Evidence map›Paper›PMID 36882246›Full record

ArticleBMJ open2023

EffectiveNess of a multimodal preHAbilitation program in patieNts with bladder canCEr undergoing radical cystectomy: protocol of the ENHANCE multicentre randomised controlled trial.

Emine Akdemir, Maike G Sweegers, Alina Vrieling, Helene Rundqvist, Richard P Meijer, Annemarie M Leliveld-Kors, Antoine G van der Heijden, Vera C Rutten, Evert L Koldewijn, Siebe D Bos and 8 more

Registry-linked trialOpen access · goldAbstract readClinical Trial Protocol
In one paragraph

Article in BMJ open, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05480735 (EffectiveNess of a Multimodal preHAbilitation Program in patieNts With Bladder canCEr Undergoing Cystectomy. The ENHANCE Randomized Controlled Trial), which is not on this map. Cited by 8 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
8citing papers in PubMed, 3 pooled it
3.5field-weighted citation impact, top 7% 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.

NCT05480735 naunknown statusnot on this map

EffectiveNess of a Multimodal preHAbilitation Program in patieNts With Bladder canCEr Undergoing Cystectomy. The ENHANCE Randomized Controlled Trial

TypeinterventionalSponsorThe Netherlands Cancer InstituteRan2022 to 2025Enrolled154ConditionsBladder CarcinomaArmsPrehabilitation
3 · Its place in the literature

Who cites it

8 citing papers in PubMed, 3 syntheses or guidelines pooled it, 11 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Pooled it
  4. Trial
  5. Review
  6. Article
  7. Article
  8. [Role of nutrition in urological prehabilitation].Urologie (Heidelberg, Germany) · 2023
    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

18 authors at 10 institutions in 4 countries.

Emine AkdemirDivision of Psychosocial Research and Epidemiology, The Netherlands Cancer Institute, Amsterdam, The Netherlands.ORCID 0000-0003-4220-5242
Maike G SweegersDivision of Psychosocial Research and Epidemiology, The Netherlands Cancer Institute, Amsterdam, The Netherlands.
Alina VrielingDepartment for Health Evidence, Radboud University Medical Center, Nijmegen, The Netherlands.ORCID 0000-0002-8178-2125
Helene RundqvistDepartment of Laboratory Medicine, Karolinska Institutet, Stockholm, Sweden.
Richard P MeijerDepartment of Oncological Urology, University Medical Center Utrecht, Utrecht, The Netherlands.
Annemarie M Leliveld-KorsDepartment of Urology, University of Groningen, University Medical Center Groningen, Groningen, The Netherlands.
Antoine G van der HeijdenDepartment of Urology, Radboud University Medical Center, Nijmegen, The Netherlands.
Vera C RuttenDepartment of Urology, Erasmus MC Cancer Institute, Erasmus University Medical Center, Rotterdam, The Netherlands.ORCID 0000-0003-2452-5357
Evert L KoldewijnDepartment of Urology, Catharina Hospital, Eindhoven, The Netherlands.
Siebe D BosDepartment of Urology, Noordwest Hospital Group, Alkmaar, The Netherlands.
Carl J WijburgDepartment of Urology, Rijnstate Hospital, Arnhem, The Netherlands.
Tom A T MarcelissenDepartment of Urology, Maastricht University Medical Center+, Maastricht, The Netherlands.
Bart C BongersDepartment of Nutrition and Movement Sciences, Nutrition and Translational Research in Metabolism (NUTRIM), Faculty of Health, Medicine and Life Sciences, Maastricht University, Maastricht, The Netherlands.
Valesca P RetèlDivision of Psychosocial Research and Epidemiology, The Netherlands Cancer Institute, Amsterdam, The Netherlands.ORCID 0000-0002-5624-3234
Wim H van HartenDivision of Psychosocial Research and Epidemiology, The Netherlands Cancer Institute, Amsterdam, The Netherlands.
Anne M MayJulius Center for Health Sciences and Primary Care, University Medical Center Utrecht, Utrecht, The Netherlands.
Wim G GroenDepartment of Medicine for Older People, Amsterdam University Medical Center Locatie VUmc, Amsterdam, The Netherlands.
Martijn M StuiverDivision of Psychosocial Research and Epidemiology, The Netherlands Cancer Institute, Amsterdam, The Netherlands m.stuiver@nki.nl.
The Netherlands Cancer Institute · NLRadboud University Nijmegen · NLUniversity Medical Center · USUniversity Medical Center Utrecht · NLErasmus MC · NLKarolinska Institutet · SEMaastricht University · NLNoordwest Ziekenhuisgroep · NLRijnstate Hospital · NLUniversity Medical Center Groningen · NL

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionRadical cystectomy (RC) is the standard treatment for patients with non-metastatic muscle-invasive bladder cancer, as well as for patients with therapy refractory high-risk non-muscle invasive bladder cancer. However, 50-65% of patients undergoing RC experience perioperative complications. The risk, severity and impact of these complications is associated with a patient's preoperative cardiorespiratory fitness, nutritional and smoking status and presence of anxiety and depression. There is emerging evidence supporting multimodal prehabilitation as a strategy to reduce the risk of complications and improve functional recovery after major cancer surgery. However, for bladder cancer the evidence is still limited. The aim of this study is to investigate the superiority of a multimodal prehabilitation programme versus standard-of-care in terms of reducing perioperative complications in patients with bladder cancer undergoing RC. METHODS AND ANALYSIS: This multicentre, open label, prospective, randomised controlled trial, will include 154 patients with bladder cancer undergoing RC. Patients are recruited from eight hospitals in The Netherlands and will be randomly (1:1) allocated to the intervention group receiving a structured multimodal prehabilitation programme of approximately 3-6 weeks, or to the control group receiving standard-of-care. The primary outcome is the proportion of patients who develop one or more grade ≥2 complications (according to the Clavien-Dindo classification) within 90 days of surgery. Secondary outcomes include cardiorespiratory fitness, length of hospital stay, health-related quality of life, tumour tissue biomarkers of hypoxia, immune cell infiltration and cost-effectiveness. Data collection will take place at baseline, before surgery and 4 and 12 weeks after surgery. ETHICS AND DISSEMINATION: Ethical approval for this study was granted by the Medical Ethics Committee NedMec (Amsterdam, The Netherlands) under reference number 22-595/NL78792.031.22. Results of the study will be published in international peer-reviewed journals. TRIAL REGISTRATION NUMBER: NCT05480735.

Indexed as

CystectomyUrinary Bladder NeoplasmsBiomarkers, TumorEquivalence Trials as TopicHumansMulticenter Studies as TopicPreoperative ExerciseProspective StudiesQuality of LifeRandomized Controlled Trials as TopicBiomarkers, TumorNutritional supportREHABILITATION MEDICINESURGERYUrological tumours

Identifiers

PMID36882246
PMCPMC10008243
OpenAlexW4323356636

What OpenQuestion holds

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LicenceCC BY-NC
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.