Ignite Creation Date:
2024-05-06 @ 7:52 PM
Last Modification Date:
2024-10-26 @ 3:15 PM
Study NCT ID:
NCT06162143
Status:
RECRUITING
Last Update Posted:
2024-01-10
First Post:
2023-11-30
Brief Title:
Effect of Gelsectan in the Treatment of Low Anterior Resection Syndrome
Sponsor:
Istituto Clinico Humanitas
Organization:
Istituto Clinico Humanitas
Study Overview
Official Title:
Real World Evaluation of the Effect of Gelsectan in Low Anterior Resection Syndrome Patients a Pilot Prospective Case-series Pilot Study GeLAR
Status:
RECRUITING
Status Verified Date:
2024-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
GeLAR
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
The objective of this study is to provide preliminary data to determine whether the administration of Gelsectan may ameliorate the symptoms of LARS
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None