Trial Title:
A Bowel Management Program (Retrograde Rectal Enema) for the Treatment of Low Anterior Resection Syndrome in Rectal Cancer Patients
NCT ID:
NCT06424522
Condition:
Low Anterior Resection Syndrome
Rectal Carcinoma
Conditions: Official terms:
Low Anterior Resection Syndrome
Syndrome
Loperamide
Antidiarrheals
Study type:
Interventional
Study phase:
Early Phase 1
Overall status:
Not yet recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Dietary Supplement
Intervention name:
Dietary Fiber
Description:
Receive dietary fiber
Arm group label:
Group I (RRE, medical management)
Arm group label:
Group II (medical management)
Other name:
Fiber
Intervention type:
Procedure
Intervention name:
Enema Administration
Description:
Undergo RRE
Arm group label:
Group I (RRE, medical management)
Other name:
Enema
Other name:
Enema Injection
Intervention type:
Drug
Intervention name:
Loperamide Hydrochloride
Description:
Receive loperamide hydrochloride
Arm group label:
Group I (RRE, medical management)
Arm group label:
Group II (medical management)
Other name:
Imodium
Other name:
Imodium A-D
Intervention type:
Procedure
Intervention name:
Physical Therapy
Description:
Undergo pelvic floor physical therapy
Arm group label:
Group I (RRE, medical management)
Arm group label:
Group II (medical management)
Other name:
Physiatric Procedure
Other name:
Physical Medicine Procedure
Other name:
Physical Therapeutics
Other name:
Physical Therapy Procedure
Other name:
Physiotherapy
Other name:
Physiotherapy Procedure
Intervention type:
Other
Intervention name:
Questionnaire Administration
Description:
Ancillary studies
Arm group label:
Group I (RRE, medical management)
Arm group label:
Group II (medical management)
Intervention type:
Procedure
Intervention name:
X-Ray Imaging
Description:
Undergo abdominal film x-ray
Arm group label:
Group I (RRE, medical management)
Other name:
Conventional X-Ray
Other name:
Diagnostic Radiology
Other name:
Medical Imaging, X-Ray
Other name:
Plain film radiographs
Other name:
Radiographic Imaging
Other name:
Radiographic imaging procedure (procedure)
Other name:
Radiography
Other name:
Static X-Ray
Other name:
X-Ray
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 patient's 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.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- Age ≥ 18 years old
- LARS diagnosis
- Patients with history of rectal cancer
Exclusion Criteria:
- Patients presenting with significant stricture that need a definitive surgical
management strategy; patients with minor or clinically negligible strictures can
still be candidates. Patients who are able to pass the catheter and the balloon per
rectum may be candidates after a digital rectal exam at their initial visit
- Patients with any chemo or radiation therapy in the last 6 months
- Patients who currently have colorectal cancer
- Patients with recurrent colorectal cancer
- Patients who have undergone a colorectal surgical procedure within the last three
months
- Patients < 18 years old
- Active sacral nerve simulator
- Altered mental status or mental disability that would alter ability to
self-administer enema
- Any reason the research team believes the subject is not an appropriate candidate
for this study (i.e., transportation issues, history of no-show appointments, lack
of reliable communications, vulnerable population(s), etc.)
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Ohio State University Comprehensive Cancer Center
Address:
City:
Columbus
Zip:
43210
Country:
United States
Contact:
Last name:
Alessandra C. Gasior, DO
Phone:
614-722-3879
Email:
Alessandra.gasior@osumc.edu
Investigator:
Last name:
Alessandra C. Gasior, DO
Email:
Principal Investigator
Start date:
October 31, 2024
Completion date:
December 31, 2026
Lead sponsor:
Agency:
Ohio State University Comprehensive Cancer Center
Agency class:
Other
Source:
Ohio State University Comprehensive Cancer Center
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06424522
http://cancer.osu.edu
