Clinical trial NCT05778487: Carbohydrate Loading and Elderly Patients Undergoing Spine Surgery
Official title: The Effects of Preoperative Carbohydrate Loading on Elderly Patients Undergoing Orthopaedic Spine Surgery - A CSORN Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Diet, Carbohydrate Loading
Keywords: Carbohydrate Loading
Orthopaedics
Elderly
Spine
Cervical
Thoracolumbar
Fusion
Decompression
Discectomy
Gatorade
Lead sponsor: Horizon Health Network
Sponsor class: OTHER
First posted: 2023-03-21
Enrollment: 128
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The control group will include retrospectively recruited patients who did not receive preoperative carbohydrate loading, and the carbohydrate (CHO) group will include prospectively recruited patients, who will consume a carbohydrate drink prior to surgery.
Primary purpose: SUPPORTIVE_CARE

Brief summary: Carbohydrate loading, the consumption of carbohydrates prior to surgery, is an example of preoperative nutrition that has provided many benefits to surgical patients. Elderly patients (65 years of age and older) represent a large number of spine surgery recipients and due to the unique aspects of aging, proper preoperative nutrition is essential for this patient demographic. The goal of this research study is to determine if preoperative carbohydrate loading provides benefits to elderly patients through decreasing length of stay (LOS) in hospital and reducing perioperative patient adverse events, when undergoing orthopaedic spine surgeries. It is expected that preoperative carbohydrate loading in elderly patients receiving an orthopaedic spine surgery (fusion, decompression, or discectomy) will lead to greater outcomes through decreasing LOS in hospital and reducing perioperative patient adverse events compared to patients who did not receive preoperative carbohydrate loading.

Detailed description: Carbohydrate loading, the consumption of carbohydrates prior to surgery, is an example of preoperative nutrition that has provided many benefits to surgical patients. Because of this, preoperative carbohydrate loading has been included in the Enhanced Recovery After Surgery (ERAS) and Enhanced Recovery Canada (ERC) guidelines across a variety of surgical specialities; however, a gap in the literature remains within the field of orthopaedic surgery, specifically in cervical and thoracolumbar spine surgeries. Elderly patients (65 years of age and older) represent a large number of spine surgery recipients and due to the unique aspects of aging, proper preoperative nutrition is essential for this patient demographic. The goal of this research study is to determine if preoperative carbohydrate loading provides benefits to elderly patients through decreasing length of stay (LOS) in hospital and reducing perioperative patient adverse events, when undergoing orthopaedic spine surgeries. This is an ambispective research study including elderly patients from the Canadian Spine Outcomes and Research Network (CSORN) registry, who have either recently undergone, or are scheduled to undergo, an orthopaedic cervical or thoracolumbar spine surgery (fusion, decompression, or discectomy). The control group will include retrospectively recruited patients, and the carbohydrate (CHO) group will include prospectively recruited patients, who will consume a carbohydrate drink up to 2 hours prior to surgery. Groups will also be matched based on various patient demographic and surgical variables. LOS in hospital and perioperative patient adverse events are the outcome measurements of interest. Patient and surgical variables will also be collected for comparison. It is expected that preoperative carbohydrate loading in elderly patients receiving an orthopaedic spine surgery (fusion, decompression, or discectomy) will lead to greater outcomes through decreasing LOS in hospital and reducing perioperative patient adverse events compared to patients who did not receive preoperative carbohydrate loading.

Eligibility criteria: Inclusion Criteria:

* Patients must meet the age requirement,
* Have either recently undergone, or are scheduled to undergo an elective cervical or thoracolumbar spine surgery, including fusion, decompression, and discectomy procedures.

Exclusion Criteria:

* Potential participants will be excluded if they do not meet the age requirements,
* Have had, or will be having, cervical or thoracolumbar fusion, decompression or discectomy revision surgery,
* Are not able to consume the selected carbohydrate drink,
* Do not consent to participation in the research study,
* Or have diabetes.

Primary outcomes:
measure: Length of Stay (LOS) in Hospital
timeFrame: From the time the patient is admitted to hospital until they are released postoperatively, 0-Maximum hours required.
Secondary outcomes:
measure: Perioperative Patient Adverse Events
timeFrame: From the time the patient is admitted to hospital until they are released postoperatively, 0-Maximum hours required.
Other outcomes:
Locations:
city: Saint John
country: Canada
facility: Canada East Spine Centre at Saint John Regional Hospital
state: New Brunswick
Study officials:
affiliation: Canada East Spine Centre
name: Chris Small, MD
role: PRINCIPAL_INVESTIGATOR
References:
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citation: Singh SM, Liverpool A, Romeiser JL, Miller JD, Thacker J, Gan TJ, Bennett-Guerrero E. A U.S. survey of pre-operative carbohydrate-containing beverage use in colorectal enhanced recovery after surgery (ERAS) programs. Perioper Med (Lond). 2021 May 28;10(1):19. doi: 10.1186/s13741-021-00187-3.
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citation: Ackerman RS, Tufts CW, DePinto DG, Chen J, Altshuler JR, Serdiuk A, Cohen JB, Patel SY. How Sweet Is This? A Review and Evaluation of Preoperative Carbohydrate Loading in the Enhanced Recovery After Surgery Model. Nutr Clin Pract. 2020 Apr;35(2):246-253. doi: 10.1002/ncp.10427. Epub 2019 Oct 21.