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Spots Global Cancer Trial Database for Assessment of Symptoms and Consequences of Coloanal Continuity Reconstruction

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Trial Identification

Brief Title: Assessment of Symptoms and Consequences of Coloanal Continuity Reconstruction

Official Title: Assessment of Symptoms and Their Consequences on Patients Quality of Life After Coloanal Continuity Reconstruction Following a Proctectomy for Rectal Cancer

Study ID: NCT03292289

Conditions

Rectal Cancer

Study Description

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 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.

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 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

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

Centre Oscar Lambret, Lille, , France

Contact Details

Name: Pascale COULON

Affiliation: Centre Oscar Lambret

Role: STUDY_DIRECTOR

Useful links and downloads for this trial

Clinicaltrials.gov

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