- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT07861815
Assessing the Feasibility of Using Methylene Blue in Identifying Ureters During Colorectal Surgery
This study will assess whether methylene blue fluorescence imaging can help surgeons identify the ureters during colorectal surgery. Methylene blue, given through a vein during the operation, is taken up and excreted by the kidneys, allowing the ureters to appear under a special fluorescence camera system.
The study will include adults undergoing open, laparoscopic, or robotic colorectal surgery at Prince of Wales Hospital. The surgeons will compare ureter visibility using standard white light with visibility using fluorescence imaging at different stages of the operation. The study will also assess the best dose of methylene blue, the additional time required, the ease of using the imaging system, and whether the imaging findings affect the surgical plan.
The study's hypothesis is that methylene blue fluorescence imaging will make it easier or faster to identify the ureters than white light alone. The technique will be considered feasible if it is helpful in at least 20% of operations-for example, by identifying a ureter earlier or identifying it when it cannot be seen under white light. The findings will help determine whether a larger future study should be conducted.
Studieoversigt
Status
Betingelser
Intervention / Behandling
Undersøgelsestype
Tilmelding (Anslået)
Fase
- Fase 4
Kontakter og lokationer
Studiekontakt
- Navn: Trevor Yeung, MA MBBChir DPhil FRCS
- Telefonnummer: +852 3505 1495
- E-mail: uretertrial@gmail.com
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
Inclusion Criteria:
- Aged ≥18 years
- Scheduled to undergo open, laparoscopic or robotic colorectal surgery, including right colectomy, extended right colectomy, left colectomy, high anterior resection, low anterior resection, abdominoperineal resection, subtotal colectomy and total colectomy.
Exclusion Criteria:
- Unable to understand the aims and objectives of this study and unable to give consent for participation
- Known allergy to methylene blue
- Pregnant
- Taking selective serotonin reuptake inhibitors, serotonin and norepinephrine reuptake inhibitors, monoamine oxidase inhibitors, or tricyclic antidepressants (risk of serotonin syndrome)
- Significant renal or hepatic impairment
- Presence of renal or ureteric obstruction
- History of G6PD deficiency (risk of hemolytic anemia)
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Enhedens gennemførlighed
- Tildeling: N/A
- Interventionel model: Enkelt gruppeopgave
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: Methylene Blue Fluorescence Imaging Arm
Intravenous Methylene Blue with Fluorescence Imaging for Ureter Identification |
Intravenous Methylene Blue Methylene Blue Fluorescence Imaging with Custom Optical Filter (Stryker 1688) |
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Proportion of cases in which fluorescence imaging with methylene blue is deemed helpful for identifying the index ureter
Tidsramme: Intraoperative - at three predefined stages of the index operation (before dissection, before division of critical structures, and after specimen removal)
|
Intraoperative - at three predefined stages of the index operation (before dissection, before division of critical structures, and after specimen removal)
|
Samarbejdspartnere og efterforskere
Sponsor
Datoer for undersøgelser
Studer store datoer
Studiestart (Anslået)
Primær færdiggørelse (Anslået)
Studieafslutning (Anslået)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- Ureter MB Feasibility
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Studerer et amerikansk FDA-reguleret enhedsprodukt
produkt fremstillet i og eksporteret fra U.S.A.
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