Comparing high-volume and low-volume transanal irrigation for treating Low Anterior Resection Syndrome
High-volume and Low-volume Water Transanal Irrigation for the Management of Low Anterior Resection Syndrome. A Crossover Randomized Controlled Clinical Trial.
This study is testing whether using a larger amount of water for transanal irrigation helps people with Low Anterior Resection Syndrome feel better compared to using a smaller amount after their rectal cancer surgery.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Hospital Universitari de Bellvitge Academic / other |
| Locations | 2 sites (Hospitalet de Llobregat, Barcelona and 1 other locations) |
| Trial ID | NCT05245331 on ClinicalTrials.gov |
What this trial studies
This study investigates the effectiveness of high-volume transanal irrigation using the Peristeen Plus® system compared to low-volume irrigation with a standard 250ml water enema for patients suffering from Low Anterior Resection Syndrome (LARS) after rectal cancer surgery. It is a crossover randomized controlled trial that aims to assess the impact of these two irrigation methods on LARS symptoms and overall quality of life. The primary outcome measured will be the reduction in LARS scores after two months of treatment, providing insights into the optimal irrigation volume and technique for managing this condition.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 and older who have undergone low anterior resection for rectal cancer and experience major LARS symptoms.
Not a fit: Patients with specific surgical histories, such as those with anastomotic complications or previous use of transanal irrigation systems, may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could significantly improve the quality of life for patients suffering from LARS by identifying a more effective irrigation method.
How similar studies have performed: While transanal irrigation has shown promise in improving LARS symptoms, this specific comparison of high-volume versus low-volume methods is novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Personal history of LAR or ultra-LAR with total mesorectal excision (TME) and sphincter preservation with stapled or manual end to end anastomosis for primary rectal cancer. * Major LARS (score 30-42). * At least 1 year follow-up after LAR or ultra-LAR or temporary stoma closure. * Anastomotic integrity demonstrated by endoscopic, radiologic or clinical examination. * Eastern Cooperative Oncology Group (ECOG) performance status (PS) between 0-2. * Age≥ 18 years Exclusion Criteria: * Side to end mechanical anastomosis or J-pouch colorectal anastomosis * Partial or total intersphincteric resection. * Personal history of anastomotic dehiscence, chronic pelvic sepsis, anastomotic sinus, anastomotic stricture or other any other anastomotic complications. * Persona history of other colorectal, proctologic or pelvis surgery or disease. * Personal history of bariatric surgery. * Functioning sacral neurostimulator carriers. * Previous use of transanal irrigation systems for LARS treatment * Presence of an ostomy. * Local or distant rectal cancer recurrence and/or any other active neoplastic disease. * Altered cognitive status. * Pregnancy and age \< 18 years * Any other diseases that may alter results of the study. * Refusal to sign the informed consent.
Where this trial is running
Hospitalet de Llobregat, Barcelona and 1 other locations
- Hospital Universitari de Bellvitge — Hospitalet de Llobregat, Barcelona, Spain (Recruiting)
- Bellvitge University Hospital — Barcelona, Spain (Recruiting)
Study contacts
- Principal investigator: Loris Trenti, PhD
- Study coordinator: Loris Trenti, PhD
- Email: loris.trenti@bellvitgehospital.cat
- Phone: +34 932607500
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.