Comparing Early and Late Diet Restart After Colorectal Endoscopic Submucosal Dissection to Improve Recovery and Safety
Led by Pusan National University Hospital · Updated on 2026-06-17
204
Participants Needed
5
Research Sites
47 weeks
Total Duration
AI-Summary
What this Trial Is About
Researchers are investigating the best timing to restart eating after colorectal endoscopic submucosal dissection ESD, a procedure used to treat certain colorectal lesions. While previous studies on upper gastrointestinal ESD showed that early feeding within one day of the procedure did not increase complications and improved patient satisfaction, no studies have yet examined early feeding after colorectal ESD. This study aims to compare early feeding started within 24 hours after colorectal ESD to delayed feeding started after 24 hours, focusing on adverse events and patient satisfaction.
Participants are randomly assigned to one of two groups. In the early feeding group, patients begin drinking water two hours after the procedure if no abnormalities are found during follow-up exams, then progress to a liquid diet and soft diet if no complications arise. In the delayed feeding group, patients fast on the day of the procedure and start a liquid diet 24 hours later, followed by a soft diet if tolerated. Both groups undergo standard colorectal ESD and monitoring such as physical exams, blood tests, and X-rays.
Throughout the study, participants provide information on medical history, lesion details, procedure outcomes, and complications. Researchers assess early adverse events within 24 hours and delayed events beyond 24 hours, along with patient satisfaction using surveys. Follow-up visits after discharge help review outcomes and complications. The study collects detailed clinical and laboratory data and uses statistical methods to compare safety and satisfaction between the two dietary timing approaches.
CONDITIONS
Brief Title
Early Feeding Versus Delayed Feeding After Colorectal Endoscopic Submucosal Dissection
Research Team
S
Seung Min Hong, MD
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Patients undergoing colorectal endoscopic submucosal dissection for differentiated early colorectal cancer confined to the mucosa without ulcers and measuring 4 cm
Patients with laterally spreading tumors measuring 2 cm
Patients with sessile polyps measuring 2 cm
Patients with adenomas accompanied by fibrosis
Patients with differentiated early cancer of the colon or rectum 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 the study
You will not qualify if you...
Patients 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 6 1.5 despite medical correction
Pregnant patients
Patients who refuse to participate in the study
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Procedure and Initial Monitoring
Duration - 1 day
Participants undergo standard colorectal endoscopic submucosal dissection followed by examinations including physical checks, blood tests, and X-rays two hours after the procedure.
1 visit (in-person)
Dietary Intervention
Duration - Until discharge
Participants follow either early feeding starting with water intake two hours after the procedure progressing to liquid and soft diets, or delayed feeding with fasting on the procedure day and starting a liquid diet 24 hours later.
Daily monitoring during hospital stay
Follow-up
Duration - Up to 1 year
Participants visit the outpatient clinic after discharge to review procedural outcomes, assess for delayed complications, and complete satisfaction surveys.
Periodic outpatient visits
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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Published Research Related To This Trial
The effect of early oral postoperative feeding on the recovery of intestinal motility after gastrointestinal surgery: a systematic review and meta-analysis of randomized clinical trials.