- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07349576
Precision Dietary Intervention Improves Postoperative Energy Intake, Nutritional Status, and Recovery in Patients Undergoing Hepatectomy for Liver Cancer: A Randomized Controlled Trial
Objective:To explore the application effect of postoperative refined early dietary plan in the enhanced recovery of patients undergoing hepatectomy for primary liver cancer, and to provide scientific evidence for optimizing postoperative dietary structure and increasing oral energy intake of patients.
Methods:In this randomized, parallel-controlled trial, 142 colorectal cancer survivors meeting inclusion criteria were recruited from a tertiary hospital in Hefei, Anhui Province. Participants were randomly assigned in a 1:1 ratio to either the dietary intervention group or the conventional diet group. Both the standard care group and the dietary intervention group received 5 days of routine dietary care. The dietary intervention group additionally received specialized meal plans and whole protein supplements beyond the standard care regimen. Dietary intake, nutritional status, and postoperative recovery outcomes were measured and compared between the two groups.
Study Overview
Status
Conditions
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
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Anhui
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Hefei, Anhui, China, 230000
- Anhui Provincal Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- (1) Pathologically confirmed diagnosis of primary hepatocellular carcinoma; (2) Underwent elective (partial) hepatectomy; (3) Age 18-80 years; (4) Basically normal renal function and preoperative Child-Pugh liver function grade A or B; (5) Voluntary participation in the study and signed informed consent.
Exclusion Criteria:
- (1) Concurrent malignant tumors; (2) Postoperative deterioration or contraindications to oral intake (e.g., dysphagia, intestinal obstruction); (3) Severe malnutrition or other disorders affecting nutritional metabolism; (4) Major intraoperative complications (e.g., massive hemorrhage, bile leakage, intra-abdominal adhesions); (5) Postoperative transfer to the ICU.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Experimental: dietary intervention group
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The intervention group, based on the control group, followed the "Chinese Clinical Practice Guidelines for Enhanced Recovery After Surgery (Part II)"and evidence-based summaries, combined with the "Chinese Expert Consensus on Perioperative Management for Hepatectomy in Hepatocellular Carcinoma (2021 Edition)" and oral nutritional supplementation guidelines, Based on the patient's comorbidities, liver characteristics, and gastrointestinal recovery patterns, a specialized 5-day post-hepatectomy diet plan for liver cancer patients has been developed.
Postoperatively, oral nutritional supplements (ONS) were administered at 9:30 AM and 3:00 PM between meals, and at 9:00 PM after dinner, using the whole protein preparation NUTRICIA(specification: 320g/can, manufacturer: Milupa GmbH, Germany, production batch: HJ20170172).
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Experimental: standard care group
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After returning to the ward after the operation under the traditional dietary guidance model, the patient regained consciousness under anesthesia without nausea, vomiting, etc., and began to try drinking water.
If there are no special conditions such as gastrointestinal discomfort, then starting according to the dietary principles, that is, a liquid diet on the first day after the operation, a semi-liquid diet on the second day, and gradually transitioning to a regular diet from the third day after the operation until discharge based on the patient's tolerance.
One to two days after the operation, parenteral nutrition mixtures are routinely infused.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
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Prealbumin
Time Frame: Six days after the operation
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Six days after the operation
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albumin
Time Frame: Six days after the operation
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Six days after the operation
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2024KY-013
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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