Clinical Trials Logo

Clinical 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). The aim of this study is to evaluate the efficacy of Gelsectan® in improving the symptoms of LARS.


Clinical Trial 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


Related Conditions & MeSH terms


NCT number NCT06162143
Study type Observational
Source Istituto Clinico Humanitas
Contact Antonino Spinelli, MD, PhD
Phone 0282247776
Email antonino.spinelli@hunimed.eu
Status Recruiting
Phase
Start date November 15, 2023
Completion date November 15, 2025

See also
  Status Clinical Trial Phase
Recruiting NCT04087421 - Comparison of Transanal Irrigation and Glycerol Suppositories in Treatment of Low Anterior Resection Syndrome Phase 3
Recruiting NCT04023448 - The Effect of Different Reconstruction Methods on Anterior Resection Syndrome N/A
Recruiting NCT04040842 - International Low Anterior Resection Score Evaluation
Recruiting NCT03828318 - Impact of a Patient-Centered Program for Low Anterior Resection Syndrome A Multicenter Randomized Controlled Trial N/A
Not yet recruiting NCT06424522 - A Bowel Management Program (Retrograde Rectal Enema) for the Treatment of Low Anterior Resection Syndrome in Rectal Cancer Patients Early Phase 1
Completed NCT05605600 - Translation of the International Consensus Definition of LARS Into a Bowl Dysfunction Severity Scoring Tool (New LARS Score)
Completed NCT05016583 - Paula Method of Exercises in Patients With LARS Syndrome N/A
Active, not recruiting NCT05042700 - The Effect of Melatonin in Patients With Low Anterior Resection Syndrome Phase 2
Recruiting NCT04612569 - Feasibility and Impact of a Prehabilitation and Rehabilitation Program for the Continuity of Care in Severe Low Anterior Resection Syndrome.
Completed NCT04896879 - Experiences and Needs of Patients, Their Informal Caregiver and Healthcare Professionals Regarding LARS
Withdrawn NCT03257332 - Determining Early Development of Faecal Incontinence and Anorectal Muscle Function After Surgery for Rectal Cancer.
Completed NCT03916549 - Acupuncture in Low Anterior Resection Syndrome Treatment Phase 1
Completed NCT05020132 - Bowel Dysfunction After Rectal Cancer Treatment
Completed NCT03598231 - Effectiveness of Sacral Neuromodulation in Low Anterior Resection Syndrome N/A
Recruiting NCT05420870 - Effect of Exercise on Bowel Function in Colorectal Cancer Survivors N/A
Active, not recruiting NCT05319054 - Pathway of Low Anterior Resection Syndrome Relief After Surgery: a Feasibility Study N/A
Completed NCT01589471 - The Value of Botox-A for Management of Low Anterior Resection Syndrome Phase 2
Completed NCT03215017 - Effect of Treatment of Low Anterior Resection Syndrome After Rectal Cancer Surgery N/A
Completed NCT05129215 - Development and Validation of The Post-RT LARS Prediction Model (PORTLARS)
Recruiting NCT05682157 - Paula Method of Exercises in Patients With LARS Syndrome:Randomized Controlled Trial N/A