Transanal Irrigation for the Management of Early Low Anterior Resection Syndrome (LARS)
Starting soon · Not applicable
Conditions studied: Colorectal Cancer, Low Anterior Resection Syndrome
In brief
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.
Key facts
- Study ID
- NCT07219745
- Run by
- Case Comprehensive Cancer Center
- People needed
- 60
- Starts
- 2026-10-01
- Expected to finish
- 2027-11-01
- Last updated by the study team
- 2026-06-25
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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.
Where it is running
- Case Comprehensive Cancer Center, Digestive Disease Institute Cleveland Clinic Florida — Weston, Florida, United States
Full record on ClinicalTrials.gov
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