Ignite Creation Date:
2024-06-16 @ 11:47 AM
Last Modification Date:
2024-10-26 @ 3:30 PM
Study NCT ID:
NCT06424522
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-06-03
First Post:
2024-05-16
Brief Title:
A Bowel Management Program Retrograde Rectal Enema for the Treatment of Low Anterior Resection Syndrome in Rectal Cancer Patients
Sponsor:
Ohio State University Comprehensive Cancer Center
Organization:
Ohio State University Comprehensive Cancer Center
Study Overview
Official Title:
Low Anterior Resection Syndrome Retrograde Enema Program vs Medical Management
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-05
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:
None
Brief Summary:
This clinical trial studies if a bowel management program with a retrograde rectal enema RRE for the treatment of low anterior resection syndrome LARS in rectal cancer patients is better than medical management alone Rectal cancer treatment can include a procedure where part of the rectum with cancer is removed and the remaining part of the rectum is reconnected to the colon this is called a low anterior resection of the rectum LARS is a common condition that can develop after undergoing a low anterior resection of the rectum LARS consists of any change in how the body performs defecation the discharge of feces from the body after undergoing a resection procedure Patients with LARS may experience fecal urgency incontinence increased frequency constipation feelings of incomplete bowel movement or bowel emptying difficulties Patients may experience individual symptoms of LARS or a combination of them A bowel management program assists patients with identifying a specific bowel management regimen that works best for managing symptoms of LARS A RRE consists of inserting a catheter through the anus into the rectum The RRE is designed to assist fecal emptying Medical management of LARS can include the use of fiber loperamide hydrochloride or pelvic floor physical therapy Fiber may help relieve constipation feelings of incomplete bowel movement or bowel emptying difficulties Loperamide hydrocholoride may help lessen fecal urgency incontinence or increased frequency Pelvic floor physical therapy may help restore strength in the rectum possibly helping to improve symptoms of LARS Participating in a bowel management program with a RRE may be more effective in treating LARS than medical management alone
Detailed Description:
PRIMARY OBJECTIVE
I To compare two approved pathways for treatment of low anterior resection syndrome LARS - a retrograde enema program versus a medical management pathway
SECONDARY OBJECTIVE
I The determination of feasibility to complete this treatment pathway
OUTLINE Patients are randomized to 1 of 2 groups
GROUP I Patients undergo a bowel management program comprising a medical management pathway fiber loperamide hydrochloride pelvic floor physical therapy in combination with RRE treatment for 1 year Patients use the RRE system to self administer an individualized enema regimen via the rectum Patients may undergo abdominal film x-rays throughout the trial
GROUP II Patients receive medical management comprising fiber loperamide hydrochloride and pelvic floor therapy for 1 year If medical management fails patients may then be referred for surgery with sacral nerve stimulator placement
Upon completion of study intervention all patients are followed up at 1 month 3 months and 1 year
I To compare two approved pathways for treatment of low anterior resection syndrome LARS - a retrograde enema program versus a medical management pathway
SECONDARY OBJECTIVE
I The determination of feasibility to complete this treatment pathway
OUTLINE Patients are randomized to 1 of 2 groups
GROUP I Patients undergo a bowel management program comprising a medical management pathway fiber loperamide hydrochloride pelvic floor physical therapy in combination with RRE treatment for 1 year Patients use the RRE system to self administer an individualized enema regimen via the rectum Patients may undergo abdominal film x-rays throughout the trial
GROUP II Patients receive medical management comprising fiber loperamide hydrochloride and pelvic floor therapy for 1 year If medical management fails patients may then be referred for surgery with sacral nerve stimulator placement
Upon completion of study intervention all patients are followed up at 1 month 3 months and 1 year
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NCI-2024-03173 | REGISTRY | CTRP Clinical Trial Reporting Program | None |