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

Study Overview
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Brief Summary
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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.

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

Conditions
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Rectal Neoplasms

Intervention / Treatment
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* Other: injection of indigo carmine


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients with indigo carmine stained specimen<br>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<br>* 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.<br>|
| Patients with unstained specimen<br>Specimen which underwent pathologic work-up after transanal total mesorectal excision without indigo carmine dyeing. | |

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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pathology, indigo carmine, lymph node