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NCT07219745Not yet recruiting

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

Transanal Irrigation for the Management of Early Low Anterior Resection Syndrome (LARS): A Pilot Randomized Controlled Trial

Source: ClinicalTrials.gov · Last updated 18 Aug 2026

Brief summary (registry, in English)

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.

Status (registry)
Not yet recruiting
Study type
Interventional
Enrollment
60 (estimated)
First submitted
20 Oct 2025
Start date
1 Oct 2026
Primary completion date
30 Nov 2027
Lead sponsor
Case Comprehensive Cancer Center
NCT number
NCT07219745

What you commit to

  • Study type: Interventional
  • Planned participants: 60
  • From 1 Oct 2026 to the primary completion date, 30 Nov 2027
  • 1 site in 1 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.

Prior treatment

  • ongoing chemotherapy or radiotherapy, and

Other

  • 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 anastomotic complication.

Who the study is looking for

  • 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

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Case Comprehensive Cancer Center, Digestive Disease Institute Cleveland Clinic Florida
Coordinator of this site? Confirm its status
WestonUnited StatesUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.