Real World Evaluation of the Effect of Gelsectan® in Low Anterior Resection Syndrome Patients: a Pilot Prospective Case-series Pilot Study (GeLAR)
Low Anterior Resection Syndrome (LARS) is an intestinal disorder affecting patients undergoing rectal resection for rectal cancer. A possible therapeutic option may be Gelsectan®, a class II device used in Irritable Bowel Syndrome (IBS). The aim of this study is to evaluate the efficacy of Gelsectan® in improving the symptoms of LARS.
• 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.