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NCT04455737 Clinical Trial

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

Rectal Neoplasms Clinical Trial

— RLF  

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04455737
Other study ID # Chir202001
Secondary ID 2020-01324
Status Completed
Phase
First received
Last updated
Start date October 2013
Est. completion date June 2020

Study information
Verified date August 2021
Source Cantonal Hospital of St. Gallen
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 189
Est. completion date June 2020
Est. primary completion date December 2019
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

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.

Locations
Country Name City State
Switzerland Department of General, Visceral, Endocrine and Transplantation Surgery, Cantonal Hospital St. Gallen Rorschach

Sponsors (1)
Lead Sponsor Collaborator
Walter Brunner

Country where clinical trial is conducted

Switzerland, 

Outcome
Type Measure Description Time frame Safety issue
Primary retrieved lymph nodes number of lymph nodes retrieved by pathologist from the specimen 1 - 7 days after surgery
Secondary positive lymph nodes number of lymph nodes with microscopic tumor infiltration 1 - 7 days after surgery
Secondary N stage N stage according TNM version 7 1 - 7 days after surgery
Secondary survival overall survival 5 years
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