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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06162143
Other study ID # 097-2022
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date November 15, 2023
Est. completion date November 15, 2025

Study information

Verified date January 2024
Source Istituto Clinico Humanitas
Contact Antonino Spinelli, MD, PhD
Phone 0282247776
Email antonino.spinelli@hunimed.eu
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


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.


Recruitment information / eligibility

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.

Study Design


Related Conditions & MeSH terms


Intervention

Device:
Gelsectan®
Gelsectan® is a CE-marked class II device containing xyloglucans, xylo-oligosaccharides, pea proteins, and tannins from grape seeds extract, already used in Irritable Bowel Syndrome (IBS).

Locations

Country Name City State
Italy IRCCS Humanitas Research Hospital Rozzano MI

Sponsors (1)

Lead Sponsor Collaborator
Istituto Clinico Humanitas

Country where clinical trial is conducted

Italy, 

Outcome

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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