Status:
UNKNOWN
Timing Evaluation of Stoma Closure (TIMES). Early vs Late Closure of Stoma After Rectal Cancer Surgery.
Lead Sponsor:
Hospital Universitario La Fe
Conditions:
Rectal Cancer
Total Mesorectal Excision
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The purpose of this study is to asses the safety and efficacy of early stoma closure (2-3 weeks after total mesorectal excision) vs late closure (16-24 weeks after mesorectal excision).
Detailed Description
Total mesorectal excision (TME) is considered the gold standard in obtaining a negative circumferential resection margin for cancers of the middle and lower third of the rectum. Despite all the oncolo...
Eligibility Criteria
Inclusion
- Patients with rectal cancer (with / without metastasis) (with / without chemoterapy or radiotherapy)
- Patients undergoing low or ultra low anterior resection with anastomosis and stoma of protection.
- Patients with no intraoperative or postoperative complications.
- Radiological confirmation of the absence of anastomotic compilations (opaque enema or abdominal-pelvic CT scan with rectal contrast)
- Confirmation by rectoscopy of the absence of anastomotic compilations
Exclusion
- Rectal cancer surgeries without anastomosis.
- Rectal cancer surgeries without stoma of protection.
Key Trial Info
Start Date :
January 1 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2024
Estimated Enrollment :
150 Patients enrolled
Trial Details
Trial ID
NCT05284864
Start Date
January 1 2022
End Date
December 1 2024
Last Update
March 17 2022
Active Locations (9)
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1
Complejo Hospitalario Universitario de Coruña
A Coruña, Spain
2
Hospital General Universitario de Alicante
Alicante, Spain
3
Hospital General de Elche
Elche, Spain
4
Hospital Josep Trueta
Girona, Spain