Transanal irrigation for improving bowel function after rectal surgery
Transanal Irrigation - Best Treatment Possibility for Low Anterior Resection Syndrome? Multicenter, Randomized Clinical Trial
This study is testing if a method called transanal irrigation can help people with bowel problems after rectal surgery feel better and improve their quality of life.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | National Cancer Center Affiliate of Vilnius University Hospital Santaros Klinikos Academic / other |
| Locations | 1 site (Vilnius) |
| Trial ID | NCT05920681 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the effectiveness of transanal irrigation in improving bowel function and quality of life for patients suffering from Low Anterior Resection Syndrome (LARS) following rectal resection. Participants will be assessed for their defecation problems and overall quality of life through various questionnaires, including the LARS score and quality of life measures. The study will compare the outcomes of transanal irrigation against the best supportive care over a 12-month period, with assessments conducted every three months to track improvements.
Who should consider this trial
Good fit: Ideal candidates are adults who have undergone low anterior resection and have developed major LARS symptoms.
Not a fit: Patients with tumor recurrence, inflammatory bowel disease, or those unable to perform irrigation may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly enhance bowel function and quality of life for patients suffering from LARS.
How similar studies have performed: While there have been no definitive randomized trials on this specific treatment for LARS, the approach of using transanal irrigation has shown promise in related conditions.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Subject is an adult (≥ 18 years); * Agrees to participate in a study; * A low anterior resection (robotic, laparoscopic or open) was performed (anastomosis up to 5-7 cm from the anocutaneous line when assessed with a finger or endo(recto)scope); * \>12 months have passed since the operation or the closure of the ileostomy (if formed); * No anastomotic leak or stenosis (assessed clinically, during examination, and/or proctogram); * LARS \>30 points (major LARS). Exclusion Criteria: * Tumor recurrence/progression * Pregnancy * Diagnosed with inflammatory bowel disease (ICD codes K50-59). * Side-to-end anastomosis * Palliative care * Will not be able to perform irrigation
Where this trial is running
Vilnius
- National Cancer Institute — Vilnius, Lithuania (Recruiting)
Study contacts
- Study coordinator: Audrius Dulskas, PhD
- Email: audrius.dulskas@nvi.lt
- Phone: (85) 219 0947
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.