The aim of this study is to investigate whether the high-volume transanal irrigation (TAI) performed by the Peristeen Plus® 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 Plus® 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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
20
The High-TAI (400-1000ml) will be self-performed using the Peristeen® 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.
The High-TAI (400-1000ml) will be self-performed using the Peristeen® 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.
Bellvitge University Hospital
Barcelona, Barcelona, Spain
Hospital Universitari de Bellvitge
L'Hospitalet de Llobregat, Barcelona, Spain
LARS score
LARS score changes with treatments. No LARS: 0-20; Minor LARS 21-29; Major LARS 30-42.
Time frame: day 1st, 30th, 60th, 75th, 105th, and 135th.
Daily bowel movements number (total, day, and night)
Defecation habits change with treatments
Time frame: 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)
Quality of life changes with treatments. Values between 0-100 (higher score means better outcome).
Time frame: 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).
Time frame: day 1st, 30th, 60th, 75th, 105th, and 135th.
Satisfaction grade (VAS: 0-10).
Patients' satisfaction grade related with treatments
Time frame: day 1st, 30th, 60th, 75th, 105th, and 135th.
Preferred treatments
What treatment is preferred by the patients after having tried both
Time frame: day 135
Adverse effects related to both treatments.
Adverse effects and complication directly related with one of the two treatments.
Time frame: day 1 to 135.
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