Assessment of Symptoms and Consequences of Coloanal Continuity Reconstruction
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Rectal Cancer
- Type
- Interventional
- Phase
- Not Applicable
- Design
- Allocation: N/AIntervention Model: Single Group AssignmentMasking: None (Open Label)Primary Purpose: Health Services Research
Participation Requirements
- Age
- Between 18 years and 70 years
- Gender
- Both males and females
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 given to each patient. The study will proceed with 2 stomatherapy consultations at one and six months ...
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 given to each patient. The study will proceed with 2 stomatherapy consultations at one and six months after coloanal continuity reconstruction. Patient care and following up will proceed as usual. The stomatherapy consultation will be done by a qualified nurse. Before the 1st intervention (proctectomy): Collect of clinical data and disease history Quality of life questionnaires (EORTC-QLQ-C30 and CR29) Evaluation of LARS score After the 1st intervention (proctectomy, at month 1): - Quality of life : EORTC-QLC30 and CR-29 questionnaires and Stom-QoL Before the 2nd intervention (coloanal continuity reconstruction): - Quality of life : EORTC-QLC30 and CR-29 questionnaires and Stom-QoL After the 2nd intervention (at month 1, month 3, month 6 and one year): at 1 and 6 months : clinical exam (stomatherapy consultation) for collect of postoperative complications Quality of life : EORTC-QLC30 and CR-29 questionnaires and LARS score
Tracking Information
- NCT #
- NCT03292289
- Collaborators
- Santélys
- Groupement Interrégional de Recherche Clinique et d'Innovation
- Investigators
- Study Director: Pascale COULON Centre Oscar Lambret