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| ID | Type | Description | Link |
|---|---|---|---|
| 2020-01324 | Other Identifier | Swissethics BASEC |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients with indigo carmine stained specimen | Specimen which underwent pathologic work-up after ex vivo indigo carmine injection into the inferior mesenteric artery after transanal total mesorectal excision. |
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| Patients with unstained specimen | Specimen which underwent pathologic work-up after transanal total mesorectal excision without indigo carmine dyeing. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| retrieved lymph nodes | number of lymph nodes retrieved by pathologist from the specimen | 1 - 7 days after surgery |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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Patients undergoing elective, oncologic rectum resection in TaTME technique
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| Name | Affiliation | Role |
|---|---|---|
| Walter Brunner, MD MSc MBA | Kantonsspital St. Gallen, Rorschach branch, Department of Surgery | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of General, Visceral, Endocrine and Transplantation Surgery, Cantonal Hospital St. Gallen | Rorschach | 9400 | Switzerland |
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| ID | Term |
|---|---|
| D012004 | Rectal Neoplasms |
| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
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| 1 - 7 days after surgery |
| survival | overall survival | 5 years |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |