NCT06805123 Early Feeding Versus Delayed Feeding After Colorectal Endoscopic Submucosal Dissection
| NCT ID | NCT06805123 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Pusan National University Hospital |
| Condition | Endoscopic Submucosal Dissection |
| Study Type | INTERVENTIONAL |
| Enrollment | 204 participants |
| Start Date | 2025-02-01 |
| Primary Completion | 2026-02-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 204 participants in total. It began in 2025-02-01 with a primary completion date of 2026-02-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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).
Eligibility 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
Contact & Investigator
Dong Hoon Baek, MD, PhD
PRINCIPAL INVESTIGATOR
Pusan National University Hospital
Frequently Asked Questions
Who can join the NCT06805123 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Endoscopic Submucosal Dissection. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06805123 currently recruiting?
Yes, NCT06805123 is actively recruiting participants. Contact the research team at lucky77i@naver.com for enrollment information.
Where is the NCT06805123 trial being conducted?
This trial is being conducted at Busan, South Korea, Busan, South Korea, Busan, South Korea, Ulsan, South Korea and 1 additional location.
Who is sponsoring the NCT06805123 clinical trial?
NCT06805123 is sponsored by Pusan National University Hospital. The principal investigator is Dong Hoon Baek, MD, PhD at Pusan National University Hospital. The trial plans to enroll 204 participants.