Assessment of Symptoms and Their Consequences on Patients Quality of Life After Coloanal Continuity Reconstruction Following a Proctectomy for Rectal Cancer
Overview
- Phase
- Not Applicable
- Intervention
- Pre- and post-operative consultation
- Conditions
- Rectal Cancer
- Sponsor
- Centre Oscar Lambret
- Enrollment
- 65
- Locations
- 1
- Primary Endpoint
- Quality of life 1 year after the second intervention, using LARS score
- Status
- Completed
- Last Updated
- last month
Overview
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
Investigators
Eligibility Criteria
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
Arms & Interventions
Study process
Pre- and post-operative consultations. Stomatherapy consultation. Questionnaires
Intervention: Pre- and post-operative consultation
Study process
Pre- and post-operative consultations. Stomatherapy consultation. Questionnaires
Intervention: Stomatherapy consultation
Study process
Pre- and post-operative consultations. Stomatherapy consultation. Questionnaires
Intervention: Questionnaires
Outcomes
Primary Outcomes
Quality of life 1 year after the second intervention, using LARS score
Time Frame: from baseline to 1 year after the second 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")
Secondary Outcomes
- Quality of life of patients with a second stoma placement, using EORTC-QLQ-CR29 questionnaires(From the 2nd intervention to one year after the 2nd intervention)
- Quality of life using EORTC-QLQ-C30(from baseline to one year after the 2nd intervention)
- Surgical complications description(from first intervention to one year after the 2nd intervention)
- Quality of life before the first intervention and after the second intervention(from baseline to one year after the 2nd intervention)
- Rate of patients with anastomotic fistula(from the first intervention to 6 months after the first intervention)
- Quality of life of patients with a second stoma placement, using EORTC-QLQ-C30 questionnaires(From the 2nd intervention to one year after the 2nd intervention)
- Quality of life using EORTC-QLQ-CR29 questionnaires(from baseline to one year after the 2nd intervention)
- Impact of stomy on quality of life(from the first intervention to 6 months after the first intervention)
- Quality of life of patients with a second stoma placement, using LARS score(From the 2nd intervention to one year after the 2nd intervention)