Low Anterior Resection SyndromeGeLARNCT06162143
Effect of Gelsectan® in the Treatment of Low Anterior Resection Syndrome
An observational study of Low Anterior Resection Syndrome, run by Istituto Clinico Humanitas at 1 site in Italy.
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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Low Anterior Resection Syndrome
- What is being tested?
- Gelsectan®
- Type of treatment
- Pill or oral medicine, Medical device
- How many people
- 73 participants
- Where
- 1 siteItaly
- Study dates
- 15 Nov 2023to 15 Nov 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study population will include adult rectal cancer patients who underwent low rectal resection and ileostomy closure.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
IRCCS Humanitas Research Hospital
Rozzano, MI, 20089
Annalisa Maroli, PhD, +390282247776, annalisa.maroli@humanitas.it
Stefano De Zanet, +390282244623, stefano.dezanet@humanitas.it
About this study
Official title: 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.
Read the 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.
- Conditions
- Low Anterior Resection Syndrome
- Being tested
- Gelsectan®
- Keywords
- Low Anterior Resection Syndrome, Rectal cancer, xyloglucans, xylo-oligosaccharides
- Medical subject headings
- Low Anterior Resection Syndrome, Rectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gelsectan®Device
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).
| Study group | Role | What they receive |
|---|---|---|
| Gelsectan® | Patients in the Gelsectan® cohort will receive one capsule of Gelsectan® twice a day (after lunch and dinner) for 28 days. Receives: Device: Gelsectan® |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 28 days after treatment initiation
Secondary outcomes (8)
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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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.
Measured: 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
Measured: 28 days after treatment initiation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2023
- Study start15 Nov 2023
- Primary completion15 Jun 2025 (estimated)
- Study completion15 Nov 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Low Anterior Resection SyndromeStudies of the same condition, open and under way.
- More trials run by Istituto Clinico HumanitasThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 73 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Istituto Clinico Humanitas
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Antonino Spinelli, MD,PhD, Principal investigator, Humanitas Research Hospital IRCCS, Rozzano-Milan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06162143
- Sponsor's protocol ID
- 097-2022
- Acronym
- GeLAR
- Status last verified
- Jan 2024
- First submitted
- 30 Nov 2023
- Last updated
- 10 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Real World Evaluation of the Effect of Gelsectan® in Low Anterior Resection Syndrome Patients: a Pilot Prospective Case-series Pilot Study (GeLAR)
- ClinicalTrials.gov ID
- NCT06162143
- Acronym / sponsor ID
- GeLAR / 097-2022
- Conditions
- Low Anterior Resection Syndrome
- Keywords
- Low Anterior Resection Syndrome, Rectal cancer, xyloglucans, xylo-oligosaccharides
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 73 participants (estimated)
- Lead sponsor
- Istituto Clinico HumanitasUniversity, hospital or other
- Study start
- 15 Nov 2023 (actual)
- Primary completion
- 15 Jun 2025 (estimated)
- Study completion
- 15 Nov 2025 (estimated)
- First posted
- 8 Dec 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Gelsectan® | – | Device: Gelsectan®Patients in the Gelsectan® cohort will receive one capsule of Gelsectan® twice a day (after lunch and dinner) for 28 days. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population will include adult rectal cancer patients who underwent low rectal resection and ileostomy closure.
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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). | Device | Gelsectan® |
Primary outcome
Low Anterior Resection Syndrome (LARS) score
Time frame: 28 days after treatment initiation
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.
8 secondary outcomes
Air incontinence
Time frame: 28 days after treatment initiation
Stool incontinence
Time frame: 28 days after treatment initiation
Stool frequency
Time frame: 28 days after treatment initiation
Defecation fractioning
Time frame: 28 days after treatment initiation
Defecation urgency
Time frame: 28 days after treatment initiation
Memorial Sloan Kettering Cancer Center Bowel Function Instrument (MSKCC-BFI) score
Time frame: 28 days after treatment initiation
Major Low Anterior Resection Syndrome (LARS) proportion
Time frame: 28 days after treatment initiation
Diarrhea
Time frame: 28 days after treatment initiation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jan 2024.
- Individual participant dataSharing planned: No
Related trials for Low Anterior Resection Syndrome
Not yet recruiting
Efficacy of a Novel High Intensive Percutaneous Tibial Nerve Stimulation on Faecal Incontinence in Patients With Low Anterior Resection Cancer Syndrome After Rectal Cancer Surgery
Faecal Incontinence With Faecal Urgency, Rectal Cancer
Recruiting
A Bowel Management Program (Retrograde Rectal Enema) for the Treatment of Low Anterior Resection Syndrome in Rectal Cancer Patients
Low Anterior Resection Syndrome, Rectal Carcinoma
Not yet recruiting
Transanal Irrigation for the Management of Early Low Anterior Resection Syndrome (LARS)
Colorectal Cancer, Low Anterior Resection Syndrome
Not yet recruiting
Early Implementation of Sacral Neuromodulation in Patients With Low Anterior Resection Syndrome.
Low Anterior Resection Syndrome (LARS)
Recruiting
Aerobic Exercise and Guided Imagery in Low Anterior Resection Syndrome
Rectal Cancer, Fecal Incontinence and Constipation
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Antonino Spinelli, MD,PhD principal investigator
Humanitas Research Hospital IRCCS, Rozzano-Milan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Low Anterior Resection Syndrome, run by Istituto Clinico Humanitas at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 10 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Antonino Spinelli, MD, PhD (0282247776 ext. +39, antonino.spinelli@hunimed.eu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Low Anterior Resection Syndrome (LARS) score (time frame: 28 days after treatment initiation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jan 2024.