Low Anterior Resection Syndrome
Conditions
Keywords
Rectal Cancer, LARS, Low Anterior Resection Syndrome, Transanal Irrigation
Brief summary
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).
Detailed description
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.
Interventions
DEVICEPeristeen® Transanal irrigation system with the conic catheter
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.
DEVICEStandard reusable enema
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.
Sponsors
Asociacion Española de Coloproctologia
Asociación Española de Cirugía
Hospital Universitari de Bellvitge
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Personal history of LAR or ultra-LAR with total mesorectal excision (TME) and sphincter preservation with stapled or manual end to end anastomosis for primary rectal cancer. * Major LARS (score 30-42). * At least 1 year follow-up after LAR or ultra-LAR or temporary stoma closure. * Anastomotic integrity demonstrated by endoscopic, radiologic or clinical examination. * Eastern Cooperative Oncology Group (ECOG) performance status (PS) between 0-2. * Age≥ 18 years
Exclusion criteria
* Side to end mechanical anastomosis or J-pouch colorectal anastomosis * Partial or total intersphincteric resection. * Personal history of anastomotic dehiscence, chronic pelvic sepsis, anastomotic sinus, anastomotic stricture or other any other anastomotic complications. * Persona history of other colorectal, proctologic or pelvis surgery or disease. * Personal history of bariatric surgery. * Functioning sacral neurostimulator carriers. * Previous use of transanal irrigation systems for LARS treatment * Presence of an ostomy. * Local or distant rectal cancer recurrence and/or any other active neoplastic disease. * Altered cognitive status. * Pregnancy and age \< 18 years * Any other diseases that may alter results of the study. * Refusal to sign the informed consent.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| LARS score | day 1st, 30th, 60th, 75th, 105th, and 135th. | LARS score changes with treatments. No LARS: 0-20; Minor LARS 21-29; Major LARS 30-42. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Short Form 36 quality of live questionnaire (SF-36) | day 1st, 30th, 60th, 75th, 105th, and 135th. | Quality of life changes with treatments. Values between 0-100 (higher score means better outcome). |
| Vaizey score | day 1st, 30th, 60th, 75th, 105th, and 135th. | Fecal incontinence symptoms change with treatments. Values between 0-24 (higher score means worse outcome). |
| Daily bowel movements number (total, day, and night) | recorded daylily during the last 15 days at basal time and at day 60th, 75th, and 135th) | Defecation habits change with treatments |
| Preferred treatments | day 135 | What treatment is preferred by the patients after having tried both |
| Adverse effects related to both treatments. | day 1 to 135. | Adverse effects and complication directly related with one of the two treatments. |
| Satisfaction grade (VAS: 0-10). | day 1st, 30th, 60th, 75th, 105th, and 135th. | Patients' satisfaction grade related with treatments |
Countries
Spain
Outcome results
None listed