Ignite Creation Date:
2024-05-06 @ 2:53 PM
Last Modification Date:
2024-10-26 @ 1:39 PM
Study NCT ID:
NCT04455737
Status:
COMPLETED
Last Update Posted:
2021-08-04
First Post:
2020-06-29
Brief Title:
Ex Vivo Intra-arterial Indigo Carmine Injection After Transanal Total Mesorectal Excision
Sponsor:
Walter Brunner
Organization:
Cantonal Hospital of St Gallen
Study Overview
Official Title:
Ex Vivo Intra-arterial Indigo Carmine Injection After Transanal Total Mesorectal Excision
Status:
COMPLETED
Status Verified Date:
2021-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
RLF
Brief Summary:
Background An exact lymph node staging is essential in the treatment of rectal cancer
Objective The aim of this study was to assess the effect of indigo carmine injection on the number of retrieved and positive lymph nodes after transanal total mesorectal excision taTME
Design This is a retrospective non-randomised study Settings This study was conducted at a tertiary hospital by a multidisciplinary team
Patients Between 2013 and 2019 patients undergoing transanal total mesorectal excision were analysed Patients with indigo carmine injection intervention group were compared to those without control group
Interventions Transanal total mesorectal excision was performed with or without ex vivo intra-arterial indigo carmine injection
Main Outcome Measures The number of retrieved and positive lymph nodes was the primary outcome measure
Objective The aim of this study was to assess the effect of indigo carmine injection on the number of retrieved and positive lymph nodes after transanal total mesorectal excision taTME
Design This is a retrospective non-randomised study Settings This study was conducted at a tertiary hospital by a multidisciplinary team
Patients Between 2013 and 2019 patients undergoing transanal total mesorectal excision were analysed Patients with indigo carmine injection intervention group were compared to those without control group
Interventions Transanal total mesorectal excision was performed with or without ex vivo intra-arterial indigo carmine injection
Main Outcome Measures The number of retrieved and positive lymph nodes was the primary outcome measure
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2020-01324 | OTHER | Swissethics BASEC | None |