NCT07696689Not yet recruiting
Evaluating the Optimal Timing of Trans-Anal Irrigation for Low Anterior Resection Syndrome Post-rectal Cancer Surgery
Evaluating the Optimal Timing of Trans-Anal Irrigation for Low Anterior Resection Syndrome Post-rectal Cancer Surgery - An Italian Multicentre Randomised Study
Source: ClinicalTrials.gov · Last updated 10 Jul 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Study type
- Interventional
- Enrollment
- 250 (estimated)
- First submitted
- 25 Jun 2026
- Start date
- Sept 2026
- Primary completion date
- Dec 2028
- Lead sponsor
- Simona Ascanelli
- Diseases
- Colorectal cancer
- NCT number
- NCT07696689
What you commit to
- Study type: Interventional
- Planned participants: 250
- From Sept 2026 to the primary completion date, Dec 2028
- No sites listed in no country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Neurological diseases
- Psychiatric disorders
- 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.
Other
- Refusal to consent to follow-up
- Current or planned pregnancy
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.