Early Feeding Versus Delayed Feeding After Colorectal Endoscopic Submucosal Dissection
Recruiting · NCT06805123 · Interventional (participants receive a specific treatment) · Lead sponsor: Pusan National University Hospital
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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).
Who can take part
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 it is running
5 locations listed.
- Inje university busan paik hospital - Busan, South Korea
- Pusan National University Hospital - Busan, South Korea
- Kosin university gospel hospital - Busan, South Korea
- Ulsan university hospital - Ulsan, South Korea
- Pusan National University Yangsan Hospital - Yangsan, South Korea