Status:
COMPLETED
Assessment of Symptoms and Consequences of Coloanal Continuity Reconstruction
Lead Sponsor:
Centre Oscar Lambret
Collaborating Sponsors:
Santelys Association
Groupement Interrégional de Recherche Clinique et d'Innovation
Conditions:
Rectal Cancer
Eligibility:
All Genders
18-70 years
Phase:
NA
Brief Summary
This study is a prospective, monocentric study whose aim is to assess the quality of life for patients who underwent a coloanal continuity reconstruction and to understand the functional issues they e...
Detailed Description
First of all, an information document will be given to the patients and their consent will be collected. Then, they will be registered through the online eCRF (or by FAX) and a study number will be gi...
Eligibility Criteria
Inclusion
- 18 to 70 years old
- Patients who are going to undergo a proctectomy for a rectal cancer (situated at a distance equal or lower to 15 cm from the anoderm) following by a coloanal continuity reconstruction (using direct, latero-terminal or colonic J-pouch anastomosis)
- Already underwent or not a neoadjuvant radio-chemotherapy
- Affiliation to the National Social Security System
- With informed and signed consent
Exclusion
- Unwilling patients
- Patient deprived of their liberty or under guardianship or tutorship.
- Abdominal perineal amputation
- No stoma placement planned
- Tumor more than 15 cm from the anal margin
Key Trial Info
Start Date :
January 16 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 29 2024
Estimated Enrollment :
65 Patients enrolled
Trial Details
Trial ID
NCT03292289
Start Date
January 16 2018
End Date
July 29 2024
Last Update
December 13 2024
Active Locations (1)
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1
Centre Oscar Lambret
Lille, France, 59020