Ex Vivo Intra-arterial Indigo Carmine Injection After Transanal Total Mesorectal Excision (RLF)

Walter Brunner

Status: Completed

Conditions: Rectal Neoplasms

Treatments: Other: injection of indigo carmine

Study type: Observational

Funder types: Other

Identifiers

NCT04455737

2020-01324 (Other Identifier)

Chir202001

Details and patient eligibility

About

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.

Enrollment: 189 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• elective, oncologic rectum resection in TaTME technique for proven or highly suspected rectal cancer.

Exclusion criteria

• abdominoperineal resection
• extended colon resection
• previous surgery of the rectum, the left colon or the mesocolon/-rectum
• patients rejecting retrospective data analysis

Trial design

189 participants in 2 patient groups

Patients with indigo carmine stained specimen

Description:

Specimen which underwent pathologic work-up after ex vivo indigo carmine injection into the inferior mesenteric artery after transanal total mesorectal excision.

Treatment:

Other: injection of indigo carmine

Patients with unstained specimen

Description:

Specimen which underwent pathologic work-up after transanal total mesorectal excision without indigo carmine dyeing.