Status:
RECRUITING
Effect of Gelsectan® in the Treatment of Low Anterior Resection Syndrome
Lead Sponsor:
Istituto Clinico Humanitas
Conditions:
Low Anterior Resection Syndrome
Eligibility:
All Genders
18+ years
Brief 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 us...
Detailed 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...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
November 15 2023
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
November 15 2025
Estimated Enrollment :
73 Patients enrolled
Trial Details
Trial ID
NCT06162143
Start Date
November 15 2023
End Date
November 15 2025
Last Update
January 10 2024
Active Locations (1)
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1
IRCCS Humanitas Research Hospital
Rozzano, MI, Italy, 20089