Evidence map›Paper›PMID 32347365›Full record

Trial reportLangenbeck's archives of surgery2020

Intraoperative radiotherapy for resectable advanced lower rectal cancer-final results of a randomized controlled trial (UMIN000021353).

Tadahiko Masaki, Hiroyoshi Matsuoka, Tomokazu Kishiki, Koichiro Kojima, Nobuyoshi Aso, Ayumi Beniya, Ayako Tonari, Makoto Takayama, Nobutsugu Abe, Eiji Sunami

Abstract readRandomized Controlled Trial
PubMed Publisher
In one paragraph

Trial report in Langenbeck's archives of surgery, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 6 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
6citing papers in PubMed, 1 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

6 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Pooled it
  2. Trial
  3. Review
  4. Article
  5. Review
  6. 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

10 authors.

Tadahiko MasakiDepartment of Surgery, Kyorin University Hospital, 6-20-2, Shinkawa, Mitaka City, Tokyo, 181-8611, Japan. masaki@ks.kyorin-u.ac.jp.
Hiroyoshi MatsuokaDepartment of Surgery, Kyorin University Hospital, 6-20-2, Shinkawa, Mitaka City, Tokyo, 181-8611, Japan.
Tomokazu KishikiDepartment of Surgery, Kyorin University Hospital, 6-20-2, Shinkawa, Mitaka City, Tokyo, 181-8611, Japan.
Koichiro KojimaDepartment of Surgery, Kyorin University Hospital, 6-20-2, Shinkawa, Mitaka City, Tokyo, 181-8611, Japan.
Nobuyoshi AsoDepartment of Surgery, Kyorin University Hospital, 6-20-2, Shinkawa, Mitaka City, Tokyo, 181-8611, Japan.
Ayumi BeniyaDepartment of Surgery, Kyorin University Hospital, 6-20-2, Shinkawa, Mitaka City, Tokyo, 181-8611, Japan.
Ayako TonariDepartment of Radiation Oncology, Kyorin University Hospital, 6-20-2, Shinkawa, Mitaka City, Tokyo, 181-8611, Japan.
Makoto TakayamaDepartment of Radiation Oncology, Kyorin University Hospital, 6-20-2, Shinkawa, Mitaka City, Tokyo, 181-8611, Japan.
Nobutsugu AbeDepartment of Surgery, Kyorin University Hospital, 6-20-2, Shinkawa, Mitaka City, Tokyo, 181-8611, Japan.
Eiji SunamiDepartment of Surgery, Kyorin University Hospital, 6-20-2, Shinkawa, Mitaka City, Tokyo, 181-8611, Japan.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

aimPelvic autonomic nerve preservation (PANP) is useful to preserve voiding and sexual function after rectal cancer surgery. The aim of this study was to investigate the benefit of intraoperative radiotherapy (IORT) to have complete PANP without affecting oncological outcomes.

methodsPatients undergoing potentially curative resection of the rectum were included. They were randomized to intraoperative radiotherapy of the completely preserved bilateral pelvic nerve plexuses (IORT group) or the control group without IORT, but with limited nerve preservation. The primary endpoint was pelvic sidewall recurrence. Moreover, patients' clinicopathologic parameters, postoperative complications, voiding function, and other oncologic outcomes were compared.

resultsFrom 79 patients, three were excluded from analysis, resulting in 38 patients in each group. Patients' demographic and pathological parameters were well balanced between the two groups. The trial was terminated prematurely in July 2017, because distant metastasis-free survivals were found to be significantly worse in the IORT group compared to the control group (odds ratio 2.554; 95% CI, 1.041 ~ 6.269; p = 0.041). Neither overall survival nor pelvic sidewall recurrence did differ between the two groups (overall survival: odds ratio 1.264; 95% CI, 0.523~3.051; p = 0.603/pelvic sidewall recurrence; odds ratio 1.350; 95% CI, 0.302~6.034; p = 0.694). Postoperative complications did not differ between the groups; however, the urinary function was significantly better in the IORT group in the short and long term.

conclusionWith the aid of IORT, complete PANP can be done without increase of pelvic sidewall recurrence; however, IORT may increase the incidence of distant metastases. Therefore, IORT cannot be recommended as a standard therapy to compensate less radical resection for advanced lower rectal cancer.

Indexed as

AgedCarcinomaCombined Modality TherapyFemaleHumansMaleMiddle AgedNeoplasm Recurrence, LocalOperative TimePostoperative ComplicationsRectal NeoplasmsSurvival RateTreatment OutcomeIntraoperative radiotherapyLateral lymph node dissectionPelvic autonomic nerve preservationRectal cancer

Identifiers

PMID32347365

What OpenQuestion holds

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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.