Carbohydrate Loading and Elderly Patients Undergoing Spine Surgery

Sponsor
Horizon Health Network (Other)
Overall Status
Recruiting
CT.gov ID
NCT05778487
Collaborator
(none)
128
1
2
29.7
4.3

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Dietary Supplement: Gatorade Thirst Quencher
N/A

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
128 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
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.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.
Masking:
None (Open Label)
Primary Purpose:
Supportive Care
Official Title:
The Effects of Preoperative Carbohydrate Loading on Elderly Patients Undergoing Orthopaedic Spine Surgery - A CSORN Study
Actual Study Start Date :
Jul 13, 2022
Anticipated Primary Completion Date :
Jul 1, 2024
Anticipated Study Completion Date :
Jan 1, 2025

Arms and Interventions

Arm Intervention/Treatment
No Intervention: 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.

Experimental: 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.

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

Outcome Measures

Primary Outcome Measures

  1. Length of Stay (LOS) in Hospital [From the time the patient is admitted to hospital until they are released postoperatively, 0-Maximum hours required.]

    How long (hours) are the patients staying in hospital for?

Secondary Outcome Measures

  1. Perioperative Patient Adverse Events [From the time the patient is admitted to hospital until they are released postoperatively, 0-Maximum hours required.]

    Do the patients experience any adverse events in hospital such as pain, nausea, vomiting?

Eligibility Criteria

Criteria

Ages Eligible for Study:
65 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Canada East Spine Centre at Saint John Regional Hospital Saint John New Brunswick Canada E2L 4L2

Sponsors and Collaborators

  • Horizon Health Network

Investigators

  • Principal Investigator: Chris Small, MD, Canada East Spine Centre

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Horizon Health Network
ClinicalTrials.gov Identifier:
NCT05778487
Other Study ID Numbers:
  • HorizonHN
First Posted:
Mar 21, 2023
Last Update Posted:
Mar 21, 2023
Last Verified:
Mar 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Horizon Health Network

Study Results

No Results Posted as of Mar 21, 2023