Assessment of Symptoms and Consequences of Coloanal Continuity Reconstruction

Study Overview
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Brief Summary
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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.

Detailed Description
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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

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

Conditions
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Rectal Cancer

Intervention / Treatment
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* Procedure: Pre- and post-operative consultation
* Procedure: Stomatherapy consultation
* Procedure: Questionnaires


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Study process<br>Pre- and post-operative consultations. Stomatherapy consultation. Questionnaires | Procedure: Pre- and post-operative consultation<br>* Before and between the two interventions<br>Procedure: Stomatherapy consultation<br>* Clinical exam. At one and six months after the 2nd intervention<br>Procedure: Questionnaires<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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proctectomy, coloanal continuity reconstruction