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

Plain Language Summary

Simplified for easier understanding

This study is comparing whether patients can eat sooner (early feeding) or need to wait longer (delayed feeding) after a type of advanced colonoscopy procedure called endoscopic submucosal dissection (ESD), where polyps or early cancers are carefully removed from the colon or rectum. **You may be eligible if...** - You are 18 or older - You are scheduled for ESD to remove a colorectal polyp or early cancer meeting specific criteria (such as large flat polyps or early confined cancers) - You have signed consent to participate **You may NOT be eligible if...** - You have active colorectal cancer that has not been treated - You have active inflammatory bowel disease (Crohn's or ulcerative colitis) - You have blood clotting disorders or abnormal clotting test results that cannot be corrected - You are pregnant Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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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