Evidence map›Paper›PMID 41024239›Full record

ArticleTrials2025

Efficacy of preoperative immunonutrition in malnourished patients undergoing colorectal cancer surgery: a study protocol for a multicenter randomized clinical trial.

Soo Young Lee, Chang Hyun Kim, Gi Won Ha, Soo Yeun Park, In Jun Yang, Jin Soo Kim, Gyung Mo Son, Sung Il Kang, Sung Uk Bae, Korean ColoRectal surgeOn Study group of the Southern province (K-CROSS)

Abstract readClinical Trial Protocol
PubMed Full text at PMC Publisher
In one paragraph

Article in Trials, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

3 citing papers in PubMed.

  1. Trial
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  3. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

10 authors.

Soo Young LeeDepartment of Surgery, Chonnam National University Hwasun Hospital and Medical School, 322 Seoyang-Ro Hwasun-Eup, Hwasun, Jeonnam, 58128, South Korea.
Chang Hyun KimDepartment of Surgery, Chonnam National University Hwasun Hospital and Medical School, 322 Seoyang-Ro Hwasun-Eup, Hwasun, Jeonnam, 58128, South Korea. cksantiago8@gmail.com.ORCID http://orcid.org/0000-0002-1954-189X
Gi Won HaResearch Institute of Clinical Medicine of Jeonbuk National University-Biomedical Research Institute of Jeonbuk National University Hospital, Jeonju, Jeonbuk, South Korea.
Soo Yeun ParkColorectal Cancer Center, Kyungpook National University Chilgok Hospital, School of Medicine, Kyungpook National University, Daegu, South Korea.
In Jun YangDepartment of Surgery, Chungnam National University Hospital & College of Medicine, Chungnam National University, Daejeon, South Korea.
Jin Soo KimDepartment of Surgery, Chungnam National University Sejong Hospital & College of Medicine, Chungnam National University, Daejeon, South Korea.
Gyung Mo SonDepartment of Surgery, Pusan National University Yangsan Hospital, School of Medicine, Pusan National University, Yangsan, South Korea.
Sung Il KangDepartment of Surgery, College of Medicine, Yeungnam University, Daegu, South Korea.
Sung Uk BaeDepartment of Surgery, School of Medicine, Keimyung University and Dongsan Medical Center, Daegu, South Korea.
Korean ColoRectal surgeOn Study group of the Southern province (K-CROSS)

Funding

Chonnam National University Hwasun Hospital, Institute for Biomedical Science HCRI2302Korean Society of Coloproctology KSCP-CA202402
6 · The paper itself

Abstract

backgroundMalnutrition is a significant risk factor for postoperative complications in patients undergoing colorectal cancer surgery. Although current guidelines recommend preoperative immunonutrition for malnourished patients, its clinical benefit remains controversial. Our previous randomized clinical trial assessing immunonutrition in unselected colon cancer patients showed no reduction in infectious complications. This study aims to evaluate the efficacy of preoperative immunonutrition in reducing postoperative complications in malnourished patients undergoing colorectal cancer surgery.

methodsThis multicenter, parallel, superiority, randomized clinical trial will include patients with primary colorectal cancer and Nutritional Risk Screening (NRS) 2002 score of 3-5 from eight participating institutions. Patients will be randomly assigned (1:1) to receive either preoperative immunonutrition with oral nutritional supplements (400 mL/day) containing arginine and ω-3 fatty acids for 7 days before surgery (intervention group) or a standard preoperative diet alone (control group). The primary endpoint is the rate of infectious complications within 30 days postoperatively. Secondary endpoints include overall postoperative complication rate, length of hospital stay, perioperative body weight changes, and alterations in nutritional and immune response markers (serum transferrin, prealbumin, albumin, cytokines, prostaglandin E2, high-sensitivity C-reactive protein). A sample size of 176 patients (88 per arm) was determined to detect a significant reduction in infectious complications from 30% (control) to 12% (intervention), with 80% power and a two-sided α of 0.05. DISCUSSION: This study addresses a critical gap in evidence by focusing on nutritionally at-risk colorectal cancer patients. Unlike previous trials on unselected populations, this trial specifically evaluates the impact of immunonutrition in a high-risk group in which nutritional optimization may yield clinical benefits. Additionally, the multicenter design enhances generalizability. If preoperative immunonutrition effectively reduces postoperative complications, it could support a targeted nutritional intervention strategy for malnourished colorectal cancer patients, optimizing perioperative care and potentially reducing the healthcare burden.

trial registrationClinical Research Information Service KCT0008382. Registered on April 25, 2023.

Indexed as

Colorectal NeoplasmsDietary SupplementsMalnutritionPostoperative ComplicationsPreoperative CareArginineEquivalence Trials as TopicFatty Acids, Omega-3FemaleHumansImmunonutrition DietLength of StayMaleMulticenter Studies as TopicNutritional StatusRisk FactorsArginineFatty Acids, Omega-3Colorectal cancerComplicationsImmunonutritionInfectionMalnutrition

Identifiers

PMID41024239
PMCPMC12482491

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.