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NCT Number: NCT07696689

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

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.

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Key information

Conditions

Low Anterior Resection Syndrome (LARS) Colonic Diseases Colorectal Neoplasms Constipation Digestive System Diseases Digestive System Neoplasms Fecal Incontinence Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Low Anterior Resection Syndrome Neoplasms Neoplasms by Site Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Rectal Diseases Rectal Neoplasms Signs and Symptoms Signs and Symptoms, Digestive

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. 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.

    Time frame: 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 outcomes

  1. Efficacy of early administration of TAI in reducing the symptoms of LARS in the longterm period (up to 9 months).

    Time frame: 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.

  2. Efficacy of early administration of TAI in prevent LARS chronicity (prevent the increase of specific symptoms of LARS at all time points).

    Time frame: 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).

  3. Efficacy of early administration of TAI improving quality of life at all time points

    Time frame: 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.

  4. Efficacy of early administration of TAI improving patient satisfaction at all time points

    Time frame: 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.

  5. 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

    Time frame: 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).

Other outcomes

  1. Safety and tolerability

    Time frame: From baseline to 9 months

    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

Study contacts

Contact information is provided by the study sponsor or research team.

Simona Ascanelli Ascanelli, MD, Department of Surgery

CONTACT

[email protected]

+39 348 6909238

Sponsors and collaborators

Lead sponsor

Simona Ascanelli

Other

Registry information

Official study title

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

Acronym: EARLY-TAI

Important dates

Study start
2026
Primary completion
2028
Study completion
2029
First posted
Jul 10, 2026
Registry last updated
Jul 10, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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