Low Anterior Resection Syndrome, Rectal Carcinoma
Conditions
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 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.
Interventions
DIETARY_SUPPLEMENTDietary Fiber
Receive dietary fiber
PROCEDUREEnema Administration
Undergo RRE
Receive loperamide hydrochloride
PROCEDUREPhysical Therapy
Undergo pelvic floor physical therapy
OTHERQuestionnaire Administration
Ancillary studies
PROCEDUREX-Ray Imaging
Undergo abdominal film x-ray
Sponsors
Ohio State University Comprehensive Cancer Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age ≥ 18 years old * Moderate to Severe LARS diagnosis * Patients with history of rectal cancer that was treated with proctectomy * Has undergone standard medical management without improvement of symptoms for 3-6 months
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 with progressive neurological disease * Patients with active or recurrent sacral infection * Patients \< 18 years old * Active sacral nerve simulator * Pregnant or planning to become pregnant during the treatment portion of the study * 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.)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Fecal incontinence | Up to 1 year from start of treatment | Will be measured using a validated scoring tool for LARS (Memorial Sloan Kettering Cancer Center Bowel Function Instrument Questionnaire \[MSKCC BFI\]). Effect size (Cohen's d \> 0.80) will be computed to ensure the effect of findings. P \< 0.05 is considered significant. Statistical analysis will be conducted using linear or nonlinear mixed modelling as found appropriate by the statistician. |
| Effectiveness assessed using LARS validated scoring tool | Up to 1 year from start of treatment | Will be assessed using LARS validated scoring tool. Effect size (Cohen's d \> 0.80) will be computed to ensure the effect of findings. P \< 0.05 is considered significant. Statistical analysis will be conducted using linear or nonlinear mixed modelling as found appropriate by the statistician. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Feasibility measured by Patient Satisfaction Survey | At 1 year from start of treatment | Will be assessed by administering a patient satisfaction survey post treatment. Effect size (Cohen's d \> 0.80) will be computed to ensure the effect of findings. P \< 0.05 is considered significant. Statistical analysis will be conducted using linear or nonlinear mixed modelling as found appropriate by the statistician. |
Countries
United States
Contacts
CONTACTThe Ohio State Comprehensive Cancer Center
PRINCIPAL_INVESTIGATORAlessandra C Gasior, DO
Ohio State University Comprehensive Cancer Center
Outcome results
None listed