NCT06805123Completed
Early Feeding Versus Delayed Feeding 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
Source: ClinicalTrials.gov · Last updated 23 Sept 2026
Brief summary (registry, in English)
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 early post-procedural adverse events (occurring within 24 hours after the procedure)(e.g., bleeding, perforation, post-coagulation syndrome), patient satisfaction, and delayed post-procedural adverse events (occurring more than 24 hours after the procedure).
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 204 (actual)
- First submitted
- 18 Jan 2025
- Start date
- 1 Feb 2025
- Primary completion date
- 1 Feb 2026
- Lead sponsor
- Pusan National University Hospital
- Diseases
- Colorectal cancer
- NCT number
- NCT06805123
What you commit to
- Study type: Interventional
- Participants enrolled: 204
- From 1 Feb 2025 to the primary completion date, 1 Feb 2026
- 5 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Criteria the registry did not label
- Eligible patients were adults (≥19 years) scheduled to undergo colorectal ESD who met one or more of the following indications:
- Differentiated early colorectal cancer ≤5 cm without ulceration and confined to the mucosa
- Laterally spreading tumor ≥2 cm
- Sessile polyp ≥2 cm
- Adenoma with fibrosis
- Differentiated early colorectal cancer without lymph node metastasis
- Colorectal subepithelial lesion These indications correspond to the reimbursement criteria for colorectal ESD under the Korean National Health Insurance system.
- The exclusion criteria were as follows:
- Untreated colorectal cancer
- Active inflammatory bowel disease
- Coagulopathy or prothrombin time-international normalized ratio \>1.5 despite medical correction, pregnancy
- Endoscopically unmanageable perforation or bleeding during the procedure
- Refusal to provide informed consent
Age in the registry: 19 years to - · Sex: All · Does not accept healthy volunteers
Sites (5)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Inje University Busan Paik Hospital Coordinator of this site? Confirm its status | Busan | South Korea | Unknown status |
| Kosin University Gospel Hospital Coordinator of this site? Confirm its status | Busan | South Korea | Unknown status |
| Pusan National University Hospital Coordinator of this site? Confirm its status | Busan | South Korea | Unknown status |
| Ulsan University Hospital Coordinator of this site? Confirm its status | Ulsan | South Korea | Unknown status |
| Pusan National University Yangsan Hospital Coordinator of this site? Confirm its status | Yangsan | South Korea | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.