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
Who can join
As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.
- Age
- 18 Years and older
- Sex
- All sexes
- Healthy volunteers
- Not accepted
- Compensation
- Not stated
Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.
What to expect
No one can promise a trial will help you personally — that is what the research is trying to find out.
What participation involves
- Procedures mentioned: Pills
Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.
Show the study's own words
- "The LARS-TAI App is accessible on any device with internet access or cellular data, including smart phones, tablets, and computers."
- Compensation
- Not stated
- Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
- Participants are monitored closely by the research team throughout the study.
- Some participants may receive access to an investigational treatment, which is still being studied.
- Your participation helps researchers learn whether this approach could help future patients.
About this study
In plain language
This small study tests transanal irrigation, which uses water through the anus to help empty the bowel, after low anterior resection (LAR), surgery on the rectum. It is for adults in the first 12 months after LAR who plan to have their temporary bowel opening closed. The study will check whether this treatment improves bowel control and quality of life, and whether a larger study is possible.
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.
Compensation is read from the study's own description and may be missing — always confirm with the study team.
Eligibility
Who can join
- You are 18 or older.
- You had LAR surgery for any reason, using open, keyhole, robotic, or through-the-anus surgery.
- During surgery, you had a temporary opening made in your belly to move waste from your small bowel into a bag (loop ileostomy).
- Tests show that the place where your bowel was joined has healed. These include a flexible scope exam and either a CT scan with liquid placed in the rectum or a special enema test.
- You plan to have surgery to close the temporary bowel opening.
- You are within the first 12 months after LAR surgery.
Who can't join
- You cannot understand English or Spanish, or cannot give informed consent, meaning you understand and agree to join. Spanish study papers are planned after the English papers are approved.
- You are currently getting chemotherapy or radiation treatment.
- You still have a problem where your bowel was joined during surgery.
Simplified for readability. The official criteria below are what the study team uses.
Official eligibility criteria
Inclusion Criteria: 1. 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, 2. have confirmed anastomotic healing demonstrated by flexible sigmoidoscopy and CT scan with rectally-administered water soluble contrast or gastrograffin enema, 3. are planned for an ileostomy closure operation, and 4. are in the first 12 months post-LAR operation Exclusion Criteria: 1. 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), 2. ongoing chemotherapy or radiotherapy, and 3. ongoing anastomotic complication.
Study sites (1)
FL
- Case Comprehensive Cancer Center, Digestive Disease Institute Cleveland Clinic Florida · Weston, FL 33331Marylise Boutros, MD · Study contactMore trials in Weston