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Evaluation of Robot-assisted Intracorporeal Urinary Reconstruction (iRARC-KSW)

11. september 2017 opdateret af: Christoph Schregel, Kantonsspital Winterthur KSW

Prospective Cohort-study for Evaluation of Clinical Outcome of Robot-assisted Cystectomy With Intracorporeal Reconstruction of Urinary Diversion

Continous evaluation of clinical and oncologic outcome of robot-assisted cystectomy with intracorporeal reconstruction of urinary diversion. Patient Data is entered in an anonymized registry for analyzation.

Studieoversigt

Status

Rekruttering

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

The registry includes patients after robot-assisted cystectomy, mainly as therapy for muscle invasive urothelial carcinoma. The urinary diversion will be completed intracorporeal either as ileal conduit or ileal neobladder. Outcome parameters include perioperative complications, oncologic data and oncologic follow-up data (tumor classification, recurrence, survival) as well as data on functional follow up (continence, quality of life).

Undersøgelsestype

Observationel

Tilmelding (Forventet)

200

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Undersøgelse Kontakt Backup

  • Navn: Orlando Burkhardt, MD
  • Telefonnummer: +41792912821

Studiesteder

  • Schweiz
      • Winterthur, Schweiz, 8401
        • Rekruttering
        • Kantonsspital Winterthur
        • Kontakt:
        • Kontakt:

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Prøveudtagningsmetode

Sandsynlighedsprøve

Studiebefolkning

Onkologic patients that qualify for radical cystectomy according to institutional tumor-board decision or patients with functional indications after failure of all other therapy modalities and receive a cystectomy

Beskrivelse

Inclusion Criteria:

  • age 18 years
  • informed consent for operation and data use
  • Oncologic patients that qualify for radical cystectomy according to institutional tumor-board decision or patients with functional indications after failure of all other therapy modalities and receive a cystectomy

Exclusion Criteria:

  • age <18 years
  • declined informed consent / data use
  • pregnancy

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Kohorter og interventioner

Gruppe / kohorte
Intervention / Behandling
Ileal Conduit
Patient with ileal conduit as reconstruction of urinary diversion after robot-assisted cystectomy
Procedure: robot-assisted cystectomy
Removal of urinary bladder in oncologic or functional setting using a assistance of a operation robotic for laparoscopy
Neobladder
Patient with neobladder, (orthotopic, continent ileal pouch) as reconstruction of urinary diversion after robot-assisted cystectomy
Procedure: robot-assisted cystectomy
Removal of urinary bladder in oncologic or functional setting using a assistance of a operation robotic for laparoscopy

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
postoperative complications
Tidsramme: 1 year
deviations from normal postoperative course ["Clavien-Dindo" Grade]
1 year

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Treatment of tumor recurrence
Tidsramme: through study completion, an average of 5 years
Treatment of tumor recurrence (radiotherapy, chemotherapy, operation)
through study completion, an average of 5 years
Quality of Life urology specific
Tidsramme: 1 year
EORTC-BLM 30 (European Organisation for Research and Treatment of Cancer Questionaire for muscle invasive bladder cancer) questionaire for evaluation of quality of life for patients with muscle invasive bladder cancer
1 year
Quality of Life overall
Tidsramme: 1 year
EORTC QLQ-C30 (European Organisation for Research and Treatment of Cancer Quality of Life Questionaire) questionaire for evaluation of quality of life for oncologic patients
1 year
Operation Time
Tidsramme: expected 4-8 hours
duration of operation [min]
expected 4-8 hours
Postoperative Death by any cause
Tidsramme: through study completion, an average of 5 years
Death by any cause [n/months]
through study completion, an average of 5 years
Pouch capacity
Tidsramme: 1 year
interventional measurement of pouch capacity with pressure recording catheter [ml]
1 year
Type of tumor-recurrence
Tidsramme: through study completion, an average of 5 years
Location of tumor recurrence (local, metastasis)
through study completion, an average of 5 years
Blood loss
Tidsramme: expected 4-8 hours
blood loss during operation [ml]
expected 4-8 hours
Time to recurrence
Tidsramme: through study completion, an average of 5 years
time until recurrence of tumor [months]
through study completion, an average of 5 years
Tumor specific death
Tidsramme: through study completion, an average of 5 years
Time to tumor specific death [months]
through study completion, an average of 5 years
Preoperative Tumor staging
Tidsramme: 90 days
Preoperative Tumor staging according UICC TNM System (Union internationale contre le cancer Tumor Nodus Metastasis System)
90 days
Postoperative Tumor staging
Tidsramme: 90 days
Postoperative Tumor staging according UICC TNM System (Union internationale contre le cancer Tumor Nodus Metastasis System)
90 days
Pouch-pressure
Tidsramme: 1 year
interventional measurement of pouch-pressure [cmH2O]with pressure recording catheter
1 year
Postvoid residual urine
Tidsramme: 1 year
Residual urin after voiding [ml]
1 year
Functional length of urethral sphincter
Tidsramme: 1 year
interventional measurement of Functional length of urethral sphincter [mm] with pressure recording catheter
1 year
Functional pressure of urethral sphincter
Tidsramme: 1 year
interventional measurement of functional pressure of urethral sphincter [cmH2O] with pressure recording catheter
1 year

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Kantonsspital Winterthur KSW

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

1. januar 2015

Primær færdiggørelse (Forventet)

1. juni 2023

Studieafslutning (Forventet)

1. juni 2023

Datoer for studieregistrering

Først indsendt

29. august 2017

Først indsendt, der opfyldte QC-kriterier

11. september 2017

Først opslået (Faktiske)

12. september 2017

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

12. september 2017

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

11. september 2017

Sidst verificeret

1. september 2017

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 2017-01260

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

UBESLUTET

IPD-planbeskrivelse

depersonalized Data may be shared with other academic centers if data security and ethical considerations equal to swiss standards are followed

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ingen

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

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Kliniske forsøg med Komplikation af kirurgisk indgreb

Kliniske forsøg med robot-assisted cystectomy

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Sponsorer og samarbejdspartnere

Medicinske tilstande

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CROs by country

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Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

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