Evidence map›Paper›PMID 40415353›Full record

Trial reportColorectal disease : the official journal of the Association of Coloproctology of Great Britain and Ireland2025

A multicentre prospective study of anal function after laparoscopic ultra-low rectal cancer surgery using a mixed-effects model.

Makoto Takahashi, Kazuhiro Sakamoto, Yuichiro Tsukada, Shingo Kawano, Jun Watanabe, Yosuke Fukunaga, Yasumitsu Hirano, Hiroki Hamamoto, Masanori Yoshimitsu, Hisanaga Horie and 20 more

Abstract readMulticenter StudyClinical Trial, Phase II
In one paragraph

Trial report in Colorectal disease : the official journal of the Association of Coloproctology of Great Britain and Ireland, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing 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

2 citing papers in PubMed.

  1. A multicentre prospective study of anal function after laparoscopic ultra-low rectal cancer surgery using a mixed-effects model.Colorectal disease : the official journal of the Association of Coloproctology of Great Britain and Ireland · 2025
    Trial
  2. 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

30 authors.

Makoto TakahashiDepartment of Coloproctological Surgery, Juntendo University Faculty of Medicine, Tokyo, Japan.ORCID https://orcid.org/0000-0002-6421-5356
Kazuhiro SakamotoDepartment of Coloproctological Surgery, Juntendo University Faculty of Medicine, Tokyo, Japan.
Yuichiro TsukadaDepartment of Colorectal Surgery, National Cancer Center Hospital East, Chiba, Japan.
Shingo KawanoDepartment of Coloproctological Surgery, Juntendo University Faculty of Medicine, Tokyo, Japan.
Jun WatanabeDepartment of Surgery, Gastroenterological Center, Yokohama City University Medical Center, Yokohama, Japan.
Yosuke FukunagaDepartment of Gastroenterological Surgery, Cancer Institute Hospital, Japanese Foundation of Cancer Research, Tokyo, Japan.ORCID https://orcid.org/0000-0002-6397-0907
Yasumitsu HiranoDepartment of Gastroenterological Surgery, Saitama Medical University International Medical Center, Hidaka, Japan.
Hiroki HamamotoDepartment of General and Gastroenterological Surgery, Osaka Medical and Pharmaceutical University, Osaka, Japan.ORCID https://orcid.org/0000-0002-2294-4673
Masanori YoshimitsuDepartment of Surgery, Hiroshima City North Medical Center Asa Citizens Hospital, Hiroshima, Japan.
Hisanaga HorieDepartment of Surgery, Jichi Medical University, Tochigi, Japan.ORCID https://orcid.org/0000-0002-5907-4050
Nobuhisa MatsuhashiDepartment of Gastroenterological Surgery and Pediatric Surgery, Graduate School of Medicine, Gifu University, Gifu, Japan.
Yoshiaki KuriuDepartment of Surgery, Kyoto Prefectural University of Medicine, Kyoto, Japan.
Shuntaro NagaiDepartment of Surgery and Oncology, Graduate School of Medical Sciences, Kyushu University, Fukuoka, Japan.ORCID https://orcid.org/0000-0002-9641-830X
Madoka HamadaDepartment of Gastrointestinal Surgery, Kansai Medical University Hospital, Hirakata, Japan.
Shinichi YoshiokaDepartment of Surgery, Yao Municipal Hospital, Osaka, Japan.
Shinobu OhnumaDepartment of Surgery, Tohoku University Hospital, Sendai, Japan.
Tamuro HayamaDepartment of Surgery, Teikyo University School of Medicine, Itabashi, Japan.
Koki OtsukaDepartment of Surgery, Iwate Medical University School of Medicine, Shiwa, Iwate, Japan.
Yusuke InoueDepartment of Surgery, Graduate School of Biomedical Sciences, Nagasaki University, Nagasaki, Japan.
Kazuki UedaDivision of Endoscopic & Colorectal Surgery, Department of Surgery, Kindai University Faculty of Medicine, Osaka, Japan.
Yuji ToiyamaDepartment of Gastrointestinal and Pediatric Surgery, Mie University, Tsu, Japan.
Satoshi MaruyamaDepartment of Gastroenterological Surgery, Niigata Cancer Center Hospital, Niigata, Japan.
Shigeki YamaguchiDivision of Colorectal Surgery, Department of Surgery, Tokyo Women's Medical University, Tokyo, Japan.
Keitaro TanakaDepartment of General and Gastroenterological Surgery, Osaka Medical and Pharmaceutical University, Osaka, Japan.
Motoko SuzukiDepartment of Data Science, National Cancer Center Hospital East, Chiba, Japan.
Toshihiro MisumiDepartment of Data Science, National Cancer Center Hospital East, Chiba, Japan.
Takeshi NaitohDepartment of Lower Gastrointestinal Surgery, Kitasato University School of Medicine, Kanagawa, Japan.
Masahiko WatanabeDepartment of Surgery, Kitasato University Kitasato Institute Hospital, Tokyo, Japan.
Masaaki ItoDepartment of Colorectal Surgery, National Cancer Center Hospital East, Chiba, Japan.ORCID https://orcid.org/0000-0002-1101-2707
Ultimate Trial Group

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

aimAbdominoperineal resection with permanent colostomy has historically been performed for very low rectal cancer located near the anal canal. Anus-preserving surgeries, such as intersphincteric resection (ISR) and low anterior resection (LAR), have recently become more common. However, postoperative anal function is a concern in these surgeries when the anastomosis is very low. The aim of this study was to examine changes in anal function and factors that worsen anal function after surgery for rectal cancer.

methodA multicentre (47 facilities), non-randomized, single-arm phase II trial was conducted prospectively using the Wexner score questionnaire between 2014 and 2017. A total of 278 patients who underwent laparoscopic surgery for clinical Stage I very low rectal cancer were analysed using a mixed-effects model.

resultsAnal function temporarily worsened 3 months after surgery, but gradually recovered and spontaneously returned to an acceptable level in 3 years. In a comparison of surgical procedures, anal function was significantly better after LAR than after any type of ISR. There was little difference in anal function after total ISR, subtotal ISR and partial ISR. In the mixed-effects model analysis, ISR and older age (≥75 years) were identified as independent factors that worsened postoperative anal function.

conclusionsThe results showed early deterioration of anal function followed by gradual improvement to an acceptable level after surgery. There is a higher risk of poor postoperative anal function after ISR and in older patients, and these risk factors should be communicated to patients when obtaining consent for the surgery.

Indexed as

Anal CanalLaparoscopyPostoperative ComplicationsProctectomyRectal NeoplasmsAdultAgedAged, 80 and overFemaleHumansMaleMiddle AgedOrgan Sparing TreatmentsProspective StudiesRecovery of FunctionSurveys and Questionnairesanal functionmixed‐effects model analysisrectal cancerultimate trialWexner score

Identifiers

PMID40415353
PMCPMC12104611

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Registered trials

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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.