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NCT07219745

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

Not Yet Recruiting
NAAges 18+InterventionalSupportive care
Case Comprehensive Cancer Center
~60 participants
Updated 2026-08-18 on ClinicalTrials.gov
What's tested:Peristeen Plus Irrigation kitLARS mobile application

At a glance

Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Patient-Reported Outcomes Measurement Information System (PROMIS)-GI Diarrhea at baseline
Measured over Baseline
+8 more outcomes measured

Conditions

Colorectal Cancer
Low Anterior Resection Syndrome

Explore related trials

Colorectal CarcinomaLow Anterior Resection Syndrome

Where it's being run

1 sites across 1 states
Florida1

Who to contact

Marylise Boutros, MD
[email protected]
954-659-5278
Email the study team

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What this trial measures

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

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

  • Patient-Reported Outcomes Measurement Information System (PROMIS)-GI Diarrhea at 1 month1 month post randomization

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

  • Patient-Reported Outcomes Measurement Information System (PROMIS)-GI Diarrhea at 2 months2 months post randomization

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

  • Patient-Reported Outcomes Measurement Information System (PROMIS)-GI Diarrhea at 3 months3 months post randomization

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

  • PROMIS-GI Fecal Incontinence at baselineBaseline

    PROMIS\_GI Fecal Incontinence with domains covering Leakage, control, impact . T-score (mean = 50, SD = 10); higher scores = worse incontinence

  • PROMIS-GI Fecal Incontinence at 1 month1 month post randomization

    PROMIS\_GI Fecal Incontinence with domains covering Leakage, control, impact . T-score (mean = 50, SD = 10); higher scores = worse incontinence

  • PROMIS-GI Fecal Incontinence at 2 months2 months post randomization

    PROMIS\_GI Fecal Incontinence with domains covering Leakage, control, impact . T-score (mean = 50, SD = 10); higher scores = worse incontinence

  • PROMIS-GI Fecal Incontinence at 3 months3 months post randomization

    PROMIS\_GI Fecal Incontinence with domains covering Leakage, control, impact . T-score (mean = 50, SD = 10); higher scores = worse incontinence

  • Average monthly randomization rate3 months post ileostomy

    Participants who report a LARS Score of ≥20-the threshold for moderate-to-severe LARS-will meet criteria for randomization. Score range: 0-42 (higher scores = more severe LARS; 0-20 = no LARS, 21-29 = minor, 30-42 = major)