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

NCT06607965 | Completed

• 1 other identifier: KY S2023-039-01
• Study Type: interventional
• Target: 127
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Whey Protein; Thyroid Neoplasms; Neck Dislocation; Enhanced Recovery After Surgery

Outcome Measures

Primary Outcomes (4)

• 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

Study Arms (2)

experimental group

EXPERIMENTAL

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

control group

NO INTERVENTION

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

Interventions

Whey Protein and Carbohydrates DIETARY_SUPPLEMENT

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.

experimental group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Chongqing General Hospital: lead

Study Sites (1)

Chongqing General Hospital

Chongqing, Chongqing Municipality, 400000, China

Location

MeSH Terms

Conditions

Thyroid Neoplasms

Interventions

Whey Proteins; Carbohydrates

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Head and Neck Neoplasms; Endocrine System Diseases; Thyroid Diseases

Intervention Hierarchy (Ancestors)

Milk Proteins; Animal Proteins, Dietary; Dietary Proteins; Proteins; Amino Acids, Peptides, and Proteins; Whey; Milk; Dairy Products; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 13, 2024
• First Posted: September 23, 2024
• Study Start: March 1, 2023
• Primary Completion: March 31, 2024
• Study Completion: May 31, 2024
• Last Updated: December 3, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)