RecruitingNot ApplicableNCT06805123

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


Sponsor

Pusan National University Hospital

Enrollment

204 participants

Start Date

Feb 1, 2025

Study Type

INTERVENTIONAL

Conditions

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 post-ESD early complications (e.g., bleeding, perforation, post-coagulation syndrome), length of hospital stay, patient satisfaction, and delayed complications.


Eligibility

Min Age: 18 Years

Inclusion Criteria7

  • 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 Criteria7

  • 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

Interventions

OTHEREarly feeding

Begin drinking water 2 hours after the procedure. If no complications occur 2 hours after starting water intake, progress to a liquid diet. If no abnormalities are observed after the liquid diet, transition to a soft diet for the next meal.

OTHERLate feeding

Maintain fasting on the day of the procedure. Begin a liquid diet 24 hours after the procedure. If no complications occur after starting the liquid diet, transition to a soft diet at the next meal.


Locations(5)

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

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NCT06805123


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