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

NCT04455737 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 189

Last updated 2021-08-04

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • Walter Brunner

    lead OTHER

Principal Investigators

  • Walter Brunner, MD MSc MBA · Kantonsspital St. Gallen, Rorschach branch, Department of Surgery

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-10-31
Primary Completion
2019-12-31
Completion
2020-06-30

Countries

  • Switzerland

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04455737 on ClinicalTrials.gov