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

Study Overview
=================
Brief 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.

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.

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

Conditions
-----------------
Low Anterior Resection Syndrome

Intervention / Treatment
-----------------
* Device: Gelsectan®


Participation Criteria
=================
Eligibility Criteria
-----------------
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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Gelsectan®<br>Patients in the Gelsectan® cohort will receive one capsule of Gelsectan® twice a day (after lunch and dinner) for 28 days. | Device: Gelsectan®<br>* 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).<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Low Anterior Resection Syndrome (LARS) score | The median LARS score before and after the treatment with Gelsectan® | 28 days after treatment initiation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Air incontinence | The grade of flatus incontinence as measured on Low Anterior Resection Syndrome (LARS) score | 28 days after treatment initiation | 
| Stool incontinence | The grade of stool incontinence as measured on Low Anterior Resection Syndrome (LARS) score | 28 days after treatment initiation | 
| Stool frequency | The grade of stool frequency as measured on Low Anterior Resection Syndrome (LARS) score | 28 days after treatment initiation | 
| Defecation fractioning | The grade of defecation fractioning as measured on Low Anterior Resection Syndrome (LARS) score | 28 days after treatment initiation | 
| Defecation urgency | The grade of defecation urgency as measured on Low Anterior Resection Syndrome (LARS) score | 28 days after treatment initiation | 
| Memorial Sloan Kettering Cancer Center Bowel Function Instrument (MSKCC-BFI) score | The median MSKCC-BFI score before and after the treatment with Gelsectan® | 28 days after treatment initiation | 
| Major Low Anterior Resection Syndrome (LARS) proportion | The difference in the proportion of patients with a severe LARS score before and after the treatment | 28 days after treatment initiation | 
| 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Low Anterior Resection Syndrome, Rectal cancer, xyloglucans, xylo-oligosaccharides