What is this study trying to find out about colorectal endoscopic submucosal dissection?

This study is exploring the best timing to restart eating after colorectal ESD. It compares starting food within 24 hours versus waiting longer to see which approach leads to fewer early complications, shorter hospital stays, and better patient satisfaction. The research is sponsored by Pusan National University Hospital to improve care after this procedure.

Who may be eligible for this colorectal endoscopic submucosal dissection clinical trial?

Adults 18 years and older undergoing colorectal ESD for specific types of lesions may be eligible. Both males and females can participate. Important factors include no unresolved colorectal cancer, no active inflammatory bowel disease, and no bleeding disorders. Please review eligibility criteria for more details.

Is there any cost to participate in this colorectal endoscopic submucosal dissection clinical trial?

Study-related care, including the procedure and all trial visits, is provided at no cost. However, personal travel or other expenses may vary and are not guaranteed to be covered. Participants can plan accordingly for any non-study-related costs.

Actively Recruiting

Phase Not Applicable

Age: 18Years +

All Genders

ID06805123

Comparison of Clinical Outcomes According to Timing of Dietary Restart After Colorectal Endoscopic Submucosal Dissection A Prospective, Multicenter, Randomized Controlled Trial

Led by Pusan National University Hospital · Updated on 2026-05-05

204

Participants Needed

Research Sites

21 weeks

Total Duration

AI-Summary

What this Trial Is About

Researchers are investigating the best timing for restarting diet after colorectal endoscopic submucosal dissection ESD, a procedure for certain colorectal lesions. While early feeding after upper gastrointestinal ESD has shown benefits like shorter hospital stays and better patient satisfaction without increased complications, no studies have yet explored this in colorectal ESD. This study aims to compare early feeding within 24 hours versus delayed feeding after 24 hours in patients undergoing colorectal ESD, focusing on early complications, length of stay, and patient satisfaction. Participants are randomly assigned to either the early feeding group where water intake starts two hours after the procedure if no issues are found, progressing to liquid and then soft diets, or the delayed feeding group which remains fasting on the procedure day and begins a liquid diet 24 hours later followed by a soft diet. Both groups undergo standard colorectal ESD and follow-up examinations two hours post-procedure to check for abnormalities. Patient satisfaction surveys and outpatient clinic visits occur after discharge to monitor delayed complications and overall outcomes. Throughout the study, participants undergo various assessments including blood tests, ECG, and imaging before and after the procedure. Researchers collect detailed data on patient characteristics, lesion features, procedural details, complications, hospital stay length, and pathology results. The main outcome measured is the rate of early complications within 24 hours. Secondary outcomes include hospital stay duration and patient satisfaction. Statistical analysis will compare the two groups to determine if early feeding is not inferior to delayed feeding. The study will continue monitoring participants for about one year post-procedure.

CONDITIONS

Brief Title

Early Feeding Versus Delayed Feeding After Colorectal Endoscopic Submucosal Dissection

Who Can Participate

Age: 18Years +

All Genders

Eligibility Criteria

You may qualify if you...

Patients undergoing colorectal endoscopic submucosal dissection for differentiated early colorectal cancer confined to the mucosa without ulcers and measuring 5 cm or less
Patients with laterally spreading tumors measuring 2 cm or more
Patients with sessile polyps measuring 2 cm or more
Patients with adenomas accompanied by fibrosis
Patients with differentiated early colon or rectal cancer without lymph node metastasis, excluding those covered by partial self-payment insurance
Patients with submucosal tumors of the colon or rectum
Patients who have signed the consent form to participate in this study

You will not qualify if you...

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 prothrombin time (PT) INR of 1.5 or higher despite medical correction
Pregnant patients
Patients who refuse to participate in this study

Research Team

Seung Min Hong, MD

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