Evidence map›Paper›PMID 39511580›Full record

Trial reportBMC cancer2024

Interim analysis of robot-assisted radical hysterectomy in Japan: a multicenter, prospective interventional single-arm clinical trial.

Hiroe Ito, Yoshihito Yokoyama, Satoru Kyo, Masaki Mandai, Kenzo Kosaka, Hiroaki Kobayashi, Etsuko Miyagi, Mamiko Onuki, Koji Matsumoto, Noriomi Matsumura and 3 more

Abstract readMulticenter StudyClinical Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in BMC cancer, 2024. 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. Article
  2. 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

13 authors.

Hiroe ItoDepartment of Obstetrics and Gynecology, Tokyo Medical University Hospital, Tokyo, Japan.
Yoshihito YokoyamaDepartment of Obstetrics and Gynecology, Hirosaki University Hospital, Hirosaki, Japan.
Satoru KyoDepartment of Obstetrics and Gynecology, Shimane University Faculty of Medicine, Izumo, Japan.
Masaki MandaiDepartment of Obstetrics and Gynecology, Kyoto University Hospital, Kyoto, Japan.
Kenzo KosakaDepartment of Obstetrics and Gynecology, Shizuoka General Hospital, Shizuoka, Japan.
Hiroaki KobayashiDepartment of Obstetrics and Gynecology, Kagoshima University Hospital, Kagoshima, Japan.
Etsuko MiyagiDepartment of Obstetrics and Gynecology, Yokohama City University Hospital, Yokohama, Japan.
Mamiko OnukiDepartment of Obstetrics and Gynecology, Showa University of School of Medicine, Tokyo, Japan.
Koji MatsumotoDepartment of Obstetrics and Gynecology, Showa University of School of Medicine, Tokyo, Japan.
Noriomi MatsumuraDepartment of Obstetrics and Gynecology, Kindai University Hospital, Osaka, Japan.
Kota UmemuraDepartment of Obstetrics and Gynecology, Toyohashi Municipal Hospital, Toyohashi, Japan.
Hideki IshikawaDepartment of Molecular-Targeting Cancer Prevention, Kyoto Prefectural University of Medicine, Kyoto, Japan.
Keiichi IsakaThe Robot Center, Tokyo International Ohori Hospital, 4-8-40, Shimorenjaku, Mitaka City, Tokyo, 181-0013, Japan. isaka@ohori-hosp.jp.ORCID http://orcid.org/0000-0002-8430-7266

Funding

The Intuitive Surgical company provided financial support for this statistical analysis, but not direct support. not applicable
6 · The paper itself

Abstract

objectiveTo investigate the efficacy and safety of robot-assisted radical hysterectomy (RARH) as a minimally invasive procedure in patients with cervical cancer that is curable by surgery. MATERIALS AND

methodsThis study was a multicenter, open-label, single-arm clinical trial. The short-term outcome of open radical hysterectomy was used as the historical control. The primary endpoint was successful surgery with minimal blood loss (300 mL or less) and negative surgical margins. Secondary endpoints included surgical outcomes, recurrence-free survival (RFS), and overall survival (OS) rates.

resultsOverall, 101 cases were enrolled in this study at 10 participating medical institutions and 100 underwent RARH. Among these cases, 89 met the primary endpoint, exceeding the threshold of 0.75 set by the lower limit. At 2 years postoperatively, 17 cases had recurrences, 4 were classified as International federation of Obstetrics and Gynecology Stage IB1 or lower, while 13 as IB2 or higher. There were three deaths, including one in Stage IB1 and two in Stage IIB in the second postoperative year, all of which had lymph node metastasis. The oncological outcomes for all cases showed RFS and OS rates of 82.7% and 96.9%, respectively, over a median observation period of 37 months. For cases with Stage IB1, RFS and OS were 94.1% and 98.5%, respectively.

conclusionRARH demonstrated a significant reduction in blood loss while ensuring radicality, indicating the safety and efficacy of this procedure compared to conventional RH. Although it is conceivable that the results of this oncological analysis could change, as the data collection has not been fully completed, we plan to further evaluate the oncologic outcomes of RARH in future studies.

trial registrationUMIN-CTR: UMIN000022278, registered on 11th May 2016.

Indexed as

HysterectomyRobotic Surgical ProceduresUterine Cervical NeoplasmsAdultAgedFemaleHumansJapanMiddle AgedNeoplasm Recurrence, LocalNeoplasm StagingProspective StudiesTreatment OutcomeCervical cancerClinical trialOncologic outcomeRadical hysterectomyRobot-assisted surgery

Identifiers

PMID39511580
PMCPMC11542374

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC-ND
Read underepoch 390

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.