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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT04455737

Acronym

RLF

Enrollment

189

Registered

2020-07-02

Start date

2013-10-31

Completion date

2020-06-30

Last updated

2021-08-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Rectal Neoplasms

Keywords

indigo carmine, lymph node, pathology

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.

Interventions

OTHERinjection of indigo carmine

Ex vivo intra-arterial injection of 20 ml indigo carmine solution (10mL, 0.4% indigo carmine with 10mL, 0.9% saline solution) in the transanal total mesorectal excision specimen via the inferior mesenteric artery.

Study design

Observational model

COHORT

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame	Description
retrieved lymph nodes	1 - 7 days after surgery	number of lymph nodes retrieved by pathologist from the specimen

Secondary

Measure	Time frame	Description
positive lymph nodes	1 - 7 days after surgery	number of lymph nodes with microscopic tumor infiltration
N stage	1 - 7 days after surgery	N stage according TNM version 7
survival	5 years	overall survival

Countries

Switzerland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026