Evidence map›Paper›PMID 36639814›Full record

ArticlePilot and feasibility studies2023

Robot-assisted laparoscopic radical cystectomy with intracorporeal ileal conduit diversion versus open radical cystectomy with ileal conduit for bladder cancer in an ERAS setup (BORARC): protocol for a single-centre, double-blinded, randomised feasibility study.

Sophia Liff Maibom, Ulla Nordström Joensen, Eske Kvanner Aasvang, Malene Rohrsted, Peter Ole Thind, Per Bagi, Thomas Kistorp, Alicia Martin Poulsen, Lisbeth Nerstrøm Salling, Henrik Kehlet and 2 more

Registry-linked trialOpen access · goldAbstract read
PubMed Full text at PMC Publisher
In one paragraph

Article in Pilot and feasibility studies, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03977831 (A Controlled Blinded Randomized Feasibility Study of Open Radical Cystectomy), which is not on this map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
0.6field-weighted citation impact, top 33% 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.

NCT03977831 nacompletednot on this map

A Controlled Blinded Randomized Feasibility Study of Open Radical Cystectomy (ORC) Versus Robot-Assisted Radical Cystectomy With Intracorporal Urinary Diversion (iRARC) Under an Enhanced Recovery After Surgery (ERAS) Setup

TypeinterventionalSponsorRigshospitalet, DenmarkRan2019 to 2021Enrolled50ConditionsUrinary Bladder NeoplasmsArmsRadical Cystectomy
3 · Its place in the literature

Who cites it

1 citing paper in PubMed, 2 citations in OpenAlex.

  1. 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

12 authors at 1 institution in 1 country.

Sophia Liff MaibomUrological Research Unit, Department of Urology, Faculty of Health and Medical Sciences, University of Copenhagen, Rigshospitalet, Copenhagen, Denmark. d034920@dadlnet.dk.ORCID http://orcid.org/0000-0002-5489-2521
Ulla Nordström JoensenUrological Research Unit, Department of Urology, Faculty of Health and Medical Sciences, University of Copenhagen, Rigshospitalet, Copenhagen, Denmark.
Eske Kvanner AasvangDepartment of Anaesthesiology, Centre for Cancer and Organ Diseases, University of Copenhagen, Rigshospitalet, Copenhagen, Denmark.
Malene RohrstedUrological Research Unit, Department of Urology, Faculty of Health and Medical Sciences, University of Copenhagen, Rigshospitalet, Copenhagen, Denmark.
Peter Ole ThindUrological Research Unit, Department of Urology, Faculty of Health and Medical Sciences, University of Copenhagen, Rigshospitalet, Copenhagen, Denmark.
Per BagiUrological Research Unit, Department of Urology, Faculty of Health and Medical Sciences, University of Copenhagen, Rigshospitalet, Copenhagen, Denmark.
Thomas KistorpDepartment of Anaesthesiology, Centre for Cancer and Organ Diseases, University of Copenhagen, Rigshospitalet, Copenhagen, Denmark.
Alicia Martin PoulsenUrological Research Unit, Department of Urology, Faculty of Health and Medical Sciences, University of Copenhagen, Rigshospitalet, Copenhagen, Denmark.
Lisbeth Nerstrøm SallingUrological Research Unit, Department of Urology, Faculty of Health and Medical Sciences, University of Copenhagen, Rigshospitalet, Copenhagen, Denmark.
Henrik KehletSection of Surgical Pathophysiology, University of Copenhagen, Rigshospitalet, Copenhagen, Denmark.
Klaus BrassoUrological Research Unit, Department of Urology, Faculty of Health and Medical Sciences, University of Copenhagen, Rigshospitalet, Copenhagen, Denmark.
Martin Andreas RøderUrological Research Unit, Department of Urology, Faculty of Health and Medical Sciences, University of Copenhagen, Rigshospitalet, Copenhagen, Denmark.
University of Copenhagen · DK

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundRadical cystectomy (RC) with urinary diversion is the recommended treatment for selected cases of non-metastatic high-risk non-muscle-invasive and muscle-invasive bladder cancer. It remains unknown whether robot-assisted laparoscopic cystectomy (RARC) offers any advantage in terms of safety compared to open cystectomy (ORC) in an Enhanced Recovery After Surgery (ERAS) setup. Blinded randomised controlled trials (RCTs) between RARC versus ORC have never been conducted in cystectomy patients. We will investigate the feasibility of conducting a double-blinded RCT comparing ORC with RARC with intra-corporal ileal conduit (iRARC) in an ERAS setup.

methodsThis is a single-centre, double-blinded, randomised (1:1) clinical feasibility study for patients with non-metastatic high-risk non-muscle-invasive or muscle-invasive bladder cancer scheduled for cystectomy. All participants are recruited from Rigshospitalet, Denmark. The planned sample size is 50 participants to investigate whether blinding of the surgical technique is feasible. Participants and postoperative caring physicians and nurses are blinded using a pre-study designed abdominal dressing and blinding of the patient's electronic health record. Study endpoints are assessed 90 days postoperatively. The primary aim is to study the frequency and pattern of unplanned unblinding after surgery and the number of participants who cannot guess the surgical technique at the day of discharge. Eleven secondary endpoints are assessed: length of stay, days alive and out of hospital, in-hospital complication rate, 30-day complication rate, 90-day complication rate, readmission rate, quality of life, blood loss, pain, rate of moderate/severe post-anaesthesia care unit (PACU) complications, and delirium. Participants are managed in an ERAS setup in both arms of the trial. DISCUSSION: We report on the design and objectives of a novel experimental feasibility study investigating whether blinding of the surgical technique in cystectomy patients is possible. This information is essential for the design of future blinded trials comparing ORC to RARC. There is a continued need to compare RARC and ORC in terms of both efficacy, safety, and oncological outcomes. Estimated end of study is March 2021.

trial registrationClinicalTrials.gov ID: NCT03977831. Registered on the 6th of June 2019.

Indexed as

Bladder cancerBlindingOpen surgeryRadical cystectomyRandomised controlled trialRobotic surgeryUrothelial carcinoma

Identifiers

PMID36639814
PMCPMC9838067
OpenAlexW4316041476

What OpenQuestion holds

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LicenceCC BY
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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.