Randomised Controlled Trial of Fluorescent Urography Using Intravenous Methylene Blue Compared to White Light Alone in Left-sided Colorectal Surgery
This study will see if a blue dye (methylene blue) given into a vein, together with a special camera light, helps surgeons find the left ureter (the tube from the kidney to the bladder) faster during left-sided bowel surgery. Adults having open, laparoscopic, or robotic left-sided colorectal surgery will be randomly assigned to either the blue dye with special light or standard white light alone. The main question is whether the blue dye method finds the ureter more quickly, which could make the operation safer.
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
This randomised controlled trial will test whether intravenous methylene blue, viewed with a special fluorescence camera, helps surgeons identify the left ureter (the tube that carries urine from the kidney to the bladder) more quickly during left-sided colorectal (bowel) surgery. Ureter injury is a rare but serious complication, and in some patients the ureter is hard to see under standard white light. Adults having open, laparoscopic, or robotic left-sided colorectal surgery at Prince of Wales Hospital (Hong Kong) will be screened; if the left ureter cannot be clearly seen before dissection, they will be randomly assigned to either fluorescence imaging with methylene blue or standard white-light vision alone.
The main outcome is the time from starting dissection to first seeing the left ureter. The study will also record how often the ureter is seen at set time points, operating times, surgeon-rated ease and confidence, any changes to the surgical plan, complications, and ureteric injuries. The goal is to find out whether the fluorescence method can make ureter identification faster and easier, potentially improving safety without needing invasive preoperative ureteric stents.
Studietype
Registrering (Antatt)
Fase
- Fase 4
Kontakter og plasseringer
Studiekontakt
- Navn: Trevor Yeung, MA, MBBChir, DPhil, FRCS
- Telefonnummer: +852 3505 1495
- E-post: uretertrial@gmail.com
Studiesteder
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Hong Kong, Hong Kong
- Prince of Wales Hospital, The Chinese University of Hong Kong
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Ta kontakt med:
- Trevor Yeung, MA, MBBChir, DPhil, FRCS
- Telefonnummer: +852 3505 1495
- E-post: uretertrial@gmail.com
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-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
Inclusion Criteria:
- Aged ≥18 years
- Scheduled to undergo open, laparoscopic or robotic left-sided colorectal surgery, including 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 studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: Fluorescence Imaging with Intravenous Methylene Blue
Fluorescence Imaging with Intravenous Methylene Blue |
Intravenous methylene blue 0.5-1.0 mg/kg administered intraoperatively for fluorescence ureter identification. Modified Stryker 1688 Fluorescence Laparoscopic System with additional filter |
|
Ingen inngripen: White Light Visualisation Alone
White Light Visualisation Alone |
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Time to identification of the left ureter
Tidsramme: Intraoperative, from peritoneal incision until the ureter is first seen
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Time (in minutes) from peritoneal incision to first visualisation of the left ureter during left-sided colorectal surgery. |
Intraoperative, from peritoneal incision until the ureter is first seen
|
Samarbeidspartnere og etterforskere
Sponsor
Studierekorddatoer
Studer hoveddatoer
Studiestart (Antatt)
Primær fullføring (Antatt)
Studiet fullført (Antatt)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Andre studie-ID-numre
- Ureter MB RCT
Plan for individuelle deltakerdata (IPD)
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