Evaluating the Optimal Timing of Trans-Anal Irrigation for Low Anterior Resection Syndrome Post-rectal Cancer Surgery (EARLY-TAI)

Evaluating the Optimal Timing of Trans-Anal Irrigation for Low Anterior Resection Syndrome Post-rectal Cancer Surgery - An Italian Multicentre Randomised Study

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Low Anterior Resection Syndrome (LARS)
• Intervention / Treatment: Device: Water-based transanal irrigation system

• Study Type: Interventional
• Enrollment (Estimated): 250
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Simona Ascanelli Ascanelli, MD, Department of Surgery; Phone Number: +39 348 6909238; Email: simona.ascanelli@unife.it

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Early TAI-treated group; This arm will start trans-anal irrigation within 3 months after stoma closure	Device: Water-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.
Other: Late TAI-treated group; This arm will begin trans-anal irrigation between three and six months after stoma closure	Device: Water-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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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
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

Other Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Simona Ascanelli

Study record dates

Study Major Dates

• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): December 1, 2028
• Study Completion (Estimated): June 1, 2029

Study Registration Dates

• First Submitted: June 25, 2026
• First Submitted That Met QC Criteria: July 8, 2026
• First Posted (Actual): July 10, 2026

Study Record Updates

• Last Update Posted (Actual): July 10, 2026
• Last Update Submitted That Met QC Criteria: July 8, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Keywords: Constipation; Fecal incontinence; Rectal Cancer; TAI; Low Anterior Resection Syndrome; LARS; Bowel movements; Trans-Anal Irrigation; Peristeen Plus
• Additional Relevant MeSH Terms: Postoperative Complications; Pathologic Processes; Neoplasms by Site; Neoplasms; Signs and Symptoms, Digestive; Intestinal Diseases; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colorectal Neoplasms; Intestinal Neoplasms; Rectal Diseases; Colonic Diseases; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Low Anterior Resection Syndrome; Rectal Neoplasms; Constipation; Fecal Incontinence
• Other Study ID Numbers: 703/2025/Sper/AOUFe

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No