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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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Early TAI-treated group | Experimental | This arm will start trans-anal irrigation within 3 months after stoma closure |
|
| Late TAI-treated group | Other | This arm will begin trans-anal irrigation between three and six months after stoma closure |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Water-based transanal irrigation system | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 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. | From baseline to 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Efficacy of early administration of TAI in reducing the symptoms of LARS in the longterm period (up 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. | From baseline to 9 months |
| Measure | Description | Time Frame |
|---|---|---|
| Safety and tolerability | Evaluation of the frequency and severity of adverse events (AEs), serious adverse events (SAEs), devicerelated adverse events (ADEs) and serious device-related adverse events (SADEs) in the two groups | From baseline to 9 months |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Simona Ascanelli Ascanelli, MD, Department of Surgery | Contact | +39 348 6909238 | simona.ascanelli@unife.it |
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| ID | Term |
|---|---|
| D000094123 | Low Anterior Resection Syndrome |
| D012004 | Rectal Neoplasms |
| D003248 | Constipation |
| D005242 | Fecal Incontinence |
| ID | Term |
|---|---|
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
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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).
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|
| Efficacy of early administration of TAI in prevent LARS chronicity (prevent the increase of specific symptoms of LARS at all time points). | 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). | From baseline to 9 months |
| Efficacy of early administration of TAI improving quality of life at all time points | 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. | From baseline to 9 months |
| Efficacy of early administration of TAI improving patient satisfaction at all time points | 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. | From baseline to 9 months |
| 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 | 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). | From baseline to 9 months |
| 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 |
| D012817 | Signs and Symptoms, Digestive |
| D012816 | Signs and Symptoms |