NCT06162143

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
73

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Nov 2023

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 15, 2023

Completed
15 days until next milestone

First Submitted

Initial submission to the registry

November 30, 2023

Completed
8 days until next milestone

First Posted

Study publicly available on registry

December 8, 2023

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 15, 2025

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 15, 2025

Completed
Last Updated

January 10, 2024

Status Verified

January 1, 2024

Enrollment Period

1.6 years

First QC Date

November 30, 2023

Last Update Submit

January 8, 2024

Conditions

Low Anterior Resection Syndrome

Keywords

Low Anterior Resection SyndromeRectal cancerxyloglucansxylo-oligosaccharides

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (8)

  • Air incontinence

    28 days after treatment initiation

  • Stool incontinence

    28 days after treatment initiation

  • Stool frequency

    28 days after treatment initiation

  • Defecation fractioning

    28 days after treatment initiation

  • Defecation urgency

    28 days after treatment initiation

  • +3 more secondary outcomes

Study Arms (1)

Gelsectan®

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

Device: Gelsectan®

Interventions

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).

Gelsectan®

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

IRCCS Humanitas Research Hospital

Rozzano, MI, 20089, Italy

RECRUITING

MeSH Terms

Conditions

Low Anterior Resection SyndromeRectal Neoplasms

Condition Hierarchy (Ancestors)

Colonic DiseasesIntestinal DiseasesGastrointestinal DiseasesDigestive System DiseasesRectal DiseasesPostoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsColorectal NeoplasmsIntestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasms

Study Officials

  • Antonino Spinelli, MD,PhD

    Humanitas Research Hospital IRCCS, Rozzano-Milan

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Antonino Spinelli, MD, PhD

CONTACT

0282247776antonino.spinelli@hunimed.eu

Caterina Foppa, MD,PhD

CONTACT

0282247776caterina.foppa@hunimed.eu

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 30, 2023

First Posted

December 8, 2023

Study Start

November 15, 2023

Primary Completion

June 15, 2025

Study Completion

November 15, 2025

Last Updated

January 10, 2024

Record last verified: 2024-01

Data Sharing

IPD Sharing
Will not share

Locations

IT(1)