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Clinical Trial 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 encounter. This will potentially provide predictive factors identification of bad functional outcomes allowing to guide future decisions. Also, it will allow patients to have a reinforced follow-up during the year after the reconstruction.


Clinical Trial 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 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 ;


Study Design


Related Conditions & MeSH terms


NCT number NCT03292289
Study type Interventional
Source Centre Oscar Lambret
Contact
Status Active, not recruiting
Phase N/A
Start date January 16, 2018
Completion date July 2024

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