Symptoms and General Pathology

All Conditions

Digestive System Diseases

Syndrome

Low Anterior Resection Syndrome

Colonic Diseases

Intestinal Diseases

Gastrointestinal Diseases

Rectal Diseases

Postoperative Complications

Antineoplastic Agents

All Drugs and Chemicals

Central Nervous System Depressants

Herbal and Botanical

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Grape Seed Extract

Benzocaine

Grape

Tannic Acid

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

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).

Gelsectan®

Antonino Spinelli, MD, PhD

Caterina Foppa, MD,PhD

Annalisa Maroli, PhD

Stefano De Zanet

Antonino Spinelli, MD,PhD

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.

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.

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

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

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.

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).

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).

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).

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).

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).

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).

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.

The difference in the proportion of patients reporting diarrheic feces before and after the treatment as evaluated by the Bristol scale

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Effect of Gelsectan® in the Treatment of Low Anterior Resection Syndrome	NCT06162143	Low Anterior Re...	Gelsectan®	18 Years -	Istituto Clinico Humanitas
Effect of Gelsectan® in the Treatment of Low Anterior Resection Syndrome	NCT06162143	Low Anterior Re...	Gelsectan®	18 Years -	Istituto Clinico Humanitas

Spots Global Cancer Trial Database for xyloglucans

Every month we try and update this database with for xyloglucans cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for xyloglucans

Every month we try and update this database with for xyloglucans cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for xyloglucans cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.