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NCT Number: NCT06607965

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

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Chongqing General Hospital

Chongqing, Chongqing Municipality, 400000, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. hemoglobin

    Time frame: 3 day

    Record the difference in indicators before and after surgery

  2. serum albumin

    Time frame: 3 day

    the difference in indicators before and after surgery.

  3. Postoperative Complication

    Time frame: 1 month

    Record the occurrence of related surgical complications in the experimental group and the control group.

  4. weight

    Time frame: 1week

    Record the difference in indicators before and after surgery

Sponsors and collaborators

Lead sponsor

Chongqing General Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Sep 23, 2024
Registry last updated
Dec 3, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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