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Not yet recruiting NCT07696689

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

No phase Interventional Low Anterior Resection Syndrome (LARS)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Water-based transanal irrigation system.
Who it may be relevant to
Registry conditions: Low Anterior Resection Syndrome (LARS). Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

Overview

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

  • 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 minute

Primary outcome measures

  • 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]
Secondary outcome measures (5)
  • 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]
  • 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]
  • Efficacy of early administration of TAI improving quality of life at all time points [Time frame: From baseline to 9 months]
  • Efficacy of early administration of TAI improving patient satisfaction at all time points [Time frame: 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 [Time frame: From baseline to 9 months]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07696689 · 703/2025/Sper/AOUFe

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗