Colorectal polypectomy and endoscopic mucosal resection (EMR): European Society of Gastrointestinal Endoscopy (ESGE) Clinical Guideline.
Monika Ferlitsch, Alan Moss, Cesare Hassan...
https://pubmed.ncbi.nlm.nih.gov/28212588Actively Recruiting
Phase Not Applicable
Age: 18Years +
All Genders
ID06805123
Comparison of Clinical Outcomes According to Timing of Dietary Restart After Colorectal Endoscopic Submucosal Dissection A Prospective, Multicenter, Randomized Controlled Trial
Led by Pusan National University Hospital · Updated on 2026-05-05
204
Participants Needed
5
Research Sites
21 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are investigating the best timing for restarting diet after colorectal endoscopic submucosal dissection (ESD), a procedure for certain colorectal lesions. While early feeding after upper gastrointestinal ESD has shown benefits like shorter hospital stays and better patient satisfaction without increased complications, no studies have yet explored this in colorectal ESD. This study aims to compare early feeding within 24 hours versus delayed feeding after 24 hours in patients undergoing colorectal ESD, focusing on early complications, length of stay, and patient satisfaction. Participants are randomly assigned to either the early feeding group where water intake starts two hours after the procedure if no issues are found, progressing to liquid and then soft diets, or the delayed feeding group which remains fasting on the procedure day and begins a liquid diet 24 hours later followed by a soft diet. Both groups undergo standard colorectal ESD and follow-up examinations two hours post-procedure to check for abnormalities. Patient satisfaction surveys and outpatient clinic visits occur after discharge to monitor delayed complications and overall outcomes. Throughout the study, participants undergo various assessments including blood tests, ECG, and imaging before and after the procedure. Researchers collect detailed data on patient characteristics, lesion features, procedural details, complications, hospital stay length, and pathology results. The main outcome measured is the rate of early complications within 24 hours. Secondary outcomes include hospital stay duration and patient satisfaction. Statistical analysis will compare the two groups to determine if early feeding is not inferior to delayed feeding. The study will continue monitoring participants for about one year post-procedure.
CONDITIONS
Brief Title
Early Feeding Versus Delayed Feeding After Colorectal Endoscopic Submucosal Dissection
Who Can Participate
Age: 18Years +
All Genders
Eligibility Criteria
You may qualify if you...
- Patients undergoing colorectal endoscopic submucosal dissection for differentiated early colorectal cancer confined to the mucosa without ulcers and measuring 5 cm or less
- Patients with laterally spreading tumors measuring 2 cm or more
- Patients with sessile polyps measuring 2 cm or more
- Patients with adenomas accompanied by fibrosis
- Patients with differentiated early colon or rectal cancer without lymph node metastasis, excluding those covered by partial self-payment insurance
- Patients with submucosal tumors of the colon or rectum
- Patients who have signed the consent form to participate in this study
You will not qualify if you...
- 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 prothrombin time (PT) INR of 1.5 or higher despite medical correction
- Pregnant patients
- Patients who refuse to participate in this study
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Procedure and Initial Management
Duration - 1 day
Participants undergo colorectal endoscopic submucosal dissection (ESD) followed by examinations 2 hours after the procedure to check for complications.
1 visit (in-person)
Dietary Intervention
Duration - Up to 2 days
Participants are assigned to either early feeding starting 2 hours after the procedure or delayed feeding starting 24 hours after the procedure, progressing through water, liquid, and soft diets as tolerated without complications.
During hospital stay
Post-discharge Follow-up
Duration - Approximately 1 year
Participants visit the outpatient clinic after discharge to review procedural outcomes, assess for delayed complications, and complete a patient satisfaction survey.
1 or more outpatient visits
Trial Site Locations
Total: 5 locations
1
Inje university busan paik hospital
Busan, South Korea, 47392
Actively Recruiting
2
Pusan National University Hospital
Busan, South Korea, 49241
Actively Recruiting
3
Kosin university gospel hospital
Busan, South Korea, 49267
Actively Recruiting
4
Ulsan university hospital
Ulsan, South Korea, 44033
Actively Recruiting
5
Pusan National University Yangsan Hospital
Yangsan, South Korea, 50612
Actively Recruiting
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Research Team
S
Seung Min Hong, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
SUPPORTIVE_CARE
Number of Arms
2
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https://pubmed.ncbi.nlm.nih.gov/38818132