Effect of Gelsectan® in the Treatment of Low Anterior Resection Syndrome (GeLAR)

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.

Study Overview

• Status: Recruiting
• Conditions: Low Anterior Resection Syndrome
• Intervention / Treatment: Device: Gelsectan®

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 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.

• Study Type: Observational
• Enrollment (Estimated): 73

Contacts and Locations

• Study Contact: Name: Antonino Spinelli, MD, PhD; Phone Number: +39 0282247776; Email: antonino.spinelli@hunimed.eu
• Study Contact Backup: Name: Caterina Foppa, MD,PhD; Phone Number: +39 0282247776; Email: caterina.foppa@hunimed.eu

Study Locations

• Italy
  • MI
    • Rozzano, MI, Italy, 20089
      • Recruiting
      • IRCCS Humanitas Research Hospital
      • Contact: Annalisa Maroli, PhD; Phone Number: +390282247776; Email: annalisa.maroli@humanitas.it
      • Contact: Stefano De Zanet; Phone Number: +390282244623; Email: stefano.dezanet@humanitas.it

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

The study population will include adult rectal cancer patients who underwent low rectal resection and ileostomy closure.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Gelsectan®; Patients in the Gelsectan® cohort will receive one capsule of Gelsectan® twice a day (after lunch and dinner) for 28 days.	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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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
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
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
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

Collaborators and Investigators

• Sponsor: Istituto Clinico Humanitas
• Investigators: Principal Investigator: Antonino Spinelli, MD,PhD, IRCCS Humanitas Research Hospital

Study record dates

Study Major Dates

• Study Start (Actual): November 15, 2023
• Primary Completion (Estimated): June 15, 2025
• Study Completion (Estimated): November 15, 2025

Study Registration Dates

• First Submitted: November 30, 2023
• First Submitted That Met QC Criteria: November 30, 2023
• First Posted (Actual): December 8, 2023

Study Record Updates

• Last Update Posted (Actual): January 10, 2024
• Last Update Submitted That Met QC Criteria: January 8, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Keywords: Rectal cancer; Low Anterior Resection Syndrome; xyloglucans; xylo-oligosaccharides
• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Postoperative Complications; Disease; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases; Syndrome; Low Anterior Resection Syndrome
• Other Study ID Numbers: 097-2022

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No