Using Gelsectan® to treat Low Anterior Resection Syndrome
Real World Evaluation of the Effect of Gelsectan® in Low Anterior Resection Syndrome Patients: a Pilot Prospective Case-series Pilot Study (GeLAR)
Istituto Clinico Humanitas · NCT06162143
This study is testing if Gelsectan® can help people who have Low Anterior Resection Syndrome feel better after surgery for rectal cancer.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 73 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Istituto Clinico Humanitas (other) |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Rozzano, MI) |
| Trial ID | NCT06162143 on ClinicalTrials.gov |
What this trial studies
This observational study aims to evaluate the efficacy of Gelsectan®, a class II medical device, in improving symptoms of Low Anterior Resection Syndrome (LARS) in patients who have undergone rectal resection for rectal cancer. LARS affects a significant number of patients post-surgery, leading to symptoms such as urgency and fecal incontinence. The study will assess patients with a LARS score of 21 or higher, indicating the presence of the syndrome, and will provide preliminary data on whether Gelsectan® can alleviate these symptoms. The treatment is based on the similarities between LARS and Irritable Bowel Syndrome, where Gelsectan® has shown effectiveness.
Who should consider this trial
Good fit: Ideal candidates are adults over 18 who have undergone low rectal resection for rectal cancer and exhibit symptoms of LARS.
Not a fit: Patients with known hypersensitivity to Gelsectan® or significant anastomotic complications may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly improve the quality of life for patients suffering from LARS.
How similar studies have performed: While Gelsectan® has been effective in treating Irritable Bowel Syndrome, its application for LARS is novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients aged more than 18 years old. * Patients who underwent low rectal resection for rectal cancer and who closed the ileostomy at least three months before the screening visit. * Patients with a LARS score ≥21 and/or clinically relevant symptoms of urgency, increased stool frequency, or fecal incontinence. * Patients indicated to treatment with Gelsectan® according to the clinical judgment. * Oncological chemotherapy or radiotherapy completed at least four weeks before the screening visit. * Presence of a functional, intact anastomosis. * Female patients of childbearing potential must agree to use a reliable method of contraception. Exclusion Criteria: * Known hypersensitivity to the investigational medicinal product (IMP). * Any condition that, in the opinion of the investigator, may interfere with the study procedures. * Significant anastomotic complications (e.g., strictures, fistula), which may impair the treatment efficacy. * Pregnant or breastfeeding women. * Inability to comply with the study procedures.
Where this trial is running
Rozzano, MI
- IRCCS Humanitas Research Hospital — Rozzano, MI, Italy (RECRUITING)
Study contacts
- Principal investigator: Antonino Spinelli, MD,PhD — Humanitas Research Hospital IRCCS, Rozzano-Milan
- Study coordinator: Antonino Spinelli, MD, PhD
- Email: antonino.spinelli@hunimed.eu
- Phone: 0282247776
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.
Conditions: Low Anterior Resection Syndrome, Rectal cancer, xyloglucans, xylo-oligosaccharides