- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT04715308
Patient Experiences Following Urinary Diversion as Part of Surgery for Advanced and Recurrent Rectal Cancer (Pelvex 3)
6. februar 2021 opdateret af: Professor Des Winter, St Vincent's University Hospital, Ireland
Surgical and Patient-entered Experiences Following Urinary Reconstruction After Pelvic Exenteration for Locally Advanced and Recurrent Rectal Cancer
The outcomes of patients who undergo radical surgery for locally advanced and recurrent rectal cancer have improved vastly, but there is a lack of emphasis on the quality-of-life outcomes of these patients.
This study will assess the patient experience of having a stoma for urinary diversion as part of surgery for advanced pelvic malignancy.
This will be assessed at regular intervals both before and after surgery with the goal of increasing awareness of patient beliefs and concerns with regards to their stomas and to devise interventions that will improve their quality-of-life.
Studieoversigt
Status
Rekruttering
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
Considerable progress has been made in the management of advanced and recurrent pelvic cancer over the last few decades.
However, much emphasis has been placed on surgical and hospital-related outcomes.
In recent years, there has been an increased focus on patient quality-of-life following major abdominopelvic surgery.
However, there is a lack of updated evidence on how patients manage and perceive their stomas.
Managing a stoma is a difficult task for patients and can adversely effect their quality-of-life.
This study will investigate specifically the impact of managing a urostomy or ileal conduit.
Patients will be contacted via an anonymized, opt-in SMS or email to answer a questionnaire, having previously been provided with a patient information leaflet.
This will take approximately 5 minutes to complete and will be carried out just prior to and at 1, 3, 6, 9 and 12 months post-operatively.
All of this data will be collated and published as part of a wider investigation in to patient quality-of-life following major abdominal and pelvic surgery.
This study will be carried out in 35 countries.
Undersøgelsestype
Observationel
Tilmelding (Forventet)
1200
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiekontakt
- Navn: Matthew Fahy, MB
- Telefonnummer: 00353874510237
- E-mail: MFahy94@gmail.com
Undersøgelse Kontakt Backup
- Navn: Michael Kelly, MD
- E-mail: kellym11@tcd.ie
Studiesteder
-
-
-
Dublin, Irland, D4
- Rekruttering
- St. Vincent's Hospital
-
Kontakt:
- Des Winter, MD
- E-mail: pelvexcollaborative@gmail.com
-
-
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
Ikke-sandsynlighedsprøve
Studiebefolkning
Cohort of patients who are undergoing surgery for locally advanced or recurrent rectal cancer and are undergoing a urinary diversion or reconstruction.
Beskrivelse
Inclusion Criteria:
- Histologically-proven advanced rectal cancer
- Has undergone urinary diversion/reconstruction
- Aged 18 years or older
- Able and willing to give written, informed consent
- Able to access email/internet
Exclusion Criteria:
- Strong evidence of metastatic or peritoneal disease
- Palliative exenteration
- Non-rectal origin of primary tumour
- Colonic obstruction
- Inability to answer online questionnaire
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Observationsmodeller: Kohorte
- Tidsperspektiver: Fremadrettet
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
To determine the 30-day complication rate of urinary diversion/reconstruction following pelvic exenteration
Tidsramme: 2 years
|
Morbidity of urinary diversion/reconstruction
|
2 years
|
To assess the impact of urinary diversion/reconstruction subtypes on quality-of-life
Tidsramme: Before surgery and at 1, 3, 6, 9 and 12 months respectively
|
Patient-reported outcomes assessing their quality-of-life
|
Before surgery and at 1, 3, 6, 9 and 12 months respectively
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
To assess the longer-term complications associated with urinary diversion/reconstruction
Tidsramme: 1 month - 12 months
|
Morbidity of urinary diversion or reconstruction over longer than 1 month but less than 1 year
|
1 month - 12 months
|
To measure the rate of reintervention for complications associated with urinary diversion/reconstruction
Tidsramme: 12 months
|
Rate of reintervention
|
12 months
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
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. december 2020
Primær færdiggørelse (Forventet)
1. december 2021
Studieafslutning (Forventet)
1. marts 2022
Datoer for studieregistrering
Først indsendt
14. januar 2021
Først indsendt, der opfyldte QC-kriterier
14. januar 2021
Først opslået (Faktiske)
20. januar 2021
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
10. februar 2021
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
6. februar 2021
Sidst verificeret
1. februar 2021
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- STVINCENTSIRELAND
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
Ingen
IPD-planbeskrivelse
No individual patient date other than their responses to the questionnaire will be collected or shared.
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Ingen
Studerer et amerikansk FDA-reguleret enhedsprodukt
Ingen
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .
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