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

Low Anterior Resection Syndrome Clinical Trial

— GeLAR  

Official title:

Real World Evaluation of the Effect of Gelsectan® in Low Anterior Resection Syndrome Patients: a Pilot Prospective Case-series Pilot Study (GeLAR)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06162143
• Other study ID #: 097-2022
• Status: Recruiting
• 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
• 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.

Related Conditions & MeSH terms

• Low Anterior Resection Syndrome
• Syndrome

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