Clinical trial · Interventional
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 26, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260926-000001
Summary
Brief summary (as posted)
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).
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Colorectal Neoplasms | Colorectal Neoplasm | ONTOLOGY_EXACT | 0.98 |
| Endoscopic Submucosal Dissection | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Early feeding | Other | — | UNRESOLVED |
| Late feeding | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Early feeding group
- description
- The group implementing early feeding (\< 24hr).
- interventionNames
- Other: Early feeding
- type
- ACTIVE_COMPARATOR
- label
- Late feeding group
- description
- The group implementing late feeding (\> 24hr).
- interventionNames
- Other: Late feeding
Primary outcomes (1)
- measure
- early post-procedural adverse events occurring within 24 hours after the procedure
- timeFrame
- Through study completion, an average of 1 year
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 19 Years
Show eligibility criteria text
Eligible patients were adults (≥19 years) scheduled to undergo colorectal ESD who met one or more of the following indications: * Differentiated early colorectal cancer ≤5 cm without ulceration and confined to the mucosa * Laterally spreading tumor ≥2 cm * Sessile polyp ≥2 cm * Adenoma with fibrosis * Differentiated early colorectal cancer without lymph node metastasis * Colorectal subepithelial lesion These indications correspond to the reimbursement criteria for colorectal ESD under the Korean National Health Insurance system. The exclusion criteria were as follows: * Untreated colorectal cancer * Active inflammatory bowel disease * Coagulopathy or prothrombin time-international normalized ratio \>1.5 despite medical correction, pregnancy * Endoscopically unmanageable perforation or bleeding during the procedure * Refusal to provide informed consent
References
Publications (12)
- BACKGROUNDSang Un Park, Dong Kyung Chang. Endoscopic Submucosal Dissection for Colorectal Tumors. Korean J Gastrointest Endosc 2010;40.
- BACKGROUNDFerlitsch M, Moss A, Hassan C, Bhandari P, Dumonceau JM, Paspatis G, Jover R, Langner C, Bronzwaer M, Nalankilli K, Fockens P, Hazzan R, Gralnek IM, Gschwantler M, Waldmann E, Jeschek P, Penz D, Heresbach D, Moons L, Lemmers A, Paraskeva K, Pohl J, Ponchon T, Regula J, Repici A, Rutter MD, Burgess NG, Bourke MJ. Colorectal polypectomy and endoscopic mucosal resection (EMR): European Society of Gastrointestinal Endoscopy (ESGE) Clinical Guideline. Endoscopy. 2017 Mar;49(3):270-297. doi: 10.1055/s-0043-102569. Epub 2017 Feb 17. PMID 28212588
- BACKGROUNDHirao M, Masuda K, Asanuma T, Naka H, Noda K, Matsuura K, Yamaguchi O, Ueda N. Endoscopic resection of early gastric cancer and other tumors with local injection of hypertonic saline-epinephrine. Gastrointest Endosc. 1988 May-Jun;34(3):264-9. doi: 10.1016/s0016-5107(88)71327-9. No abstract available. PMID 3391382
- BACKGROUNDGotoda T, Kondo H, Ono H, Saito Y, Yamaguchi H, Saito D, Yokota T. A new endoscopic mucosal resection procedure using an insulation-tipped electrosurgical knife for rectal flat lesions: report of two cases. Gastrointest Endosc. 1999 Oct;50(4):560-3. doi: 10.1016/s0016-5107(99)70084-2. No abstract available. PMID 10502182
- BACKGROUNDHosokawa K, Yoshida S. [Recent advances in endoscopic mucosal resection for early gastric cancer]. Gan To Kagaku Ryoho. 1998 Mar;25(4):476-83. Japanese. PMID 9530352
- BACKGROUNDOno H, Kondo H, Gotoda T, Shirao K, Yamaguchi H, Saito D, Hosokawa K, Shimoda T, Yoshida S. Endoscopic mucosal resection for treatment of early gastric cancer. Gut. 2001 Feb;48(2):225-9. doi: 10.1136/gut.48.2.225. PMID 11156645
- BACKGROUNDMasakatsu Fukuzawa, Takuji Gotoda. History of endoscopic submucosal dissection and role for colorectal endoscopic submucosal dissection: A Japanese perspective. Gastrointestinal Intervention 2012;1:30-35.