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| Name | Class |
|---|---|
| EVAMED | OTHER |
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The purpose of this post-market clinical follow up study is to assess the efficacy on clinical symptoms of LARS of low volume Transanal Irrigation by MiniGo in conjunction with conservative treatment versus conservative treatment at 3 months.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TAI + SOC | Low volume TAI MiniGo + Standard of Care (SOC) conservative treatments | ||
| SOC | Standard of Care (SOC) conservative treatments: dietary management, counselling, medication: anti-diarrheic or constipation treatment according to the prescription following usual practice, and food supplement excluding: suppository, ano-rectal stimulation, physiotherapy small enemas, etc… |
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| Measure | Description | Time Frame |
|---|---|---|
| LARS score difference | The primary endpoint is defined by the LARS score difference between inclusion and 3-month follow-up for each randomisation group. | 3-month follow-up |
| Measure | Description | Time Frame |
|---|---|---|
| efficacy on clinical symptom of transanal Irrigation by MiniGo in improving the LARS score at 6 weeks | LARS difference score between inclusion and 6-week follow-up will be calculated for each randomised arm using descriptive statistics and confidence intervals | 6-week follow-up |
| QoL with the EORTC QLQ-C30 EORTC QLQ-CR29 |
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Inclusion Criteria:
Exclusion Criteria:
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minor and major LARS patients LARS score >= 25
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Rogini Balachandran | Contact | + 45 42 40 06 20 | rob@qufora.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU Amiens-Picardie | Recruiting | Amiens | 80054 | France |
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EORTC-QLQ-C30 and EORTC-QLQ-CR29 differences scores between inclusion and 3-month follow-up will be calculated for each randomised arm using descriptive statistics and confidence intervals. Also, statistical tests of superiority will be performed comparing EORTC-QLQ-C30 and EORTC-QLQ-CR29 differences between inclusion and 3-month follow-up between interventional arm and control arm |
| 3-month follow- up |
| change (reduction) of symptoms and consequences | To assess the number of patients showing a change (reduction) of symptoms and consequences, as stated in the consensus definition at 6 and 12 weeks The number and the proportion of patients with each item of the LARS international consensus definition at 6 and 12 weeks will be calculated. Also, the proportion of patients who are considered as having no LARS at 6 and 12 weeks will be calculated with a confidence interval | 6 weeks and 12 weeks |
| patient satisfaction | to assess the patient satisfaction at 6 and 12 weeks, The proportion of patients satisfied by the treatment evaluated with the 5-point Likert Scale at 6 and 12 weeks will be calculated with a confidence interval. | 6 weeks and 12 weeks |
| compliance of the patient to the treatmen | to assess the compliance of the patient to the treatment at 6 and 12 weeks Compliance with the treatment during the 6 and 12 weeks of study with the number of days of MiniGo use per week will be calculated using descriptive statistics and confidence intervals | 6 weeks and 12 weeks |
| incontinence anal score | To access the incontinence anal score at 12 weeks Wexner difference score between inclusion and 12-week follow-up will be calculated for each randomised arm using descriptive statistics and confidence intervals. Also, statistical tests of superiority will be performed comparing Wexner differences between inclusion and 12-week follow-up between interventional arm and control arm. | 12 weeks |
| reduction of defecations per day and night | To assess the reduction of defecations per day and night The mean number of defecations per day and per night during the week before the randomisation and the week before the follow-up visit at 6 and 12 weeks will be calculated. | 6 weeks and 12 weeks |
| time spent on bowel management (in the toilets room) | To assess the time spent on bowel management (in the toilets room) Mean times spent in the toilets room per day the week before the randomisation and the week before the follow-up visit at 12 weeks will be calculated using descriptive statistics. | 12 weeks |
| patient health organization and resources needed | To evaluate the patient health organization and resources needed at 12 weeks Data about quantity of organization and resources needed (professional activities, treatment, medical and specialize consultation, home helpers) will be presented using descriptive statistics. | 12 weeks |
| improving the LARS score | to assess the efficacy on clinical symptom of Transanal Irrigation by MiniGo in improving the LARS score at 6, 9 and 12 months LARS difference score between inclusion and 6, 9 and 12-month follow-ups will be calculated using descriptive statistics and confidence intervals. | 6, 9 and 12 months |
| number of patients showing a change (reduction) of symptoms and consequences | To assess the number of patients showing a change (reduction) of symptoms and consequences, as stated in the consensus definition at 6, 9 and 12 months The number and the proportion of patients with each item of the LARS international consensus definition at 6, 9 and 12 months will be calculated. Also, the proportion of patients who are considered as having no LARS at 6, 9 and 12 months will be calculated with a confidence interval. | 6, 9 and 12 months |
| Preference of the patient and reason for it | To assess the preference of the patient and reason for it Proportion of patients who stay on TAI treatment for TAI arm and proportion of patients from SOC arm whose tries and stay on TAI will be calculated using confidence intervals. Description of reasons will be also presented. | 12 month follow-up |
| QoL with the EORTC QLQ-C30 and EORTC QLQ-CR29 at 12 month | to assess the QoL with the EORTC QLQ-C30 and EORTC QLQ-CR29 EORTC-QLQ-C30 and EORTC-QLQ-CR29 differences scores between inclusion and 12-month follow-ups will be calculated for each randomised arm using descriptive statistics and confidence intervals. | 12-month follow-up |
| incontinence anal score at 12 months | Wexner difference score between inclusion and 12-month follow-up will be calculated for each randomised arm using descriptive statistics and confidence intervals. Also, statistical tests of superiority will be performed comparing Wexner differences between inclusion and 12-month follow-up between interventional arm and control arm | 12-month follow-up |
| patient health organization and resources needed at 6, 9 and 12 months | Data about quantity of organization and resources needed (professional activities, treatment, medical and specialize consultation, home helpers) will be presented using descriptive statistics | 6, 9 and 12 months |
| CHU Besançon | Recruiting | Besançon | 25030 | France |
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| Clinique Tivoli-Ducos | Recruiting | Bordeaux | 33000 | France |
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| CHU Grenoble | Recruiting | La Tronche | 38700 | France |
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| CHU Timone | Not yet recruiting | Marseille | 13005 | France |
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| CHU de NANTES, Hôtel Dieu | Recruiting | Nantes | 44093 | France |
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| CHU Bordeaux, GH Sud, Hôpital HAUT-LEVEQUE | Not yet recruiting | Pessac | 33604 | France |
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| CH Lyon Sud | Not yet recruiting | Pierre-Bénite | 69495 | France |
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| CHU Charles Nicolle - Rouen | Recruiting | Rouen | 76 031 | France |
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| ID | Term |
|---|---|
| D000094123 | Low Anterior Resection Syndrome |
| D012004 | Rectal Neoplasms |
| ID | Term |
|---|---|
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D012002 | Rectal Diseases |
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D015179 | Colorectal Neoplasms |
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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