Status:
NOT_YET_RECRUITING
Transanal Irrigation for the Management of Early Low Anterior Resection Syndrome (LARS)
Lead Sponsor:
Case Comprehensive Cancer Center
Conditions:
Colorectal Cancer
Low Anterior Resection Syndrome
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
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 ...
Detailed Description
Colorectal cancer is the third most common cancer in the U.S. with 152,810 new cases estimated for 2024. Rectal cancer comprises one-third of all incident cases, with rising incidence among young indi...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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.
Key Trial Info
Start Date :
November 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 1 2026
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT07219745
Start Date
November 1 2025
End Date
November 1 2026
Last Update
October 22 2025
Active Locations (1)
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1
Case Comprehensive Cancer Center, Digestive Disease Institute Cleveland Clinic Florida
Weston, Florida, United States, 33331