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Trial Title:
Whey Protein and Carbohydrates in ERAS for Recovery After Thyroidectomy: A Cohort Study
NCT ID:
NCT06607965
Condition:
Whey Protein
Thyroid Neoplasms
Neck Dislocation
Enhanced Recovery After Surgery
Conditions: Official terms:
Thyroid Neoplasms
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Supportive Care
Masking:
Double (Participant, Investigator)
Intervention:
Intervention type:
Dietary Supplement
Intervention name:
Whey Protein and Carbohydrates
Description:
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.
Arm group label:
experimental group
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.
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.
Criteria for eligibility:
Criteria:
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.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Chongqing General Hospital
Address:
City:
Chongqing
Zip:
400000
Country:
China
Status:
Recruiting
Contact:
Last name:
Cunye Yan, master
Phone:
+8615856381227
Email:
yancunye@outlook.com
Start date:
September 1, 2023
Completion date:
November 1, 2024
Lead sponsor:
Agency:
Chongqing General Hospital
Agency class:
Other
Source:
Chongqing General Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06607965