Early Feeding Versus Delayed Feeding After Colorectal Endoscopic Submucosal Dissection

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorPusan National University Hospital

About this trial

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

Qualifiers

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

Disqualifiers

Under 18 years of age

Patients with unresolved colorectal cancer

Patients with non-remissive inflammatory bowel disease (IBD)

Patients with blood coagulation disorders

Trial design

Treatments tested in this trial

  • Early feeding
  • Late feeding

Treatment groups

204 Participants
are divided into 2 treatment groups

Locations

5
Inje university busan paik hospital47392, Busan South Korea
Kosin university gospel hospital49267, Busan South Korea
Pusan National University Hospital49241, Busan South Korea
Ulsan university hospital44033, Ulsan South Korea

Sponsors and collaborators

Pusan National University Hospital

Lead sponsor