Evidence map›Paper›PMID 27209237›Full record

Trial reportBMC cancer2016

Continuous intraoperative monitoring of pelvic autonomic nerves during TME to prevent urogenital and anorectal dysfunction in rectal cancer patients (NEUROS): a randomized controlled trial.

D W Kauff, K Kronfeld, S Gorbulev, D Wachtlin, H Lang, W Kneist

2 registry-linked trialsOpen access · goldAbstract readComparative StudyMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in BMC cancer, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 12 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
12citing papers in PubMed, 3 pooled it
1.8field-weighted citation impact, top 16% of its field
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.

NCT01585727 nacompletednot on this map

Continuous Intraoperative Monitoring of the Pelvic Autonomic Nerves During Total Mesorectal Excision (TME) for the Prevention of Urogenital and Anorectal Dysfunction in Patients With Rectal Cancer.

TypeinterventionalSponsorJohannes Gutenberg University MainzRan2012 to 2018Enrolled188ConditionsRectal CancerArmsTME, Neuromonitoring
NCT04949646 narecruitingnot on this mapstarted 2021, after this paper: background citation

Intraoperative Neuromonitoring of Pelvic Autonomous Nerve Plexus During Total Mesorectal Excision

TypeinterventionalSponsorLarissa University HospitalRan2021 to 2028Enrolled44ConditionsRectal NeoplasmsArmsPelvic Intraoperative Neuromonitoring
3 · Its place in the literature

Who cites it

12 citing papers in PubMed, 3 syntheses or guidelines pooled it, 29 citations in OpenAlex.

  1. Pooled it
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  4. Article
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  10. Low anterior resection syndrome: can it be prevented?International journal of colorectal disease · 2021
    Review
  11. Optimising functional outcomes in rectal cancer surgery.Langenbeck's archives of surgery · 2021
    Review
  12. 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 at 3 institutions in 1 country.

D W KauffDepartment of General, Visceral and Transplant Surgery, University Medicine of the Johannes Gutenberg-University, Mainz, Germany.
K KronfeldInterdisciplinary Center for Clinical Trials (IZKS), University Medicine of the Johannes Gutenberg-University, Mainz, Germany.
S GorbulevInterdisciplinary Center for Clinical Trials (IZKS), University Medicine of the Johannes Gutenberg-University, Mainz, Germany.
D WachtlinBoehringer Ingelheim Pharma GmbH & Co. KG, Ingelheim, Germany.
H LangDepartment of General, Visceral and Transplant Surgery, University Medicine of the Johannes Gutenberg-University, Mainz, Germany.
W KneistDepartment of General, Visceral and Transplant Surgery, University Medicine of the Johannes Gutenberg-University, Mainz, Germany. werner.kneist@unimedizin-mainz.de.
University Medical Center of the Johannes Gutenberg University Mainz · DEJohannes Gutenberg University Mainz · DEBoehringer Ingelheim (Germany) · DE

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundUrinary, sexual and anorectal sequelae are frequent after rectal cancer surgery and were found to be related to intraoperative neurogenic impairment. Neuromonitoring methods have been developed to identify and preserve the complex pelvic autonomic nervous system in order to maintain patients' quality of life. So far no randomized study has been published dealing with the role of neuromonitoring in rectal cancer surgery. METHODS/

designNEUROS is a prospective two-arm randomized controlled multicenter clinical trial comparing the functional outcome in rectal cancer patients undergoing total mesorectal excision (TME) with and without pelvic intraoperative neuromonitoring (pIONM). A total of 188 patients will be included. Primary endpoint is the urinary function measured by the International Prostate Symptom Score. Secondary endpoints consist of sexual, anorectal functional outcome and safety, especially oncologic safety and quality of TME. Sexual function is assessed in females with the Female Sexual Function Index and in males with the International Index of Erectile Function. For evaluation of anorectal function the Wexner-Vaizey score is used. Functional evaluation is scheduled before radiochemotherapy (if applicable), preoperatively (baseline), before hospital discharge, 3 and 6 months after stoma closure and 12 months after surgery. For assessment of safety adverse events, the rates of positive resection margins and quality of mesorectum are documented. DISCUSSION: This study will provide high quality evidence on the efficacy of pIONM aiming for improvement of functional outcome in rectal cancer patients undergoing TME.

trial registrationClinicaltrials.gov: NCT01585727 . Registration date is 04/25/2012.

Indexed as

AdultAgedAged, 80 and overAnal CanalAutonomic PathwaysDigestive System Surgical ProceduresFecal IncontinenceFemaleHumansLower Urinary Tract SymptomsMaleMiddle AgedMonitoring, IntraoperativeOrgan Sparing TreatmentsPelvisPeripheral Nerve InjuriesAutonomic nervesFecal incontinenceIntraoperative monitoringQuality of lifeRectal cancerSexual dysfunctionUrinary dysfunction

Identifiers

PMID27209237
PMCPMC4875600
OpenAlexW2399883054

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

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.