CONSIST- Constipation Symptoms Observational Study: A Multicenter, Cross-Sectional Study to Assess Different Diagnostic Criteria of Chronic Constipation in Asia
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 461
- 主要终点
- The percentage of participants for whom the CC diagnosis, according to the ANMA CC diagnostic tool, disagrees with the CC diagnosis according to the ROME III diagnosis criteria
研究概览
简要总结
The purpose of the study is to evaluate the differences or similarities in the results obtained with two different scoring systems for chronic constipation in Asian participants consulting in gastroenterology clinics (the Asian Neurogastro-enterology and Motility Association (ANMA) chronic constipation (CC) diagnostic tool (diagnosis questionnaire) and the ROME III diagnosis criteria (western gold standard).
详细描述
This is an observational (investigators observe participants and measure outcomes without assigning a treatment), non-product specific, regional multicenter (conducted at multiple sites) and multicountry, cross-sectional (observation of all members of a population at one specific point in time), epidemiological study (study of the patterns, causes, and effects of health and disease conditions in defined populations). The study will be conducted in 3 steps. In Step 1 (screening phase), all adult participants visiting their gastroenterologist (for any condition) within a 3 month period will be screened using the ANMA screening worksheet. In Step 2A (diagnosis phase - during investigator chosen consecutive consultation days), all the eligible participants will be required to complete a combination Diagnosis Questionnaire to obtain a diagnosis of CC based on different criteria: self-defined, investigator-judgement, ANMA tool, and ROME III criteria. Details about previous examinations and demography will also be collected during Step 2A of the study, together with Patient Assessment of Constipation Symptoms (PAC-SYM). Participants with a positive response to the ANMA diagnosis tool will proceed to Step 2B. In Step 2B (documentation phase), more information about the participant will be collected using the documentation questionnaire: demography, medical history, history of CC, current symptoms of CC, comorbidities, past and current medications for CC. The Patient Assessment of Constipation-Quality of Life (PAC-QOL) scale will be used to assess participant's satisfaction with their current treatment. Approximately 2000 participants will be screened to yield approximately 400 participants with suspected chronic constipation for whom the Diagnostic and Documentation Questionnaire will be filled in. Safety evaluations will include assessment of adverse events and special reporting situations such as pregnancy.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants who have at least 1 of the symptoms listed in the Screening Worksheet and the symptom has been present for at least 3 months
- •Participants have signed the informed consent document indicating that they understand the purpose of and procedures required for the study and are willing to complete all the questions on the questionnaires
排除标准
- •Participants judged by the investigator to suffer from chronic constipation that is drug-induced or with secondary causes eg, endocrine, metabolic or neurological disorders, surgical obstruction, megacolon/megarectum, a diagnosis of pseudo-obstruction and organic disorders of the large bowel
- •Pregnant female participants
研究组 & 干预措施
Asian participants with chronic constipation
Asian participants diagnosed with chronic constipation using Asian Neurogastro-enterology and Motility Association (ANMA) diagnostic questionnaire.
干预措施: No intervention (Drug)
结局指标
主要结局
The percentage of participants for whom the CC diagnosis, according to the ANMA CC diagnostic tool, disagrees with the CC diagnosis according to the ROME III diagnosis criteria
时间窗: Day 1
The percentage of participants for whom the chronic constipation (CC) diagnosis, according to the Asian Neurogastro-enterology and Motility Association (ANMA) CC diagnostic tool, agrees with the CC diagnosis according to the ROME III diagnosis criteria
时间窗: Day 1
ANMA CC diagnostic criteria: hard stools; difficulty to pass stool; sensation of incomplete evacuation; less than 3 bowel movements per week; straining; sensation of anorectal obstruction; manual maneuvers; CC symptoms for the last 3 months with a symptom onset at least 3 months before diagnosis. ROME III CC diagnosis criteria (any 2 or more): straining; lumpy or hard stools; sensation of incomplete evacuation; sensation of anorectal obstruction; manual maneuvers; less than 3 bowel movements per week; CC symptoms for the last 3 months with a symptom onset at least 6 months before diagnosis.
次要结局
- Participant assessment of current treatment as measured by the Constipation-Quality of Life (PAC-QOL) questionnaire(Day 1)
- The percentage of participants with participant self-defined CC(Day 1)
- The percentage of ROME-positive participants who need CC therapy(Day 1)
- The percentage of ROME-negative but ANMA positive participants who need CC therapy(Day 1)
- The percentage of participants with a diagnosis of CC according to the ROME III diagnosis criteria(Day 1)
- The percentage of participants with a diagnosis of CC according to investigator judgement(Day 1)
- The percentage of participants with a diagnosis of CC according to the ANMA CC diagnostic tool(Day 1)