Early Feeding Versus Delayed Feeding After Colorectal Endoscopic Submucosal Dissection

NCT06805123 | Recruiting

• 1 other identifier: 2411-009-145
• Study Type: interventional
• Target: 204
• Locations: 1 country
• Sites: 5

Brief 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.

Conditions

Colorectal Neoplasms; Endoscopic Submucosal Dissection

Keywords

colorectum; endoscopic submucosal dissection; feeding

Outcome Measures

Primary Outcomes (1)

• Complication

  Bleeding, perforation, Post procedural coagulation syndrome

  Through study completion, an average of 1 year

Secondary Outcomes (2)

• Length of hospital stay

  through study completion, an average of 1 year

• patient satisfaction

  through study completion, an average of 1 year

Study Arms (2)

Early feeding group

EXPERIMENTAL

The group implementing early feeding (\< 24hr).

Other: Early feeding

Late feeding group

ACTIVE COMPARATOR

The group implementing late feeding (\> 24hr).

Other: Late feeding

Interventions

Early feeding OTHER

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.

Early feeding group

Late feeding OTHER

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.

Late feeding group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Pusan National University Hospital: lead

Study Sites (5)

Inje university busan paik hospital

Busan, 47392, South Korea

RECRUITING

Pusan National University Hospital

Busan, 49241, South Korea

RECRUITING

Kosin university gospel hospital

Busan, 49267, South Korea

RECRUITING

Ulsan university hospital

Ulsan, 44033, South Korea

RECRUITING

Pusan National University Yangsan Hospital

Yangsan, 50612, South Korea

RECRUITING

Related Publications (12)

• Sang Un Park, Dong Kyung Chang. Endoscopic Submucosal Dissection for Colorectal Tumors. Korean J Gastrointest Endosc 2010;40.

  BACKGROUND

• Ferlitsch 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 BACKGROUND

• Hirao 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 BACKGROUND

• Gotoda 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 BACKGROUND

• Hosokawa 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 BACKGROUND

• Ono 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 BACKGROUND

• Masakatsu Fukuzawa, Takuji Gotoda. History of endoscopic submucosal dissection and role for colorectal endoscopic submucosal dissection: A Japanese perspective. Gastrointestinal Intervention 2012;1:30-35.

  BACKGROUND

• Tanaka S, Terasaki M, Kanao H, Oka S, Chayama K. Current status and future perspectives of endoscopic submucosal dissection for colorectal tumors. Dig Endosc. 2012 May;24 Suppl 1:73-9. doi: 10.1111/j.1443-1661.2012.01252.x.

  PMID: 22533757 BACKGROUND

• Kim ER, Chang DK. Management of Complications of Colorectal Submucosal Dissection. Clin Endosc. 2019 Mar;52(2):114-119. doi: 10.5946/ce.2019.063. Epub 2019 Mar 29.

  PMID: 30959586 BACKGROUND

• Watanabe J, Watanabe J, Kotani K. Early vs. Delayed Feeding after Endoscopic Submucosal Dissection for Gastric Cancer: A Systematic Review and Meta-Analysis. Medicina (Kaunas). 2020 Nov 27;56(12):653. doi: 10.3390/medicina56120653.

  PMID: 33261059 BACKGROUND

• Weimann A, Braga M, Carli F, Higashiguchi T, Hubner M, Klek S, Laviano A, Ljungqvist O, Lobo DN, Martindale RG, Waitzberg D, Bischoff SC, Singer P. ESPEN practical guideline: Clinical nutrition in surgery. Clin Nutr. 2021 Jul;40(7):4745-4761. doi: 10.1016/j.clnu.2021.03.031. Epub 2021 Apr 19.

  PMID: 34242915 BACKGROUND

• Canzan F, Longhini J, Caliaro A, Cavada ML, Mezzalira E, Paiella S, Ambrosi E. The effect of early oral postoperative feeding on the recovery of intestinal motility after gastrointestinal surgery: a systematic review and meta-analysis of randomized clinical trials. Front Nutr. 2024 May 16;11:1369141. doi: 10.3389/fnut.2024.1369141. eCollection 2024.

  PMID: 38818132 BACKGROUND

Related Links

• Ministry for Health, Welfare and Family Affairs, National Cancer Center. National cancer information center

MeSH Terms

Conditions

Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Study Officials

• Dong Hoon Baek, MD, PhD

  Pusan National University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Seung Min Hong, MD

CONTACT

+82-10-2330-8181; lucky77i@naver.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: One group undergoes early feeding (\< 24 hours), while the other group undergoes late feeding (\> 24 hours).

Study Record Dates

• First Submitted: January 18, 2025
• First Posted: February 3, 2025
• Study Start: February 1, 2025
• Primary Completion: February 1, 2026
• Study Completion (Estimated): June 30, 2026
• Last Updated: May 5, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

KR (5)