Assessment of Symptoms and Consequences of Coloanal Continuity Reconstruction
- Conditions
- Rectal Cancer
- Interventions
- Procedure: Pre- and post-operative consultationProcedure: Stomatherapy consultationProcedure: Questionnaires
- Registration Number
- NCT03292289
- Lead Sponsor
- Centre Oscar Lambret
- 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
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 65
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Study process Questionnaires Pre- and post-operative consultations. Stomatherapy consultation. Questionnaires Study process Stomatherapy consultation Pre- and post-operative consultations. Stomatherapy consultation. Questionnaires Study process Pre- and post-operative consultation Pre- and post-operative consultations. Stomatherapy consultation. Questionnaires
- Primary Outcome Measures
Name Time Method Quality of life 1 year after the second intervention, using LARS score 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 Outcome Measures
Name Time Method Quality of life using EORTC-QLQ-C30 from baseline to one year after the 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
Surgical complications description from first intervention to one year after the 2nd intervention Describe surgical complications linked to the coloanal continuity reconstruction
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 Assess the quality of life of patients who have a new stoma for functional disorder after restoration of digestive continuity .
Quality of life using EORTC-QLQ-CR29 questionnaires from baseline to one year after the 2nd 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
Quality of life before the first intervention and after the second intervention from baseline to one year 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")
Rate of patients with anastomotic fistula from the first intervention to 6 months after the first intervention Determinate the rate of patients with anastomotic fistula requiring the conservation of the stomy, and so they cannot undergo a coloanal continuity reconstruction
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 Assess the quality of life of patients who have a new stoma for functional disorder after restoration of digestive continuity .
Impact of stomy on quality of life from the first intervention to 6 months after the first intervention Assess the impact of stomy on quality of life for patients who received a proctectomy for rectal cancer and using Stoma-QoL questionnaire
Quality of life of patients with a second stoma placement, using LARS score From the 2nd intervention to one year after the 2nd intervention Assess the quality of life of patients who have a new stoma for functional disorder after restoration of digestive continuity .
Trial Locations
- Locations (1)
Centre Oscar Lambret
🇫🇷Lille, France