NCT07225803招募中不适用
Management of Dyssynergic Defecation
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- Mayo Clinic
- 入组人数
- 200
- 试验地点
- 2
- 主要终点
- Change in rectoanal gradient during evacuation
研究概览
简要总结
The purpose of this research is to better understand constipation and improve biofeedback treatments.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 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
- •Men and women aged 18-80 years who are able and willing to provide written informed consent and to comply with the requirements for the entire study
- •Satisfy Rome III criteria for functional constipation and/or irritable bowel syndrome as assessed by questionnaires and objective evidence of dyssynergic defecation on anorectal testing
排除标准
- •Clinical evidence of significant cardiovascular, respiratory, renal, hepatic, gastrointestinal, hematological, neurological, psychiatric or other diseases that may interfere with the objectives of the study and/or pose safety concerns.
- •History of total, hemi- or subtotal colectomy at any time or other abdominal operations within 60 days prior to entry into the study. Segmental resection of the colon (e.g. sigmoid resection) for diverticulitis will be permitted.
- •Current anal fissure
- •Clinically significant structural abnormalities (eg, rectocele > 4cm, large enterocele, full thickness rectal prolapse) that, in the opinion of the investigator, are likely contributing to symptoms
- •Current or past history of colon or rectal cancer, scleroderma, inflammatory bowel disease, congenital anorectal abnormalities, solitary rectal ulcer syndrome, rectal resection or pelvic irradiation
- •Pregnant or nursing women, prisoners and institutionalized individuals
- •BMI >35 kg/m2
- •Use of opioid analgesics or GLP-1 receptor agonists. Patients on opioids will be allowed to participate if they have discontinued them for at least 1 week before the date of screening and are willing to stay off them for the duration of the study.
- •Current use of anticholinergics (eg. amitriptyline, hyoscyamine). Patients who use low dose tricyclic antidepressants (nortriptyline or amitriptyline up to 50 mg/day) will be eligible provided they do not increase the dose during the study period. Patients on higher doses are eligible to participate if it is safe and they are willing to reduce their medication dose at least 3 days (72 hrs) before the date of screening and are willing to stay off them till the study is complete.
- •Current use of laxatives (Ex-lax, senna, herbal supplements), linaclotide, lubiprostone, and prucalopride to treat constipation- patients using these medications will be eligible to participate if they can discontinue the medication at least 3 days (72 hrs.) before the date of screening and are willing to stay off them till the study is complete (As detailed later, all participants can use Miralax throughout the study).
- •Any other factors that increase the risk to participants of participating in the study and/or undermine the integrity of the data.
结局指标
主要结局
Change in rectoanal gradient during evacuation
时间窗: Baseline, through study completion, an average of 16 weeks
Rectoanal gradient during evacuation is the pressure difference between the rectum and the anal canal during simulated evacuation, measured in millimeters of mercury (mmHg).
Change in rectal pressure during evacuation
时间窗: Baseline, through study completion, an average of 16 weeks
Rectal pressure during evacuation is the difference in rectal pressure during - before evacuation. Results are measured in millimeters of mercury (mmHg).
Change in balloon expulsion time
时间窗: Baseline, through study completion, an average of 16 weeks
Rectal balloon expulsion directly assesses evacuation. Patients will be asked to expel a rectal balloon inflated up to 50 ml of water. The time required to expel the balloon will be measured and reported in seconds.
Change in rectal emptying time
时间窗: Baseline, through study completion, an average of 16 weeks
Rectal emptying will be assessed via fecoflowmetry by measuring the time required to defecate (seconds) artificial stool from the rectum
Change in rectal emptying rate
时间窗: Baseline, through study completion, an average of 16 weeks
Rectal emptying will be assessed via fecoflowmetry by measuring the amount (gm) of artificial stool from the rectum. The 2 metrics - amount and time - are integrated to measure amount (gm) evacuated per unit time (second) (gm/sec).
次要结局
- Change in anal digitation(Baseline, through study completion, an average of 16 weeks, 3 months post completion, 12 months post completion)
- Change in Patient Assessment of Constipation-Symptoms (PAC-SYM) questionnaire(Baseline, through study completion, an average of 16 weeks, 3 months post completion, 12 months post completion)
- Change in Patient Assessment of Constipation - Quality of Life (PAC-QOL) questionnaire(Baseline, through study completion, an average of 16 weeks, 3 months post completion , 12 months post completion)
- Physical Activity Rating Scale(Baseline)
- Quebec User Evaluation of Satisfaction with Assistive Technology questionnaire(through study completion, an average of 16 weeks)
- Change in stool frequency(Baseline, through study completion, an average of 16 weeks, 3 months post completion, 12 months post completion)
- Change in stool consistency(Baseline, through study completion, an average of 16 weeks, 3 months post completion, 12 months post completion)
- Change in sense of incomplete evacuation(Baseline, through study completion, an average of 16 weeks, 3 months post completion, 12 months post completion)
- Change in spontaneous bowel movements(Baseline, through study completion, an average of 16 weeks, 3 months post completion, 12 months post completion)
- Change in pain during bowel movements(Baseline, through study completion, an average of 16 weeks, 3 months post completion, 12 months post completion)
- Change in bowel symptoms before and after biofeedback therapy(Baseline, through study completion, an average of 16 weeks, 3 months post completion, 12 months post completion)
- Change in Hospital Anxiety and Depression (HAD) score(Baseline, through study completion, an average of 16 weeks)
- Change in forced vital capacity(Baseline, through study completion, an average of 16 weeks)
- Change in forced expiratory volume(Baseline, through study completion, an average of 16 weeks)
- Change in forced expiratory time(Baseline, through study completion, an average of 16 weeks)
- Change in peak inspiratory flows(Baseline, through study completion, an average of 16 weeks)
- Change in peak expiratory flows(Baseline, through study completion, an average of 16 weeks)
- Change in forced expiratory volume/forced vital capacity ratio(Baseline, through study completion, an average of 16 weeks)
- Change in forced expiratory flow at 25-75% of forced vital capacity(Baseline, through study completion, an average of 16 weeks)
- Change in forced expiratory flow at 50% of forced vital capacity(Baseline, through study completion, an average of 16 weeks)
- Change in forced inspiratory vital capacity(Baseline, through study completion, an average of 16 weeks)
- Change in peak inspiratory pressure(Baseline, through study completion, an average of 16 weeks)
- Change in peak expiratory pressure(Baseline, through study completion, an average of 16 weeks)
研究者
Adil Bharucha, MBBS, MD
Principal Investigator
Mayo Clinic
研究点 (2)
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