Clinical trial · Observational
Ex Vivo Intra-arterial Indigo Carmine Injection After Transanal Total Mesorectal Excision
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Rectal Neoplasms | Rectal Neoplasm | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| injection of indigo carmine | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- label
- Patients with indigo carmine stained specimen
- description
- Specimen which underwent pathologic work-up after ex vivo indigo carmine injection into the inferior mesenteric artery after transanal total mesorectal excision.
- interventionNames
- Other: injection of indigo carmine
- label
- Patients with unstained specimen
- description
- Specimen which underwent pathologic work-up after transanal total mesorectal excision without indigo carmine dyeing.
Primary outcomes (1)
- measure
- retrieved lymph nodes
- timeFrame
- 1 - 7 days after surgery
- description
- number of lymph nodes retrieved by pathologist from the specimen
Secondary outcomes (3)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available