An observational study in Rectal Neoplasms, sponsored by Walter Brunner. Completed at 1 site in Switzerland. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-08-04.
Sponsored by Walter Brunner · Observational
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.
1,762 studies on the registry are indexed under Rectal Neoplasms; 518 are open to participants now.
This study's enrollment of 189 is above the median of 160 across 413 observational studies indexed under Rectal Neoplasms.
Browse Rectal Neoplasms studies →Walter Brunner is the lead sponsor of 2 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Patients undergoing elective, oncologic rectum resection in TaTME technique
Exclusion Criteria:
Specimen which underwent pathologic work-up after ex vivo indigo carmine injection into the inferior mesenteric artery after transanal total mesorectal excision.
Other: injection of indigo carmine
Specimen which underwent pathologic work-up after transanal total mesorectal excision without indigo carmine dyeing.
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.
retrieved lymph nodes
number of lymph nodes retrieved by pathologist from the specimen
Time frame: 1 - 7 days after surgery
positive lymph nodes
number of lymph nodes with microscopic tumor infiltration
Time frame: 1 - 7 days after surgery
N stage
N stage according TNM version 7
Time frame: 1 - 7 days after surgery
survival
overall survival
Time frame: 5 years
Plan to share: No
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This study is completed, as verified in Aug 2021. You cannot join it, but the record below documents what was studied.
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Walter Brunner