Early Feeding Versus Delayed Feeding After Colorectal Endoscopic Submucosal Dissection

April 29, 2026 updated by: Seung Min Hong, Pusan National University Hospital

Comparison of Clinical Outcomes According to Timing of Dietary Restart After Colorectal Endoscopic Submucosal Dissection: A Prospective, Multicenter, Randomized Controlled Trial

Currently, there are no clear guidelines regarding the optimal timing for dietary restart after gastrointestinal endoscopic submucosal dissection (ESD). While several studies have addressed upper gastrointestinal ESD, a meta-analysis reported that early feeding, initiated within one day after the procedure, showed no statistically significant difference in complication rates compared to delayed feeding initiated after two or more days. Moreover, early feeding was associated with shorter hospital stays and higher patient satisfaction. However, to the best of our knowledge, no studies have investigated early feeding in colorectal ESD.

On the other hand, in the context of surgical procedures involving the gastrointestinal tract, several studies suggest that early feeding may offer clinical advantages over delayed feeding.

The aim of this study is to explore the optimal timing for dietary restart following colorectal ESD. In the early feeding group (<24 hours), patients begin water intake if no abnormalities are observed during a follow-up examination conducted two hours post-procedure. If no further issues arise after an additional two hours, a liquid diet is initiated. In contrast, the delayed feeding group (>24 hours) maintains fasting on the day of the procedure and begins a liquid diet the following day. The study will compare the early and delayed feeding groups in terms of post-ESD early complications (e.g., bleeding, perforation, post-coagulation syndrome), length of hospital stay, patient satisfaction, and delayed complications.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

# Sample Size Calculation: This clinical study aims to demonstrate that the experimental group (early feeding group, P1) is not clinically inferior to the control group (delayed feeding group, P2) in patients undergoing colorectal endoscopic submucosal dissection (ESD). The primary efficacy endpoint is set as the incidence rate of early complications within 24 hours post-procedure. For non-inferiority testing, the incidence of early complications (P1 = P2) was assumed to be 3%. The non-inferiority margin (D) was set at 8%, with a significance level (alpha) of 2.5%, power of 80%, and a 1:1 allocation ratio. Using the PASS software (version 11), the calculated sample size was 74 patients per group. Considering a dropout rate of 5%, the required sample size is 78 patients per group, totaling 156 participants.

# Randomization and Blinding: This clinical study employs block randomization to allocate participants to the experimental group (early feeding) and the control group (delayed feeding) in a 1:1 ratio. Blinding will not be applied. A randomization table will be generated independently by a statistician from the Medical Statistics Department of Pusan National University Hospital, using the blockrand package in R (version 4.3.3; R Core Team, 2024, http://cran.r-project.org). The block size will remain blinded.

# Research Participation Procedure: After signing the consent form, the admission process is initiated. Basic tests such as blood tests, ECG, and chest/abdominal X-rays are conducted. Fasting and bowel preparation are performed the day before the procedure.

# Procedure and Initial Management: On the day of the procedure, both groups undergo standard colorectal ESD. Two hours after the procedure, a physical examination, CBC, and chest/abdominal X-rays are performed.

# Dietary Group Classification: Early Feeding Group: If no abnormalities are found during the examination 2 hours after the procedure, water intake begins, followed by a liquid diet and then a porridge diet if no complications occur.

Late Feeding Group: Patients remain fasting on the day of the procedure. A liquid diet begins 24 hours after the procedure, followed by a porridge diet if no complications occur.

# Survey: Patient satisfaction is evaluated through a survey. Patients visit the outpatient clinic after discharge to review procedural outcomes and assess for delayed complications.

# Observation Items: Age, sex, height, weight, BMI, underlying diseases (hypertension, diabetes, cerebrovascular disease, ischemic heart disease, other heart diseases, atrial fibrillation (or atrial flutter), other arrhythmias, chronic kidney disease, dialysis status, liver cirrhosis, other vascular diseases), history of previous abdominal surgery, smoking history, alcohol consumption history, medication history (aspirin, clopidogrel, other antithrombotic agents, warfarin, direct oral anticoagulants (DOACs), nonsteroidal anti-inflammatory drugs (NSAIDs), steroids), type of bowel preparation used, pre-procedure serum white blood cell count, pre-procedure serum hemoglobin, pre-procedure serum platelet count, pre-procedure absolute neutrophil count, pre-procedure prothrombin time (PT) (including INR), pre-procedure activated partial thromboplastin time (aPTT), post-procedure serum white blood cell count, post-procedure serum hemoglobin, post-procedure serum platelet count, post-procedure absolute neutrophil count, location of the lesion, size of the lesion (long axis, short axis), macroscopic morphology of the lesion, degree of submucosal fibrosis, resection method, resection time, post-resection management time, total procedure time, type of post-resection management performed, en bloc resection status, occurrence of complications during the procedure, measures taken for intra-procedural complications and their outcomes, occurrence of complications within 24 hours post-procedure, measures taken for complications within 24 hours post-procedure and their outcomes, occurrence of complications beyond 24 hours post-procedure, measures taken for complications beyond 24 hours post-procedure and their outcomes, length of hospital stay (days), pathology results (histology, differentiation grade, invasion depth, horizontal resection margin, vertical resection margin, lymphatic invasion, vascular invasion, perineural invasion), number of days until outpatient follow-up after discharge, patient satisfaction (Likert scale).

# Data Analysis and Statistical Methods: Descriptive statistics will be used to summarize the data: continuous variables will be presented as the number of observations, mean, standard deviation, minimum, maximum, and quartiles, while categorical variables will be presented as frequencies and percentages. Group comparisons will be conducted using an independent t-test or Wilcoxon rank-sum test for continuous variables and a chi-square test or Fisher's exact test for categorical variables. To confirm the non-inferiority of the treatment group (T) compared to the control group (C), the two-sided 95% confidence interval for the difference in proportions (T-C) will be calculated. Non-inferiority will be established if the upper limit of the confidence interval is within the predefined non-inferiority margin. A two-sided test will be performed at a significance level of 5%. No interim analysis will be conducted in this clinical study, and no imputation methods for missing data will be applied.

Study Type

Interventional

Enrollment (Estimated)

204

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • South Korea
      • Busan, South Korea, 49241
        • Recruiting
        • Pusan National University Hospital
        • Contact:
      • Busan, South Korea, 47392
        • Recruiting
        • Inje University Busan Paik Hospital
        • Contact:
      • Busan, South Korea, 49267
        • Recruiting
        • Kosin University Gospel Hospital
        • Contact:
      • Ulsan, South Korea, 44033
        • Recruiting
        • Ulsan University Hospital
        • Contact:
      • Yangsan, South Korea, 50612
        • Recruiting
        • Pusan National University Yangsan Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria: Patients undergoing colorectal endoscopic submucosal dissection for the following lesions:

  • Differentiated early colorectal cancer confined to the mucosa, without ulcers, and measuring ≤5 cm
  • Laterally spreading tumors measuring ≥2 cm
  • Sessile polyps measuring ≥2 cm
  • Adenomas accompanied by fibrosis
  • Differentiated early cancer of the colon or rectum without lymph node metastasis, aside from those covered by partial self-payment insurance (Korean National Health insurance)
  • Submucosal tumors of the colon or rectum
  • Patients who have signed the consent form to participate in this study

Exclusion Criteria:

  • Under 18 years of age
  • Patients with unresolved colorectal cancer
  • Patients with non-remissive inflammatory bowel disease (IBD)
  • Patients with blood coagulation disorders
  • Patients with a prothrombin time (PT) INR ≥ 1.5 despite medical correction
  • Pregnant patients
  • Patients who refuse to participate in this study

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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
Experimental: Early feeding group
The group implementing early feeding (< 24hr).
Other: Early feeding
Begin drinking water 2 hours after the procedure. If no complications occur 2 hours after starting water intake, progress to a liquid diet. If no abnormalities are observed after the liquid diet, transition to a soft diet for the next meal.
Active Comparator: Late feeding group
The group implementing late feeding (> 24hr).
Other: Late feeding
Maintain fasting on the day of the procedure. Begin a liquid diet 24 hours after the procedure. If no complications occur after starting the liquid diet, transition to a soft diet at the next meal.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Complication
Time Frame: Through study completion, an average of 1 year
Bleeding, perforation, Post procedural coagulation syndrome
Through study completion, an average of 1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Length of hospital stay
Time Frame: through study completion, an average of 1 year
The number of days from admission to discharge
through study completion, an average of 1 year
patient satisfaction
Time Frame: through study completion, an average of 1 year
Patient satisfaction is assessed through a survey conducted with the patients.
through study completion, an average of 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pusan National University Hospital

Investigators

  • Principal Investigator: Dong Hoon Baek, MD, PhD, Pusan National University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2025

Primary Completion (Actual)

February 1, 2026

Study Completion (Estimated)

June 30, 2026

Study Registration Dates

First Submitted

January 18, 2025

First Submitted That Met QC Criteria

January 27, 2025

First Posted (Actual)

February 3, 2025

Study Record Updates

Last Update Posted (Actual)

May 5, 2026

Last Update Submitted That Met QC Criteria

April 29, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2411-009-145

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

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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