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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06424522
Other study ID # OSU-22312
Secondary ID NCI-2024-03173
Status Not yet recruiting
Phase Early Phase 1
First received
Last updated
Start date October 31, 2024
Est. completion date December 31, 2026

Study information

Verified date May 2024
Source Ohio State University Comprehensive Cancer Center
Contact The Ohio State Comprehensive Cancer Center
Phone 800-293-5066
Email OSUCCCClinicaltrials@osumc.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 80
Est. completion date December 31, 2026
Est. primary completion date December 31, 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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.)

Study Design


Intervention

Dietary Supplement:
Dietary Fiber
Receive dietary fiber
Procedure:
Enema Administration
Undergo RRE
Drug:
Loperamide Hydrochloride
Receive loperamide hydrochloride
Procedure:
Physical Therapy
Undergo pelvic floor physical therapy
Other:
Questionnaire Administration
Ancillary studies
Procedure:
X-Ray Imaging
Undergo abdominal film x-ray

Locations

Country Name City State
United States Ohio State University Comprehensive Cancer Center Columbus Ohio

Sponsors (1)

Lead Sponsor Collaborator
Ohio State University Comprehensive Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Fecal incontinence 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. Up to 1 year from start of treatment
Primary Effectiveness assessed using LARS validated scoring tool 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. Up to 1 year from start of treatment
Secondary Feasibility measured by Patient Satisfaction Survey 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. At 1 year from start of treatment
See also
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Recruiting NCT04040842 - International Low Anterior Resection Score Evaluation
Completed NCT05605600 - Translation of the International Consensus Definition of LARS Into a Bowl Dysfunction Severity Scoring Tool (New LARS Score)
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Active, not recruiting NCT05042700 - The Effect of Melatonin in Patients With Low Anterior Resection Syndrome Phase 2
Recruiting NCT04612569 - Feasibility and Impact of a Prehabilitation and Rehabilitation Program for the Continuity of Care in Severe Low Anterior Resection Syndrome.
Completed NCT04896879 - Experiences and Needs of Patients, Their Informal Caregiver and Healthcare Professionals Regarding LARS
Recruiting NCT06162143 - Effect of Gelsectan® in the Treatment of Low Anterior Resection Syndrome
Withdrawn NCT03257332 - Determining Early Development of Faecal Incontinence and Anorectal Muscle Function After Surgery for Rectal Cancer.
Completed NCT03916549 - Acupuncture in Low Anterior Resection Syndrome Treatment Phase 1
Completed NCT05020132 - Bowel Dysfunction After Rectal Cancer Treatment
Completed NCT03598231 - Effectiveness of Sacral Neuromodulation in Low Anterior Resection Syndrome N/A
Recruiting NCT05420870 - Effect of Exercise on Bowel Function in Colorectal Cancer Survivors N/A
Active, not recruiting NCT05319054 - Pathway of Low Anterior Resection Syndrome Relief After Surgery: a Feasibility Study N/A
Completed NCT01589471 - The Value of Botox-A for Management of Low Anterior Resection Syndrome Phase 2
Completed NCT03215017 - Effect of Treatment of Low Anterior Resection Syndrome After Rectal Cancer Surgery N/A
Completed NCT05129215 - Development and Validation of The Post-RT LARS Prediction Model (PORTLARS)
Recruiting NCT05682157 - Paula Method of Exercises in Patients With LARS Syndrome:Randomized Controlled Trial N/A

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