NCT04455737

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 189 (actual)
• Sponsor: Walter Brunner · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Rectal Neoplasms

Interventions

Type	Name	Description
OTHER	injection 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.

Timeline

• Start date: 2013-10-01
• Primary completion: 2019-12-01
• Completion: 2020-06-01
• First posted: 2020-07-02
• Last updated: 2021-08-04

Locations

1 site across 1 country: Switzerland