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| ID | Type | Description | Link |
|---|---|---|---|
| 2017-A01406-47 | Other Identifier | ANSM |
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| Name | Class |
|---|---|
| Santelys Association | OTHER |
| Groupement Interrégional de Recherche Clinique et d'Innovation | OTHER |
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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):
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):
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Study process | Experimental | Pre- and post-operative consultations. Stomatherapy consultation. Questionnaires |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pre- and post-operative consultation | Procedure | Before and between the two interventions |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Quality of life 1 year after the second intervention, using LARS score | 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") | from baseline to 1 year after the second intervention |
| Measure | Description | Time Frame |
|---|---|---|
| Quality of life before the first intervention and 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") | from baseline to one year after the 2nd intervention |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pascale COULON | Centre Oscar Lambret | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre Oscar Lambret | Lille | 59020 | France |
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| ID | Term |
|---|---|
| D012004 | Rectal Neoplasms |
| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
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| ID | Term |
|---|---|
| D007854 | Lead |
| D011795 | Surveys and Questionnaires |
| ID | Term |
|---|---|
| D019216 | Metals, Heavy |
| D004602 | Elements |
| D007287 | Inorganic Chemicals |
| D008670 | Metals |
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| Stomatherapy consultation |
| Procedure |
Clinical exam. At one and six months after the 2nd intervention |
|
| Questionnaires | Procedure |
|
|
| Quality of life using EORTC-QLQ-C30 | 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 | from baseline to one year after the 2nd intervention |
| Quality of life using EORTC-QLQ-CR29 questionnaires | 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 | from baseline to one year after the 2nd intervention |
| Impact of stomy on quality of life | Assess the impact of stomy on quality of life for patients who received a proctectomy for rectal cancer and using Stoma-QoL questionnaire | from the first intervention to 6 months after the first intervention |
| Rate of patients with anastomotic fistula | Determinate the rate of patients with anastomotic fistula requiring the conservation of the stomy, and so they cannot undergo a coloanal continuity reconstruction | from the first intervention to 6 months after the first intervention |
| Surgical complications description | Describe surgical complications linked to the coloanal continuity reconstruction | from first intervention to one year after the 2nd intervention |
| Quality of life of patients with a second stoma placement, using EORTC-QLQ-CR29 questionnaires | Assess the quality of life of patients who have a new stoma for functional disorder after restoration of digestive continuity . | From the 2nd intervention to one year after the 2nd intervention |
| Quality of life of patients with a second stoma placement, using EORTC-QLQ-C30 questionnaires | Assess the quality of life of patients who have a new stoma for functional disorder after restoration of digestive continuity . | From the 2nd intervention to one year after the 2nd intervention |
| Quality of life of patients with a second stoma placement, using LARS score | Assess the quality of life of patients who have a new stoma for functional disorder after restoration of digestive continuity . | From the 2nd intervention to one year after the 2nd intervention |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
| D003625 |
| Data Collection |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D017531 | Health Care Evaluation Mechanisms |
| D011787 | Quality of Health Care |
| D017530 | Health Care Quality, Access, and Evaluation |
| D011634 | Public Health |
| D004778 | Environment and Public Health |