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Transanal Irrigation for the Management of Early Low Anterior Resection Syndrome (LARS)

ConditionsColorectal CancerLow Anterior Resection Syndrome
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorCase Comprehensive Cancer Center

About this trial

Transanal irrigation (TAI) has shown to improve fecal incontinence and increase quality of life in patients with low anterior resection syndrome (LARS). This trial is a small study being conducted to determine whether a larger trial is feasible. Investigators are also doing this research to see if TAI impacts quality of life and improves bowel function within the early post-operative period (1-12 months).

This treatment is designed for participants to have more control over their bowel movements and reduce the dependency on immediate access to the toilet.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Adults (≥18 years-old) patients who underwent a LAR for any indication via open, laparoscopic, robotic, or transanal total mesorectal excision, with creation of a diverting loop ileostomy,

have confirmed anastomotic healing demonstrated by flexible sigmoidoscopy and CT scan with rectally-administered water soluble contrast or gastrograffin enema,

are planned for an ileostomy closure operation, and

are in the first 12 months post-LAR operation

Disqualifiers

Inability to comprehend English or Spanish or provide informed consent (Note: after the English documents are approved, the study team plans to obtain a Spanish consent and study documents),

ongoing chemotherapy or radiotherapy, and

ongoing anastomotic complication.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Peristeen Plus Irrigation kit

    Device

    Transanal irrigation TAI is performed by inserting an applicator into the anal canal, inflating a balloon to occlude passage of stool and then installing 500-1000 mL of tap water via an irrigation system to fill the rectum and distal colon, followed by evacuation of bowel contents. Participants in the TAI-intervention arm will receive in-person training to learn how to use TAI and will also be given weekly virtual or in-person follow-up appointments for the first 4 weeks to troubleshoot any issues with TAI. Participants will do TAI once per day for 3 months. Each session of TAI takes about 20-60 minutes, depending on the individual's experience and bowel response.

  • LARS mobile application

    Other intervention

    Both arms will receive access to the LARS mobile application, which is a digital self-management tool. The app provides interactive educational content, personalized bowel function diaries, guided video tutorials, and peer testimonials, all designed to enhance engagement, promote self-efficacy, and support long-term self-management. The TAI-intervention arm will also receive access to a TAI Module on the LARS app that will offer comprehensive educational resources, including step-by-step guidance, animations, photographs, and participant videos to reinforce safe and confident use of the TAI system.

Treatment groups

60 Participants
are divided into 2 treatment groups
Group A: Transanal Irrigation (TAI) - intervention armOther 2 interventions
Group B: Continued conservative management - control arm.Other 1 intervention

Trial outcomes

Primary outcomes

1

Patient-Reported Outcomes Measurement Information System (PROMIS)-GI Diarrhea at baseline

PROMIS\_GI Diarrhea with domains covering Frequency, urgency, burden. T-score (mean = 50, SD = 10); higher scores = worse diarrhea

Time frame
Baseline
2

Patient-Reported Outcomes Measurement Information System (PROMIS)-GI Diarrhea at 1 month

PROMIS\_GI Diarrhea with domains covering Frequency, urgency, burden. T-score (mean = 50, SD = 10); higher scores = worse diarrhea

Time frame
1 month post randomization
3

Patient-Reported Outcomes Measurement Information System (PROMIS)-GI Diarrhea at 2 months

PROMIS\_GI Diarrhea with domains covering Frequency, urgency, burden. T-score (mean = 50, SD = 10); higher scores = worse diarrhea

Time frame
2 months post randomization
4

Patient-Reported Outcomes Measurement Information System (PROMIS)-GI Diarrhea at 3 months

PROMIS\_GI Diarrhea with domains covering Frequency, urgency, burden. T-score (mean = 50, SD = 10); higher scores = worse diarrhea

Time frame
3 months post randomization

Secondary outcomes

1

PROMIS Physical Function at baseline

PROMIS\_Physical Function with domains covering Physical capability, daily activity performance.T-score (mean = 50, SD = 10); higher scores = better physical function

Time frame
Baseline
2

PROMIS Physical Function at 1 month

PROMIS\_Physical Function with domains covering Physical capability, daily activity performance.T-score (mean = 50, SD = 10); higher scores = better physical function

Time frame
1 month post randomization
3

PROMIS Physical Function at 2 months

PROMIS\_Physical Function with domains covering Physical capability, daily activity performance. T-score (mean = 50, SD = 10); higher scores = better physical function

Time frame
2 months post randomization
4

PROMIS Physical Function at 3 months

PROMIS\_Physical Function with domains covering Physical capability, daily activity performance.T-score (mean = 50, SD = 10); higher scores = better physical function

Time frame
3 months post randomization

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Case Comprehensive Cancer Center

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: