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

Completed

• Conditions: Rectal Neoplasms
• Interventions: Other: injection of indigo carmine

• Registration Number: NCT04455737
• Lead Sponsor: Walter Brunner

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-10
• Primary Completion: 2019-12
• Study Completion: 2020-06
• Study First Submitted: 2020-06-29
• Study First Submitted QC: 2020-06-29
• Study First Posted: 2020-07-02
• Status Verified: 2021-08
• Last Update Submitted: 2021-08-03
• Last Update Posted: 2021-08-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 189

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients with indigo carmine stained specimen	injection of indigo carmine	Specimen which underwent pathologic work-up after ex vivo indigo carmine injection into the inferior mesenteric artery after transanal total mesorectal excision.

Primary Outcome Measures

Name	Time	Method
retrieved lymph nodes	1 - 7 days after surgery	number of lymph nodes retrieved by pathologist from the specimen

Secondary Outcome Measures

Name	Time	Method
N stage	1 - 7 days after surgery	N stage according TNM version 7
survival	5 years	overall survival
positive lymph nodes	1 - 7 days after surgery	number of lymph nodes with microscopic tumor infiltration

Trial Locations

Locations (1)

Department of General, Visceral, Endocrine and Transplantation Surgery, Cantonal Hospital St. Gallen; 🇨🇭 Rorschach, Switzerland