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Completed

NCT Number: NCT04455737

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

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.

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Key information

Conditions

Rectal Neoplasms Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Neoplasms Neoplasms by Site Rectal Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Department of General, Visceral, Endocrine and Transplantation Surgery, Cantonal Hospital St. Gallen

Rorschach, 9400, Switzerland

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

injection of indigo carmine

Other

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.

Primary outcomes

  1. retrieved lymph nodes

    Time frame: 1 - 7 days after surgery

    number of lymph nodes retrieved by pathologist from the specimen

Secondary outcomes

  1. positive lymph nodes

    Time frame: 1 - 7 days after surgery

    number of lymph nodes with microscopic tumor infiltration

  2. N stage

    Time frame: 1 - 7 days after surgery

    N stage according TNM version 7

  3. survival

    Time frame: 5 years

    overall survival

Sponsors and collaborators

Lead sponsor

Walter Brunner

Other

Registry information

Acronym: RLF

Important dates

Study start
2013
Primary completion
2019
Study completion
2020
First posted
Jul 2, 2020
Registry last updated
Aug 4, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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