Early versus delayed eating after colorectal endoscopic submucosal dissection
Comparison of Clinical Outcomes According to Timing of Dietary Restart After Colorectal Endoscopic Submucosal Dissection: A Prospective, Multicenter, Randomized Controlled Trial
This test checks whether starting water and light food within 24 hours after colorectal ESD is as safe for adults as waiting two or more days.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 204 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Pusan National University Hospital Academic / other |
| Locations | 5 sites (Busan and 4 other locations) |
| Trial ID | NCT06805123 on ClinicalTrials.gov |
What this trial studies
Adults undergoing colorectal endoscopic submucosal dissection are randomly assigned in a 1:1, open-label, non-inferiority trial to either early feeding (<24 hours) or delayed feeding (≥48 hours). The primary endpoint is the rate of early complications within 24 hours after the procedure, with a non-inferiority margin of 8% and a planned total enrollment of 156 patients. Block randomization is used and the study is conducted at multiple tertiary hospitals in Busan, South Korea. No blinding is applied and secondary outcomes include hospital length of stay and patient-reported satisfaction.
Who should consider this trial
Good fit: Adults scheduled for colorectal ESD for lesions such as large adenomas, laterally spreading tumors, differentiated early colorectal cancer without nodal spread, or submucosal tumors who can give informed consent are ideal candidates.
Not a fit: Patients under 18, those with unresolved colorectal cancer, active inflammatory bowel disease, significant coagulation problems (e.g., PT INR ≥ 1.5), pregnant patients, or those who decline participation are unlikely to benefit from joining this protocol.
Why it matters
Potential benefit: If successful, early feeding could allow patients to leave the hospital sooner and feel better after colorectal ESD without increasing short-term complications.
How similar studies have performed: Previous studies and a meta-analysis in upper gastrointestinal ESD and surgical GI procedures found early feeding produced similar complication rates with shorter stays and higher satisfaction, but early feeding has not been previously studied specifically after colorectal ESD.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Busan and 4 other locations
- Inje university busan paik hospital — Busan, South Korea (Recruiting)
- Pusan National University Hospital — Busan, South Korea (Recruiting)
- Kosin university gospel hospital — Busan, South Korea (Recruiting)
- Ulsan university hospital — Ulsan, South Korea (Recruiting)
- Pusan National University Yangsan Hospital — Yangsan, South Korea (Recruiting)
Study contacts
- Principal investigator: Dong Hoon Baek, MD, PhD — Pusan National University Hospital
- Study coordinator: Seung Min Hong, MD
- Email: lucky77i@naver.com
- Phone: +82-10-2330-8181
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.