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| Name | Class |
|---|---|
| Asociacion EspaƱola de Coloproctologia | OTHER |
| AsociaciĆ³n EspaƱola de CirugĆa | UNKNOWN |
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The aim of this study is to investigate whether the high-volume transanal irrigation (TAI) performed by the Peristeen PlusĀ® system is superior to the low-volume TAI performed by standard 250ml water enema for the treatment of Low Anterior Resection Syndrome (LARS).
Most of the patients operated on for rectal cancer present defecatory disfunction symptoms known as Low Anterior Resection Syndrome (LARS) of different degree and severity. Although, transanal irrigation (TAI) has been shown to be useful in improve LARS and quality of life of these patients no evidence exists about the best way to realize TAI in terms of irrigation volume and systems and frequency of irrigation. This crossover randomized controlled trial aims to evaluate the impact of two different type of TAI (high-volume by Peristeen PlusĀ® and low-volume performed by 250ml water enema) on LARS and quality of life in patients with major LARS secondary to low anterior rectal resection (LAR) for primary rectal cancer. The primary outcome is the reduction of LARS score after two months of treatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| High-volume TAI | Active Comparator | This group will be instructed on High-volume TAI to be perform daily or every 2 days for 2 months. After 15 days of wash-out they will switch to Low-TAI treatment for 2 months. |
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| Low volume - TAI | Active Comparator | This group will be instructed on Low-volume TAI to be perform daily or every 2 days for 2 months. After 15 days of wash-out they will switch to the Low-TAI treatment for 2 months. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PeristeenĀ® Transanal irrigation system with the conic catheter | Device | The High-TAI (400-1000ml) will be self-performed using the PeristeenĀ® Transanal irrigation system with the conic catheter every 48 hours during the first two week of treatment. Then patients could change frequency and volume of TAI depending on their needs and/or preference. The Low-TAI will be self-performed using a standard 250ml water enema every 48 hours during the first two week of treatment. Then patients could change frequency of TAI depending on their needs and/or preference. |
| Measure | Description | Time Frame |
|---|---|---|
| LARS score | LARS score changes with treatments. No LARS: 0-20; Minor LARS 21-29; Major LARS 30-42. | day 1st, 30th, 60th, 75th, 105th, and 135th. |
| Measure | Description | Time Frame |
|---|---|---|
| Daily bowel movements number (total, day, and night) | Defecation habits change with treatments | recorded daylily during the last 15 days at basal time and at day 60th, 75th, and 135th) |
| Short Form 36 quality of live questionnaire (SF-36) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Loris Trenti, PhD | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Bellvitge University Hospital | Barcelona | Barcelona | 08907 | Spain | ||
| Hospital Universitari de Bellvitge |
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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 |
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| Standard reusable enema | Device | The High-TAI (400-1000ml) will be self-performed using the PeristeenĀ® Transanal irrigation system with the conic catheter every 48 hours during the first two week of treatment. Then patients could change frequency and volume of TAI depending on their needs and/or preference. The Low-TAI will be self-performed using a standard 250ml water enema every 48 hours during the first two week of treatment. Then patients could change frequency of TAI depending on their needs and/or preference. |
|
Quality of life changes with treatments.
Values between 0-100 (higher score means better outcome).
| day 1st, 30th, 60th, 75th, 105th, and 135th. |
| Vaizey score | Fecal incontinence symptoms change with treatments. Values between 0-24 (higher score means worse outcome). | day 1st, 30th, 60th, 75th, 105th, and 135th. |
| Satisfaction grade (VAS: 0-10). | Patients' satisfaction grade related with treatments | day 1st, 30th, 60th, 75th, 105th, and 135th. |
| Preferred treatments | What treatment is preferred by the patients after having tried both | day 135 |
| Adverse effects related to both treatments. | Adverse effects and complication directly related with one of the two treatments. | day 1 to 135. |
| L'Hospitalet de Llobregat |
| Barcelona |
| 08907 |
| Spain |
| 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 |