Transanal Irrigation for the Management of Early Low Anterior Resection Syndrome (LARS)
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
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
Treatments tested in this trial
- Peristeen Plus Irrigation kit
- LARS mobile application
Treatment groups
60 Participants
are divided into 2 treatment groupsLocations
1Case Comprehensive Cancer Center, Digestive Disease Institute Cleveland Clinic Florida33331, WestonFlorida, United States
Sponsors and collaborators
Case Comprehensive Cancer Center
Lead sponsor
Source ClinicalTrials.gov