Status:
TERMINATED
The Stoma Closure Before or After Adjuvant Therapy Trial
Lead Sponsor:
Ospedale Umberto I di Torino
Collaborating Sponsors:
Rete Oncologica Piemonte, Valle d'Aosta
Conditions:
Ileostomy
Rectal Cancer
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
This is an open-label multicenter controlled trial, including 28 centers from the Rete Oncologica (Oncological Network) of Piemonte and Valle d'Aosta in Italy (http://www.reteoncologica.it). After a c...
Detailed Description
Diverting ileostomy is effective in reducing severity of anastomotic complications in rectal low anterior resections and it is therefore widely used especially after neoadjuvant chemoradiation treatme...
Eligibility Criteria
Inclusion
- Patient treated with a curative resection for rectal cancer
- Presence of a temporary ileostomy
- Age \>= 18 years
- Indication to adjuvant treatment
- Absence of anastomotic dehiscence (as proved by enema and/or endoscopy)
- Able to give written informed consent
Exclusion
- ASA \>3
- ECOG Performance Status \>=2
- UICC stage IV
- Severe and non-controlled systemic, oncologic, or infectious disease
Key Trial Info
Start Date :
September 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2022
Estimated Enrollment :
14 Patients enrolled
Trial Details
Trial ID
NCT04372992
Start Date
September 1 2020
End Date
September 1 2022
Last Update
September 22 2022
Active Locations (28)
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1
Ospedale Mons. Galliano - Chirurgia Generale (Dott. Serventi)
Acqui Terme, AL, Italy
2
Ospedale SS. Antonio e Biagio - Chirurgia Generale (Dott. Priora)
Alessandria, AL, Italy
3
Ospedale S. Spirito - Chirurgia Generale (Dott. Amisano)
Casale Monferrato, AL, Italy
4
Ospedale S. Giacomo - Chirurgia Generale (Dott. Di Somma)
Novi Ligure, AL, Italy