Assessment of Symptoms and Consequences of Coloanal Continuity Reconstruction (QUALIPRO)

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

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.

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

QLQ-C30 and QLQ-CR29 at each time defined by the study (one month before and after the first intervention, before the 2nd intervention and at 1, 3, 6 and 12 months after the 2nd intervention) Stoma-QoL before and after the 2nd intervention LARS score at 1, 3, 6 and 12 months after the 2nd intervention

Obtain an objective assessment of symptoms intensity (using the LARS score)for patients who received a proctectomy for rectal cancer ("1st intervention") following by a coloanal continuity reconstruction ("2nd intervention")

Obtain an objective assessment of symptoms intensity (using the LARS score)for patients who received a proctectomy for rectal cancer ("1st intervention") following by a coloanal continuity reconstruction ("2nd intervention")

Assess the quality of life using EORTC-QLQ-C30 questionnaires before the first intervention, between the first and the second intervention and after the second intervention

Assess the quality of life using EORTC-QLQ- CR29 questionnaires before the first intervention, between the first and the second intervention and after the second intervention

Assess the impact of stomy on quality of life for patients who received a proctectomy for rectal cancer and using Stoma-QoL questionnaire

Determinate the rate of patients with anastomotic fistula requiring the conservation of the stomy, and so they cannot undergo a coloanal continuity reconstruction

Assess the quality of life of patients who have a new stoma for functional disorder after restoration of digestive continuity .

Assess the quality of life of patients who have a new stoma for functional disorder after restoration of digestive continuity .

Assess the quality of life of patients who have a new stoma for functional disorder after restoration of digestive continuity .

Inclusion Criteria: 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 Criteria: 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