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

NCT07696689 | Not Yet Recruiting

• 1 other identifier: 703/2025/Sper/AOUFe
• Study Type: interventional
• Target: 250
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Low Anterior Resection Syndrome (LARS)

Keywords

LARS; Trans-Anal Irrigation; Rectal Cancer; Low Anterior Resection Syndrome; Constipation; Bowel movements; Fecal incontinence; TAI; Peristeen Plus

Outcome Measures

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.

  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 Outcomes (5)

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

  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).

  From baseline to 9 months

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

  From baseline to 9 months

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

  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

  From baseline to 9 months

Other Outcomes (1)

• Safety and tolerability

  From baseline to 9 months

Study Arms (2)

Early TAI-treated group

EXPERIMENTAL

This arm will start trans-anal irrigation within 3 months after stoma closure

Device: Water-based transanal irrigation system

Late TAI-treated group

OTHER

This arm will begin trans-anal irrigation between three and six months after stoma closure

Device: Water-based transanal irrigation system

Interventions

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.

Early TAI-treated group; Late TAI-treated group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Simona Ascanelli: lead

MeSH Terms

Conditions

Low Anterior Resection Syndrome; Rectal Neoplasms; Constipation; Fecal Incontinence

Condition Hierarchy (Ancestors)

Colonic Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Rectal Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Signs and Symptoms, Digestive; Signs and Symptoms

Central Study Contacts

Simona Ascanelli Ascanelli, MD, Department of Surgery

CONTACT

+39 348 6909238; simona.ascanelli@unife.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: General Surgeon at University Hospital of Ferrara

Model Details: 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).

Study Record Dates

• First Submitted: June 25, 2026
• First Posted: July 10, 2026
• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): December 1, 2028
• Study Completion (Estimated): June 1, 2029
• Last Updated: July 10, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share