Clinical trial · Observational
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)
NCT06162143CI-TRIAL-00072891GeLARunknownClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Low Anterior Resection Syndrome | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Gelsectan® | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Gelsectan®
- description
- Patients in the Gelsectan® cohort will receive one capsule of Gelsectan® twice a day (after lunch and dinner) for 28 days.
- interventionNames
- Device: Gelsectan®
Primary outcomes (1)
- measure
- Low Anterior Resection Syndrome (LARS) score
- timeFrame
- 28 days after treatment initiation
- description
- 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.
Secondary outcomes (8)
- measure
- Air incontinence
- timeFrame
- 28 days after treatment initiation
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.