Point-of-care Anorectal Testing to Predict Outcomes With Biofeedback Therapy: Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 99
- 试验地点
- 2
- 主要终点
- Assessing Change of Global Constipation Symptoms at completion of physical therapy
研究概览
简要总结
To prospectively evaluate the clinical utility of baseline anorectal function testing using a point-of-care device in predicting response of chronically constipated patients to physical therapy biofeedback training.
详细描述
Chronic constipation affects 10-20% of the US population and can impact quality-of-life to a similar degree as congestive heart failure or rheumatoid arthritis. Notably, 700,000 individuals present to the emergency department for constipation each year in the US and $10 billion is spent annually on laxative therapy. For symptomatic chronic constipation refractory to fiber or laxative therapy, clinical practice guidelines recommend physiological testing to identify abnormalities in anorectal function as the next step5. Abnormal anorectal function testing (including anorectal manometry and balloon expulsion testing) suggests an evacuation disorder, the most common of which is dyssynergic defecation or dyssynergia. Identification of patients with an evacuation disorder as a primary driver of constipation is important since therapy can then be targeted.
To enable standardized, accessible chronic constipation testing for general gastroenterologists, the investigators invented an office-based, point-of-care Rectal Expulsion Device (RED). By incorporating RED into a general gastroenterologist's outpatient visit, chronically constipated individuals with abnormal anorectal function can be identified quickly and directly triaged to biofeedback therapy. Thus, RED offers the possibility of disrupting the current treatment paradigm by enabling an initial biomarker based strategy for patients with chronic constipation. Before such a process of care can be realized, there is a critical need for prospective data to determine the best setting for anorectal function testing in the clinical care pathway. The investigators aim to prospectively evaluate the clinical utility of baseline anorectal function testing using RED in identifying chronically constipated patients with evacuation disorders who would benefit from biofeedback therapy.
The investigators will conduct a 12-week clinical trial enrolling individuals with laxative-refractory chronic constipation. All study participants will undergo RED and traditional lab-based testing at baseline, followed by a standardized three-session biofeedback protocol for dyssynergia.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •individuals aged 18-80 with a body mass index of 18 to 40 kg/m2 and a primary ICD-10 diagnosis for constipation (K59*) or referral for constipation.
- •Does the patient meet Rome IV criteria for functional constipation (FC)?
- •Does the patient report that fiber or laxative therapy has been ineffective to treat constipation in a documented treatment trial for at least two weeks prior to screening?
- •Patient is already scheduled for anorectal manometry and physical therapy as part of routine care.
- •The patient must agree to maintain their current dietary fiber intake and osmotic or bulk-forming laxative regimen (if any) throughout the trial
- •The patient must agree to use stimulant laxatives (such as magnesium citrate [Milk of Magnesia], senna or bisacodyl [Dulcolax]) NO MORE THAN two days per week during the trial
- •Patient must be able to participate in physical therapy for biofeedback
- •Individuals must have health insurance coverage to undergo anorectal function testing and biofeedback therapy as part of their non-study routine clinical care
排除标准
- •adults unable to consent, individuals who are not yet adults, pregnant women, and prisoners, as they would be unable to reasonably comply with physical therapy within the duration of the study and would thus undergo unnecessary testing.
- •Patient must NOT have tried biofeedback therapy or undergone anorectal manometry previously
- •Patient must NOT report prior SURGERY involving the colon or rectum (including surgery for anal fissure, rectal prolapse)
- •Patient must NOT recent opioid use within 30 days of enrollment
- •Patient must NOT report a neurodegenerative condition (i.e. Parkinson's disease, dementia, multiple sclerosis, spinal cord injury) or uncontrolled inflammatory bowel disease
- •Patient must NOT have used linaclotide (Linzess), lubiprostone (Amitiza), plecanatide (Trulance), tegaserod (Zelnorm) or prucalopride (Motegrity) within 30 days prior to enrollment. Patients MUST agree not to use these agents during the trial
结局指标
主要结局
Assessing Change of Global Constipation Symptoms at completion of physical therapy
时间窗: Week 0 and 12
The Patient Assessment of Constipation-Symptoms (PAC-SYM) questionnaire is a short, easily-completed instrument for assessing global constipation symptoms. A total PAC-SYM score ranges from 0 to 48.
次要结局
- Measure Change in Severity of Abdominal Discomfort for Bowel Movements at completion of physical therapy(Week 0 and Week 12)
- Measure Change in Severity of Straining for Bowel Movements at completion of physical therapy(Week 0 and Week 12)
- Measure Change in Severity of Bloating for Bowel Movements at completion of physical therapy(Week 0 and Week 12)
- Measure Change in Bowel Movement Frequency at completion of physical therapy(Week 0 and Week 12)
- Measure Change in Bowel Movement Form at completion of physical therapy(Week 0 and Week 12)
- Measure Change in Severity of Constipation Severity for Bowel Movements at completion of physical therapy(Week 0 and Week 12)
- Assess the Level of Treatment Satisfaction(Week 12)
研究者
Eric.D.Shah
Director, Center for Gastrointestinal Motility, Esophageal and Swallowing Disorders
Dartmouth-Hitchcock Medical Center