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

Last updated: January 8, 2024
Sponsor: Istituto Clinico Humanitas
Overall Status: Active - Recruiting

Phase

N/A

Condition

N/A

Treatment

Gelsectan®

Clinical Study ID

NCT06162143
097-2022
  • Ages > 18
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Patients aged more than 18 years old.
  • Patients who underwent low rectal resection for rectal cancer and who closed theileostomy 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 thescreening visit.
  • Presence of a functional, intact anastomosis.
  • Female patients of childbearing potential must agree to use a reliable method ofcontraception.

Exclusion

Exclusion Criteria:

  • Known hypersensitivity to the investigational medicinal product (IMP).
  • Any condition that, in the opinion of the investigator, may interfere with the studyprocedures.
  • Significant anastomotic complications (e.g., strictures, fistula), which may impairthe treatment efficacy.
  • Pregnant or breastfeeding women.
  • Inability to comply with the study procedures.

Study Design

Total Participants: 73
Treatment Group(s): 1
Primary Treatment: Gelsectan®
Phase:
Study Start date:
November 15, 2023
Estimated Completion Date:
November 15, 2025

Study Description

Low Anterior Resection Syndrome (LARS) affects almost 70% of patients after rectal resection for rectal cancer and is characterized by intestinal symptoms including urgency, fractioned defecation, and fecal incontinence. LARS is clinically diagnosed using the LARS score: a score higher than 21 indicates the presence of LARS and a score higher than 30 indicates severe LARS. The treatment opportunities for LARS are limited and failure rates are high. Gelsectan® is a class II device containing xyloglucans, xylo-oligosaccharides, pea proteins, and tannins from grape seeds extract, resulting effective in improving intestinal symptoms in patients with diarrheic Irritable Bowel Syndrome (IBS). Given the symptomatic similarities between LARS and IBS, Gelsectan® may represent a valid first line treatment for LARS patients.

The objective of this study is to provide preliminary data to determine whether the administration of Gelsectan® may ameliorate the symptoms of LARS.

Connect with a study center

  • IRCCS Humanitas Research Hospital

    Rozzano, MI 20089
    Italy

    Active - Recruiting

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