery, 6-12h following the surgery and 24h following the surgery. The minimum score is zero, and the maximum score is 10. The higher the score, the worse the outcome. | preoperatively - 1 day following surgery | |
Secondary | Length of hospital stay | Length of hospital stay will be defined as the interval from the admission to the hospital to the date of hospital discharge. | From the date of hospital admission until the date of hospital discharge or date of death from any cause, whichever came first, assessed up to two months following surgery. | |
Secondary | 30-day mortality rate | 30-day mortality would refer to any lethal outcome (due to any cause), that would occur 30 days following surgery. | 30 days following surgery | |
Secondary | The incidence of local wound infections | Local wound infection will be defined as redness, pain and/or drainage on the surgical site, along with an increase in infectious parameters, with or without fever > 38°C. | 30 days following surgery | |
Secondary | The incidence of postoperative surgical complications | Postoperative surgical complications will be defined as complications related to the surgical procedure within 30 days after the operation. | 30 days following surgery | |
Secondary | The incidence of postoperative non-surgical complications | Postoperative non-surgical complications will be defined as complications which are not related to surgical procedures/techniques. | 30 days following surgery |
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