Clinical trial NCT06162143: Effect of Gelsectan® in the Treatment of Low Anterior Resection Syndrome
Official title: Real World Evaluation of the Effect of Gelsectan® in Low Anterior Resection Syndrome Patients: a Pilot Prospective Case-series Pilot Study (GeLAR)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Low Anterior Resection Syndrome
Keywords: Low Anterior Resection Syndrome
Rectal cancer
xyloglucans
xylo-oligosaccharides
Lead sponsor: Istituto Clinico Humanitas
Sponsor class: OTHER
First posted: 2023-12-08
Enrollment: 73
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population will include adult rectal cancer patients who underwent low rectal resection and ileostomy closure.

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.

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.

Primary outcomes:
measure: Low Anterior Resection Syndrome (LARS) score
timeFrame: 28 days after treatment initiation
Secondary outcomes:
measure: Air incontinence
timeFrame: 28 days after treatment initiation
measure: Stool incontinence
timeFrame: 28 days after treatment initiation
measure: Stool frequency
timeFrame: 28 days after treatment initiation
measure: Defecation fractioning
timeFrame: 28 days after treatment initiation
measure: Defecation urgency
timeFrame: 28 days after treatment initiation
measure: Memorial Sloan Kettering Cancer Center Bowel Function Instrument (MSKCC-BFI) score
timeFrame: 28 days after treatment initiation
measure: Major Low Anterior Resection Syndrome (LARS) proportion
timeFrame: 28 days after treatment initiation
measure: Diarrhea
timeFrame: 28 days after treatment initiation
Other outcomes:
Locations:
city: Rozzano
country: Italy
facility: IRCCS Humanitas Research Hospital
state: MI
Study officials:
affiliation: Humanitas Research Hospital IRCCS, Rozzano-Milan
name: Antonino Spinelli, MD,PhD
role: PRINCIPAL_INVESTIGATOR
References: