Carbohydrate Loading and Elderly Patients Undergoing Spine Surgery

NCT ID: NCT05778487

Last Updated: 2023-03-21

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 128 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-07-13
• Study Completion Date: 2025-01-31

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.

Conditions

Diet, Carbohydrate Loading

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Control Group

Standard of care for dietary instructions only.

The control group will consist of retrospectively recruited participants who have recently undergone a successful elective spine surgery, and followed the preoperative nutrition standards for their surgery, as outlined by the research institution's fasting dietary guidelines. Recruitment will include the most recent spine surgeries that meet the inclusion criteria and match prospective patient demographics.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Carbohydrate Group

Standard of care for dietary instructions + carbohydrate loading.

The carbohydrate (CHO) group will consist of prospectively recruited patients scheduled to undergo an elective spine surgery. These participants will also follow the preoperative nutrition standards, however, in addition, they will be instructed to consume 710ml of a simple, commercial carbohydrate sports drink on the day of their procedure up to 2 hours prior to surgery.

Group Type: EXPERIMENTAL

Gatorade Thirst Quencher

Intervention Type: DIETARY_SUPPLEMENT

Gatorade Thirst Quencher, 710ml (45g of carbohydrates, 6.3% carbohydrates, 25.4kcal/100ml)

Interventions

Gatorade Thirst Quencher

Gatorade Thirst Quencher, 710ml (45g of carbohydrates, 6.3% carbohydrates, 25.4kcal/100ml)

Intervention Type: DIETARY_SUPPLEMENT

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.

• Minimum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Horizon Health Network

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Chris Small, MD

Role: PRINCIPAL_INVESTIGATOR

Canada East Spine Centre

Locations

Canada East Spine Centre at Saint John Regional Hospital

Saint John, New Brunswick, Canada

Site Status: RECRUITING

Countries

Canada

Central Contacts

Canada East Spine Centre

Role: CONTACT

cescresearch@gmail.com

506-566-1451

Kevan Kostynski

Role: CONTACT

kevan.kostynski@dal.ca

Facility Contacts

Canada East Spine Centre

Role: primary

cescresearch@gmail.com

506-566-1451

Kevan Kostynski

Role: backup

kevan.kostynski@dal.ca

References

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Reference Type: BACKGROUND

PMID: 21781358 (View on PubMed)

Yang R, Wolfson M, Lewis MC. Unique Aspects of the Elderly Surgical Population: An Anesthesiologist's Perspective. Geriatr Orthop Surg Rehabil. 2011 Mar;2(2):56-64. doi: 10.1177/2151458510394606.

Reference Type: BACKGROUND

PMID: 23569671 (View on PubMed)

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Reference Type: BACKGROUND

PMID: 31036609 (View on PubMed)

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Reference Type: BACKGROUND

PMID: 22450530 (View on PubMed)

Wainwright TW et al. Consensus statement for perioperative care in total hip replacement and total knee replacement surgery: Enhanced Recovery After Surgery (ERAS(R)) Society recommendations. Acta Orthop. 2020 Jun;91(3):363. doi: 10.1080/17453674.2020.1724674. Epub 2020 Feb 14. No abstract available.

Reference Type: BACKGROUND

PMID: 32056486 (View on PubMed)

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Reference Type: BACKGROUND

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Reference Type: BACKGROUND

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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.

Reference Type: BACKGROUND

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Reference Type: BACKGROUND

PMID: 28097305 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 31637778 (View on PubMed)

Other Identifiers

HorizonHN

Identifier Type: -

Identifier Source: org_study_id