Bowel Management Program for Colorectal Cancer
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores a new method to assist individuals with low anterior resection syndrome (LARS), a condition that can cause frequent or urgent bowel movements and constipation after rectal cancer surgery. The study compares two approaches: a combination of a bowel management program with a retrograde rectal enema (a method to empty the bowels) and standard medical management, which includes fiber supplements, medications, and pelvic floor exercises. Individuals who have undergone rectal cancer surgery and now experience LARS might be suitable candidates for this trial. As an unphased trial, this study provides a unique opportunity to investigate innovative treatments for LARS.
Do I need to stop my current medications for the trial?
The trial protocol does not specify if you need to stop your current medications. It might be best to discuss this with the research team or your doctor.
What prior data suggests that this bowel management program with retrograde rectal enema is safe for patients with low anterior resection syndrome?
Research has shown that retrograde rectal enemas (RRE) can help manage symptoms of low anterior resection syndrome (LARS), a condition often occurring after rectal cancer surgery. Studies have found that RRE reduces symptoms like sudden bowel movements and incontinence, leading to an improved LARS score.
RRE has been well-received, with no major safety issues reported in studies. While some individuals might experience mild discomfort during the procedure, serious side effects are rare. This suggests that RRE is a safe option for managing LARS symptoms.12345Why are researchers excited about this trial?
Researchers are excited about this trial because it explores a comprehensive bowel management program that includes a unique approach using retrograde rectal enemas (RRE). Unlike standard treatments for colorectal cancer-related bowel issues, which typically involve medications like fiber and loperamide or surgical options like sacral nerve stimulation, this program combines medical management with a self-administered enema regimen. The RRE offers a new delivery method that allows patients to tailor their treatment to their individual needs, potentially enhancing comfort and effectiveness. By incorporating pelvic floor physical therapy alongside RRE, the trial aims to improve bowel control and quality of life significantly for patients.
What evidence suggests that this bowel management program with retrograde rectal enema is effective for low anterior resection syndrome?
Research has shown that a retrograde rectal enema (RRE) can help manage low anterior resection syndrome (LARS) in individuals who have had rectal cancer. Studies have found that RRE reduces LARS symptoms such as urgency, loss of bowel control, and constipation. In this trial, participants in Group I will follow a bowel management program that includes RRE along with medical treatments like fiber supplements, loperamide hydrochloride (a medication to reduce diarrhea), and pelvic floor exercises. Participants in Group II will receive only the medical treatments. Patients who used RRE reported better symptom control compared to those who only used medical treatments. Overall, RRE appears to be a promising method for improving bowel function after rectal surgery.12456
Who Is on the Research Team?
Alessandra C Gasior, DO
Principal Investigator
Ohio State University Comprehensive Cancer Center
Are You a Good Fit for This Trial?
This trial is for rectal cancer patients who have undergone a low anterior resection and are now experiencing LARS, which includes symptoms like fecal urgency, incontinence, constipation, or difficulty emptying the bowel. The study seeks individuals struggling with these post-surgery changes to their bowel habits.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants undergo a bowel management program with either RRE and medical management or medical management alone for 1 year
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Retrograde Rectal Enema
Trial Overview
The study is testing if a bowel management program using retrograde rectal enemas (RRE) can better manage LARS symptoms compared to standard medical treatments alone. This involves inserting a catheter into the rectum to help with fecal emptying alongside dietary adjustments, medication like loperamide hydrochloride, and physical therapy.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Active Control
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.
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.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Ohio State University Comprehensive Cancer Center
Lead Sponsor
Published Research Related to This Trial
Citations
The efficacy of retrograde and antegrade enemas in ...
According to our findings, enema, particularly retrograde enema, is effective in managing LARS and can lower the LARS score. However, the ...
A Bowel Management Program (Retrograde Rectal Enema ...
Participating in a bowel management program with a RRE may be more effective in treating LARS than medical management alone. ... Patients with ...
Bowel Management Program for Colorectal Cancer
... Retrograde Rectal Enema will have tolerable side effects & efficacy for patients with Rectal Cancer, Anterior Resection Syndrome and Colorectal Cancer. See
(PDF) The efficacy of retrograde and antegrade enemas in ...
Subgroup analysis based on the type of enema were performed, with three European studies using retrograde enema and one Asian study using ...
5.
clinicaltrials.gov
clinicaltrials.gov/study/NCT06717854?term=AREA%5BConditionSearch%5D((vohwinkel%20syndrome%20variants%20from)%20OR%20(lar))&rank=2Retrograde and Antegrade Enema for Prevention of LARS ...
To compare the effects and advantages and disadvantages of antegrade and retrograde enema, and to investigate whether these two types of enema can provide safe ...
6.
app.trialscreen.org
app.trialscreen.org/trials/early-phase-1-bowel-management-program-retrograde-rectal-enema-treatment-trial-nct06424522A Bowel Management Program (Retrograde Rectal Enema ...
This Interventional study is looking for people with Low Anterior Resection Syndrome, Rectal Carcinoma in Columbus United States to take part.
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