Evidence map›Paper›PMID 40739197›Full record

ArticleBMC cancer2025

Long-term prognosis of intracorporeal versus extracorporeal anastomosis in stage II/III colorectal cancer (INEX study): study protocol for a multicenter randomized controlled trial in Japan.

Marie Hanaoka, Hiroyasu Kagawa, Megumi Ishiguro, Akihiro Hirakawa, Masanori Tokunaga, Yusuke Kinugasa

Abstract readClinical Trial Protocol
In one paragraph

Article in BMC cancer, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 4 papers.

0numbers the graph read from it
0cells of the map it votes in
4citing 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

4 citing papers in PubMed.

  1. Article
  2. Essential Updates 2024-2026: Advances in Colorectal Cancer Surgery.Annals of gastroenterological surgery · 2026
    Review
  3. Article
  4. Article
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

6 authors.

Marie HanaokaDepartment of Gastrointestinal Surgery, Institute of Science Tokyo, 1-5-45 Yushima, Bunkyo-ku, Tokyo, Japan. hanasrg1@tmd.ac.jp.ORCID http://orcid.org/0000-0003-3380-7233
Hiroyasu KagawaDepartment of Gastrointestinal Surgery, Institute of Science Tokyo, 1-5-45 Yushima, Bunkyo-ku, Tokyo, Japan.
Megumi IshiguroMedical Innovation Promotion Center, Institute of Science Tokyo, 1-5-45 Yushima, Bunkyo-ku, Tokyo, Japan.
Akihiro HirakawaDepartment of Clinical Biostatistics, Institute of Science Tokyo, 1-5-45 Yushima, Bunkyo-ku, Tokyo, Japan.
Masanori TokunagaDepartment of Gastrointestinal Surgery, Institute of Science Tokyo, 1-5-45 Yushima, Bunkyo-ku, Tokyo, Japan.
Yusuke KinugasaDepartment of Gastrointestinal Surgery, Institute of Science Tokyo, 1-5-45 Yushima, Bunkyo-ku, Tokyo, Japan.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundIntracorporeal anastomosis (IA) for colon cancer has garnered attention owing to its minimally invasive nature and compatibility with advanced robot-assisted surgery. IA offers advantages such as smaller incisions, reduced postoperative pain, and quicker recovery. However, concerns persist in basic research regarding the increased risk of tumor cell dissemination due to IA, which may lead to peritoneal recurrence as a result of exposure of the intestinal lumen under high intra-abdominal pressure. Evidence regarding the long-term oncological outcomes of IA is limited, with no randomized controlled trials (RCTs) addressing this issue. Furthermore, no ongoing RCTs focus on long-term outcomes as a primary endpoint regarding two anastomosis techniques, and clinical guidelines do not currently recommend a preferred anastomotic method. This multicenter RCT aims to assess the non-inferiority of IA compared with EA in the surgery of colon cancer.

methodsThis multicenter, open-label RCT will enroll 1,400 patients with clinical stage II or III colon cancer undergoing laparoscopic or robot-assisted colectomy across 47 institutions in Japan. Eligible patients must have tumors located in the cecum, ascending, transverse, or descending colon. Participants will be randomized to receive either EA or IA. Each participating institution must have a board-certified endoscopic surgeon to ensure surgical quality. Colon resection will include D2 or D3 lymph node dissection, in accordance with the Japanese Classification of Colorectal Carcinoma. The primary endpoint is relapse-free survival, with long-term follow-up planned. DISCUSSION: This trial will be the first RCT to evaluate long-term oncological outcomes as the primary endpoint when comparing IA and EA during minimally invasive colon cancer surgery. If IA is non-inferior to EA in relapse-free survival, the choice of anastomotic technique can be tailored to the expertise of individual institutions and surgeons. Conversely, if IA fails to demonstrate non-inferiority, EA will remain the standard treatment. Given the current lack of long-term outcome data comparing IA and EA in colon cancer, this study will provide valuable insights that may influence future surgical standards and guideline recommendations.

trial registrationjRCT1032240435.

Indexed as

Anastomosis, SurgicalColectomyColorectal NeoplasmsEquivalence Trials as TopicFemaleHumansJapanLaparoscopyMaleMulticenter Studies as TopicNeoplasm Recurrence, LocalNeoplasm StagingPrognosisRandomized Controlled Trials as TopicRobotic Surgical ProceduresTreatment OutcomeColon cancerExtracorporeal anastomosisIntracorporeal anastomosisRandomized controlled trialRelapse-free survival

Identifiers

PMID40739197
PMCPMC12309057

What OpenQuestion holds

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LicenceCC BY-NC-ND
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Registered trials

None linked

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.