Evidence map›Paper›PMID 31030266›Full record

Trial reportSurgery today2019

Antimicrobial prophylaxis for 1 day versus 3 days in liver cancer surgery: a randomized controlled non-inferiority trial.

Tadatoshi Takayama, Osamu Aramaki, Taro Shibata, Masaaki Oka, Toshiyuki Itamoto, Mitsuo Shimada, Shuji Isaji, Takashi Kanematsu, Shoji Kubo, Masato Kusunoki and 2 more

Abstract readMulticenter StudyRandomized Controlled TrialEquivalence Trial
PubMed Publisher
In one paragraph

Trial report in Surgery today, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 10 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
10citing papers in PubMed, 2 pooled it
–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

10 citing papers in PubMed, 2 syntheses or guidelines pooled it.

  1. Guideline
  2. Pooled it
  3. Article
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  5. Review
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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

12 authors.

Tadatoshi TakayamaDepartment of Digestive Surgery, Nihon University School of Medicine, 30-1 Ohyaguchikami-cho, Itabashi-ku, Tokyo, 173-8610, Japan. takayama.tadatoshi@nihon-u.ac.jp.
Osamu AramakiDepartment of Digestive Surgery, Nihon University School of Medicine, 30-1 Ohyaguchikami-cho, Itabashi-ku, Tokyo, 173-8610, Japan.
Taro ShibataBiostatistics Division, Center for Research Administration and Support, National Cancer Center, 5-1-1 Tsukiji, Chuo-ku, Tokyo, 104- 0045, Japan.
Masaaki OkaDepartment of Digestive Surgery and Surgical Oncology, Faculty of Medicine, Yamaguchi University, 1-1-1 Minami-Kogushi, Ube, Yamaguchi, 755-8505, Japan.
Toshiyuki ItamotoDepartment of Gastroenterological and Transplant Surgery, Hiroshima University School of Medicine, 1-2-3, Kasumi, Minami-Ku, Hiroshima, 734-8551, Japan.
Mitsuo ShimadaDepartment of Digestive and Transplantation Surgery, Tokushima University School of Medicine, 3-18-15, Kuramoto-cho, Tokushima, 770-8503, Japan.
Shuji IsajiDepartment of Hepatobiliary Pancreatic and Transplant Surgery, Mie University Graduate School of Medicine, 2-174 Edobashi, Tsu City, Mie, 514-8507, Japan.
Takashi KanematsuDepartment of Surgery, Nagasaki University School of Biomedical Sciences, 1-7-1 Sakamoto, Nagasaki, 852-8501, Japan.
Shoji KuboDepartment of Hepatobiliary Pancreatic Surgery, Osaka City University Graduate School of Medicine, 1-4-3 Asahi-machi, Abeno-ku, Osaka-City, Osaka, 545-8585, Japan.
Masato KusunokiDepartment of Gastrointestinal and Pediatric Surgery, Division of Reparative Medicine, Institute of Life Sciences, Mie University Graduate School of Medicine, 2-174 Edobashi, Tsu, 514-8507, Mie, Japan.
Hidetaka MochizukiDepartment of Surgery, National Defense Medical College, 3-2, Namiki, Tokorozawa, Saitama, 359-8513, Japan.
Yoshinobu SumiyamaChairman of the Board of Directors, Toho University, 5-21-16 Omori-nishi, Ota-ku, Tokyo, 143-8510, Japan.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

purposesThis study compared the effectiveness of 1-day vs 3-days antibiotic regimen to prevent surgical site infection (SSI) in open liver resection.

methodWe performed a randomized controlled non-inferiority trial in 480 patients at 39 hospitals across Japan (registered as UMIN000002852). Patients with hepatocellular carcinoma scheduled to undergo resection were randomly assigned to receive either a 1-day regimen for antimicrobial prophylaxis, or a 3-day regimen. The primary endpoint was the incidence of SSI.

resultsAmong 480 randomized patients, 232 assigned to the 1-day regimen and 235 to the 3-day regimen were included in the full analysis set. Baseline characteristics of the two groups were well balanced. SSI was diagnosed in 22 patients (9.5%) in the 1-day group vs 23 patients (9.8%) in the 3-day group (difference, - 0.30; 90% CI - 4.80 to 4.19% [95% CI - 5.66% to 5.05%]; one-sided P = 0.001 for non-inferiority), meeting the non-inferiority hypothesis. In both groups, remote site infection (16 [6.9%] vs 22 [9.4%], P ˂ 0.001 for non-inferiority) and drain-related infection (5 [2.2%] vs 4 [1.7%], P ˂ 0.001 for non-inferiority) were comparable.

conclusionTo prevent SSI in liver cancer surgery, a 1-day regimen of flomoxef sodium is recommended for antimicrobial prophylaxis because of confirming the non-inferiority to longer usage.

Indexed as

Antibiotic ProphylaxisAgedAnti-Bacterial AgentsCarcinoma, HepatocellularCephalosporinsFemaleHepatectomyHumansJapanLiver NeoplasmsMaleMiddle AgedSurgical Wound InfectionTime FactorsAnti-Bacterial AgentsCephalosporinsflomoxefAntimicrobial prophylaxisHepatocellular carcinomaLiver surgeryRandomized controlled non-inferiority trialSurgical site infection

Identifiers

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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.