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

Status: Recruiting
Location: See all (5) locations...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Republic of Korea
Inje university busan paik hospital
RECRUITING
Busan
Kosin university gospel hospital
RECRUITING
Busan
Pusan National University Hospital
RECRUITING
Busan
Ulsan university hospital
RECRUITING
Ulsan
Pusan National University Yangsan Hospital
RECRUITING
Yangsan
Contact Information
Primary
Seung Min Hong, MD
lucky77i@naver.com
+82-10-2330-8181
Time Frame
Start Date: 2025-02-01
Estimated Completion Date: 2026-06-30
Participants
Target number of participants: 204
Treatments
Experimental: Early feeding group
The group implementing early feeding (\< 24hr).
Active_comparator: Late feeding group
The group implementing late feeding (\> 24hr).
Related Therapeutic Areas
Sponsors
Leads: Pusan National University Hospital

This content was sourced from clinicaltrials.gov