Whey Protein and Carbohydrates in ERAS for Recovery After Thyroidectomy: A Cohort Study

Effects of Whey Protein Combined With Carbohydrates in the ERAS Protocol on the Recovery of Thyroid Cancer Patients After Lateral Neck Dissection: A Prospective Cohort Study

Exploring the effects of whey protein combined with carbohydrates in an Enhanced Recovery After Surgery (ERAS) protocol on the postoperative recovery of thyroid cancer patients undergoing lateral neck dissection, aiming to provide more precise research and guidance for the perioperative accelerated recovery plan in such patients. The goal is to accelerate postoperative recovery and reduce postoperative complications for thyroid cancer patients undergoing neck dissection.

Study Overview

• Status: Completed
• Conditions: Thyroid Neoplasms; Enhanced Recovery After Surgery; Neck Dislocation; Whey Protein
• Intervention / Treatment: Dietary supplement: Whey Protein and Carbohydrates

Detailed Description

Perioperative dietary management was differentiated between the two groups:

Experimental Group:

6 hours before surgery, patients orally consumed 250 ml of a full-nutrition liquid (220 ml homogenized diet, 50 g; containing 31.4 g carbohydrates, 8 g protein, and 215 kcal).

2 hours before surgery, patients orally consumed 200 ml of a clear liquid (50 g enzymatically hydrolyzed rice powder + 0.5 g low-sodium salt; containing 47.7 g carbohydrates, 6.5 g whey protein, and 193 kcal).

After surgery, once there were no symptoms such as dizziness or vomiting, patients could start consuming clear liquids (containing 47.7 g carbohydrates, 6.5 g protein, and 221 kcal) orally every 30 minutes, 4 times on the day of surgery.

Starting from the first day after surgery, patients consumed 200 ml of fat-free nutritional liquid (50 g enzymatically hydrolyzed rice powder + 7.5 g isolated whey protein + 0.5 g low-sodium salt; 223 kcal) per serving, 4 to 6 times per day as needed.

Control Group:

Patients fasted for 12 hours before surgery, and after surgery, intravenous fluids were administered. Fat-free diet began after 24 hours post-surgery.

Discharge Criteria: The discharge time was determined by the surgeon based on the patient's postoperative drainage condition and the presence or absence of complications.

• Study Type: Interventional
• Enrollment (Actual): 127
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Chongqing
    • Chongqing, Chongqing, China, 400000
      • Chongqing General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Aged 18 years or older;
• Differentiated thyroid cancer with lateral lymph node dissection;
• Written informed consent provided by the participant.

Exclusion Criteria:

• History of chronic liver or kidney disease, ischemic heart disease, or diabetes;
• Previous neck surgery or history of iodine-131 radiation;
• Allergy to soy or whey protein;
• Intraoperative chylous leak;
• Other special types of thyroid cancer.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: experimental group; Experimental Group: 6 hours before surgery, patients orally consumed 250 ml of a full-nutrition liquid (220 ml homogenized diet, 50 g; containing 31.4 g carbohydrates, 8 g protein, and 215 kcal). 2 hours before surgery, patients orally consumed 200 ml of a clear liquid (50 g enzymatically hydrolyzed rice powder + 0.5 g low-sodium salt; containing 47.7 g carbohydrates, 6.5 g whey protein, and 193 kcal). After surgery, once there were no symptoms such as dizziness or vomiting, patients could start consuming clear liquids (containing 47.7 g carbohydrates, 6.5 g protein, and 221 kcal) orally every 30 minutes, 4 times on the day of surgery. Starting from the first day after surgery, patients consumed 200 ml of fat-free nutritional liquid (50 g enzymatically hydrolyzed rice powder + 7.5 g isolated whey protein + 0.5 g low-sodium salt; 223 kcal) per serving, 4 to 6 times per day as needed.	Dietary supplement: Whey Protein and Carbohydrates; Experimental Group: 6 hours before surgery, patients orally consumed 250 ml of a full-nutrition liquid (220 ml homogenized diet, 50 g; containing 31.4 g carbohydrates, 8 g protein, and 215 kcal). 2 hours before surgery, patients orally consumed 200 ml of a clear liquid (50 g enzymatically hydrolyzed rice powder + 0.5 g low-sodium salt; containing 47.7 g carbohydrates, 6.5 g whey protein, and 193 kcal). After surgery, once there were no symptoms such as dizziness or vomiting, patients could start consuming clear liquids (containing 47.7 g carbohydrates, 6.5 g protein, and 221 kcal) orally every 30 minutes, 4 times on the day of surgery. Starting from the first day after surgery, patients consumed 200 ml of fat-free nutritional liquid (50 g enzymatically hydrolyzed rice powder + 7.5 g isolated whey protein + 0.5 g low-sodium salt; 223 kcal) per serving, 4 to 6 times per day as needed.
No Intervention: control group; Patients fasted for 12 hours before surgery, and after surgery, intravenous fluids were administered. Fat-free diet began after 24 hours post-surgery.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
hemoglobin	Record the difference in indicators before and after surgery	3 day
serum albumin	the difference in indicators before and after surgery.	3 day
Postoperative Complication	Record the occurrence of related surgical complications in the experimental group and the control group.	1 month
weight	Record the difference in indicators before and after surgery	1week

Collaborators and Investigators

• Sponsor: Chongqing General Hospital

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2023
• Primary Completion (Actual): March 31, 2024
• Study Completion (Actual): May 31, 2024

Study Registration Dates

• First Submitted: September 13, 2024
• First Submitted That Met QC Criteria: September 19, 2024
• First Posted (Actual): September 23, 2024

Study Record Updates

• Last Update Posted (Actual): December 3, 2024
• Last Update Submitted That Met QC Criteria: December 2, 2024
• Last Verified: September 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Endocrine System Diseases; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Head and Neck Neoplasms; Thyroid Diseases; Thyroid Neoplasms
• Other Study ID Numbers: KY S2023-039-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No