Low Anterior Resection Syndrome (LARS)
Conditions
Keywords
LARS, Trans-Anal Irrigation, Rectal Cancer, Low Anterior Resection Syndrome, Constipation, Bowel movements, Fecal incontinence, TAI, Peristeen Plus
Brief summary
This study aims to evaluate the optimal timing of trans-anal irrigation (TAI) for participants with low anterior resection syndrome (LARS) who have undergone surgery for rectal cancer. The main question it aims to answer is: "Can starting TAI within three months of stoma closure reduce the number of daily bowel movements in people who have undergone rectal surgery?" Researchers will compare the outcomes for participants who start TAI within the first three months with those who start after three months, to see if early TAI can reduce the number of daily bowel movements more effectively than starting later. The study will also determine whether early TAI can improve typical bowel symptoms, enhance quality of life, and increase satisfaction with treatment as much as when it is performed more than three months after stoma closure. Participants will: * Undergo a preliminary visit to assess their eligibility to participate * Undergo training to understand how to use the device correctly * Perform regular TAI * Undergo four control visits at 1, 3, 6 and 9 months after the start of treatment.
Interventions
DEVICEWater-based transanal irrigation system
The procedure involves the introduction of water into the rectum and colon via the anus, which stimulates colonic reflex activity and acts as a mechanical bowel washout, thereby facilitating faecal evacuation. The device will deliver a controlled amount of warm water using a catheter - cone or balloon catheter - while sitting on the toilet. Once the desired amount of water has been introduced, the patient will expel the water and bowel contents. The procedure will take approximately 15-30 minutes, depending on the individual patient's response.
Sponsors
Simona Ascanelli
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
The study will compare the effectiveness of two treatment regimens, initiated within different time frames following ostomy closure, in reducing the number of bowel movements in 24 hours. The first regimen involves the initiation of TAI within three months from ostomy closure (early TAI group), while the second involves initiation of TAI between three and six months after ostomy closure (late TAI-treated group).
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Adults aged ≥ 18 years * Colorectal resection for rectal cancer with a protective ostomy * Integrity of the colorectal or coloanal anastomosis, as confirmed by each center's standard procedure * LARS score \> 30 (major LARS) * Not previously treated with TAI (except for enemas) * Completion of training on TAI irrigation by trained medical/nursing staff * Use of only the Peristeen® Plus device for TAI * Written informed consent
Exclusion criteria
* Neurological diseases * Psychiatric disorders * Refusal to consent to follow-up * Current or planned pregnancy * Known allergy to latex * Presence of contraindications as outlined in the device's Instructions for Use (IFU), such as ischemic colitis, acute inflammatory bowel disease, or acute diverticulitis.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Compare the effectiveness of two treatment regimens, initiated within different time frames following ostomy closure, in reducing the number of bowel movements in 24 hours. | From baseline to 3 months | The difference in the change from baseline (V0) in the number of bowel movements (i.e. defecations) in 24 hours at 3 months after stoma closure (V2) between the early TAI group and the late TAI-treated group. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Efficacy of early administration of TAI in reducing the symptoms of LARS in the longterm period (up to 9 months). | From baseline to 9 months | The difference in the change from baseline (V0) in the number of bowel movements in 24 hours at 6 and 9 months (V3 and V4) after stoma closure between the early TAI group and the late TAI-treated group. |
| Efficacy of early administration of TAI in prevent LARS chronicity (prevent the increase of specific symptoms of LARS at all time points). | From baseline to 9 months | The difference in the change from baseline (V0) in the Low Anterior Resection Syndrome (LARS) score (with a focus on the individual components of fecal urgency, incontinence, and incomplete evacuation) at various time points (V2, V3, V4) between the two groups (early TAI and late TAI-treated group). The LARS score ranges from 0 to 42 points. Patients are classified into one of three categories: no LARS (0-20 points), minor LARS (21-29 points) or major LARS (30-42 points). |
| Efficacy of early administration of TAI improving quality of life at all time points | From baseline to 9 months | Changes in quality of life (QoL) scores (across all domains of the Short Form-36 (SF-36) questionnaire) from baseline (V0) at all time points (V2, V3 and V4), and an evaluation of differences between the two groups. SF-36 scores for each domain range from 0 to 100, with higher scores indicating a more favourable health state. |
| Efficacy of early administration of TAI improving patient satisfaction at all time points | From baseline to 9 months | Change in patient satisfaction at all time points from baseline (V0) using a visual analogue scale (VAS), and evaluation of the differences between the two groups. The VAS consists of a 10 cm line with two endpoints representing 0 = completely unsatisfied and 10 = completely satisfied. |
| Evaluate how various factors, such as the timing of TAI initiation, type of anastomosis, prior neoadjuvant radio-chemotherapy, and other patient baseline characteristics, influence LARS symptoms | From baseline to 9 months | The variation in Low Anterior Resection Syndrome (LARS) scores in relation to factors such as the time at which TAI was initiated, the type of anastomosis, previous neoadjuvant radio-chemotherapy, and other baseline patient characteristics in the two groups was examined. The LARS score ranges from 0 to 42 points. Patients are classified into one of three categories: no LARS (0-20 points), minor LARS (21-29 points) or major LARS (30-42 points). |
Contacts
CONTACTSimona Ascanelli Ascanelli, MD, Department of Surgery
Outcome results
None listed