Effect of Gelsectan® in the Treatment of Low Anterior Resection Syndrome

Launched by ISTITUTO CLINICO HUMANITAS · Nov 30, 2023

Keywords

ClinConnect Summary

This clinical trial is studying a treatment called Gelsectan® for people suffering from Low Anterior Resection Syndrome (LARS). LARS is a condition that can occur after surgery for rectal cancer, causing issues like urgency to use the bathroom, frequent stools, and accidental leakage. The trial aims to see if Gelsectan®, which is sometimes used for Irritable Bowel Syndrome, can help improve these symptoms for patients who had surgery to remove part of their rectum.

To participate in this trial, you need to be over 18 years old and have had a low rectal resection for rectal cancer with an ileostomy closure done at least three months ago. You should also have a LARS score of 21 or higher, indicating significant symptoms. Participants will be monitored to see how well Gelsectan® works for them, and it's important to know that women who can become pregnant need to use reliable birth control during the study. If you're interested and think you might qualify, this could be an opportunity to help improve your symptoms while contributing to important research.

Gender

ALL

Eligibility 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.