Low Anterior Resection Syndrome Clinical Trial
— GeLAROfficial title:
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.
Status | Recruiting |
Enrollment | 73 |
Est. completion date | November 15, 2025 |
Est. primary completion date | June 15, 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
Italy | IRCCS Humanitas Research Hospital | Rozzano | MI |
Lead Sponsor | Collaborator |
---|---|
Istituto Clinico Humanitas |
Italy,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Low Anterior Resection Syndrome (LARS) score | The median Low Anterior Resection Syndrome (LARS) score before and after the treatment with Gelsectan®. The Low Anterior Resection Syndrome (LARS) score ranges from 0 to 42, where 0 represent no LARS symtpoms and 42 represent major LARS symtpoms. | 28 days after treatment initiation | |
Secondary | Air incontinence | The grade of flatus incontinence as measured on Low Anterior Resection Syndrome (LARS) score. The air incontinence domain ranges from 0 (no symtpoms) to 7 (severe symtpoms). | 28 days after treatment initiation | |
Secondary | Stool incontinence | The grade of stool incontinence as measured on Low Anterior Resection Syndrome (LARS) score. The stool incontinence domain range from 0 (no symtpoms) to 3 (severe symptoms). | 28 days after treatment initiation | |
Secondary | Stool frequency | The grade of stool frequency as measured on Low Anterior Resection Syndrome (LARS) score. The stool frequency domain ranges from 0 (regular frequency) to 5 (irregular frequency). | 28 days after treatment initiation | |
Secondary | Defecation fractioning | The grade of defecation fractioning as measured on Low Anterior Resection Syndrome (LARS) score. The defecation fractioning domain ranges from 0 (no symptoms) to 11 (severe symptoms). | 28 days after treatment initiation | |
Secondary | Defecation urgency | The grade of defecation urgency as measured on Low Anterior Resection Syndrome (LARS) score. The defecation urgency domain ranges from 0 (no symptoms) to 16 (severe symptoms). | 28 days after treatment initiation | |
Secondary | Memorial Sloan Kettering Cancer Center Bowel Function Instrument (MSKCC-BFI) score | The median Memorial Sloan Kettering Cancer Center Bowel Function Instrument (MSKCC-BFI) score before and after the treatment with Gelsectan®. The Memorial Sloan Kettering Cancer Center Bowel Function Instrument (MSKCC-BFI) score ranges from 0 (normal defecatory condition) to 68 (severe defecatory symptoms). | 28 days after treatment initiation | |
Secondary | Major Low Anterior Resection Syndrome (LARS) proportion | The difference in the proportion of patients with a severe Low Anterior Resection Syndrome score before and after the treatment, as defined by a Low Anterior Resection Syndrome (LARS) score equal to or higher than 30. | 28 days after treatment initiation | |
Secondary | Diarrhea | The difference in the proportion of patients reporting diarrheic feces before and after the treatment as evaluated by the Bristol scale | 28 days after treatment initiation |
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