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Randomized Controlled Trial
Copyright ©The Author(s) 2025. Published by Baishideng Publishing Group Inc. All rights reserved.
World J Gastrointest Surg. Nov 27, 2025; 17(11): 112557
Published online Nov 27, 2025. doi: 10.4240/wjgs.v17.i11.112557
Clinical utility of a novel concentrated enteral formula in patients undergoing colorectal cancer surgery: A randomized controlled trial
Seiichi Shinji, Takeshi Yamada, Akihisa Matsuda, Kay Uehara, Yasuyuki Yokoyama, Goro Takahashi, Takuma Iwai, Toshimitsu Miyasaka, Shintaro Kanaka, Koki Hayashi, Hiroshi Yoshida
Seiichi Shinji, Takeshi Yamada, Akihisa Matsuda, Kay Uehara, Yasuyuki Yokoyama, Goro Takahashi, Takuma Iwai, Toshimitsu Miyasaka, Shintaro Kanaka, Koki Hayashi, Hiroshi Yoshida, Department of Gastroenterological Surgery, Nippon Medical School, Bunkyo-ku 113-8603, Tokyo, Japan
Author contributions: Shinji S performed data analysis and wrote the paper; Yoshida H provided statistical guidance and supervised the study; Shinji S and Yoshida H conceptualized and designed the research; Shinji S, Yamada T, Matsuda A, Uehara K, Yokoyama Y, Takahashi G, Iwai T, Miyasaka T, Kanaka S, and Hayashi K screened patients and acquired clinical data. All authors critically revised the manuscript for important intellectual content.
Institutional review board statement: This study was reviewed and approved by the Ethics Review Committee of the Nippon Medical School Hospital, No. M-2022-048 (Tokyo, Japan).
Clinical trial registration statement: This study was registered at https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055973 (ID: No. UMIN000049138).
Informed consent statement: All individuals who participated in this study provided written informed consent before enrollment.
Conflict-of-interest statement: All the authors report no relevant conflicts of interest for this article.
CONSORT 2010 statement: The authors have read the CONSORT 2010 Statement, and the manuscript was prepared and revised according to the CONSORT 2010 Statement.
Data sharing statement: No additional data are available.
Open Access: This article is an open-access article that was selected by an in-house editor and fully peer-reviewed by external reviewers. It is distributed in accordance with the Creative Commons Attribution NonCommercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: https://creativecommons.org/Licenses/by-nc/4.0/
Corresponding author: Seiichi Shinji, MD, PhD, Associate Professor, FACS, Department of Gastroenterological Surgery, Nippon Medical School, No. 1-1-5 Sendagi, Bunkyo-ku 113-8603, Tokyo, Japan. s-shinji@nms.ac.jp
Received: July 31, 2025
Revised: August 14, 2025
Accepted: September 9, 2025
Published online: November 27, 2025
Processing time: 117 Days and 22.1 Hours
Abstract
BACKGROUND

Compared to standard hospital meals, nutritional intervention using recovery K5 (RK5), a concentrated liquid diet, offers a comprehensive immunonutritional profile, suggesting its potential effectiveness in preventing surgical site infections (SSIs) after gastrointestinal surgery.

AIM

To investigate the usefulness of RK5 in patients undergoing elective colorectal cancer surgery, focusing on postoperative infections and nutritional status.

METHODS

This single-center, open-label, randomized, parallel-group comparative trial was conducted at Department of Gastrointestinal Surgery, Nippon Medical School Hospital, between February 2023 and August 2024. Forty patients with colorectal cancer were randomly assigned in a 1:1 ratio to either the nutritional intervention or the control group. The intervention group received 800 kcal/day of RK5 administered orally instead of breakfast and dinner (400 kcal per serving) 2 days prior to surgery, whereas the control group received only standard meals. Postoperative infection, nutritional status, and bowel habits were assessed.

RESULTS

No cases of remote infection were observed. SSIs occurred in one of the 17 patients (5.9%) in the intervention group and six of the 18 patients (33.3%) in the control group, with an odds ratio of 0.125 (95% confidence interval: 0.013-1.181, P = 0.0695). Energy intake and percentage of target energy intake were significantly higher in the intervention group. No significant differences were observed between the two groups regarding nutritional status, bowel movement frequency, or the incidence of diarrhea.

CONCLUSION

Supplemental nutrition using RK5 may help prevent SSIs in patients undergoing elective colorectal cancer surgery and should be considered as a potential option for perioperative nutritional management.

Keywords: Colorectal cancer surgery; Postoperative infection; Concentrated enteral nutrition; Recovery K5; Surgical site infections

Core Tip: This study assessed the clinical utility of recovery K5 (RK5), a concentrated liquid formula, in patients undergoing elective colorectal cancer surgery. Patients receiving RK5 in addition to standard meals were compared with those receiving standard meals alone. RK5 supplementation improved target energy intake achievement and showed a trend toward reduced surgical site infections.