Puborectalis Syndrome as a Phenotype of Dyssynergic Defecation in Chronic Constipation: a Comparative Study of Defecography,High-resolution Anorectal Manometry, and Pelvic Floor Ultrasound
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 164
- 试验地点
- 1
- 主要终点
- Rectal emptying rate，（%）
研究概览
简要总结
Patients with suspected DD who met the Rome IV criteria were divided into the DD group and other types of constipation groups. The differences between the two groups were analyzed to explore the precise diagnostic scheme for DD.
详细描述
This study was conducted solely at the Army Specialized Medical Center and was a single-center, bidirectional cohort study. Patients with suspected dyssynergic defecation who visited the constipation specialty clinic of Daping Hospital were collected. After the patients signed the informed consent form, they were asked to fill out the questionnaire (general clinical data questionnaire, Wexner constipation rating scale, ODS rating scale, and constipation patient quality of life scale (PAC-QOL)). The baseline data of the patients (such as age, gender, symptoms, constipation scale scores, intestinal satisfaction scores, etc.) and the results of anorectal manometry, defecography, and perineal ultrasound were statistically analyzed. Patients meeting the Rome IV criteria were grouped through DFG, ARM, and pelvic floor ultrasound examination. The differences in clinical main symptoms, constipation scores, defecography, perineal ultrasound, etc. between the two groups were observed, and the roles and correlations of each parameter in diagnosis were analyzed.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Other
入排标准
- 年龄范围
- 16 Years 至 85 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ranges from 16 to 85 years old.
- •Constipation patients should meet the Rome Ⅳ criteria for chronic constipation (must include two or more of the following: ① At least 25% of bowel movements are strenuous; ② At least 25% of bowel movements are lumpy or hard stools; ③ At least 25% of bowel movements are accompanied by a sense of incomplete evacuation; ④ At least 25% of bowel movements are associated with a feeling of anorectal obstruction or blockage; ⑤ At least 25% of bowel movements require manual assistance; ⑥ Fewer than 3 bowel movements per week). The healthy volunteer group has no above - mentioned constipation symptoms.
- •Participants should be able to understand and complete relevant questionnaires.
- •Participants should be willing to follow the research protocol and sign the informed consent form.
排除标准
- •Pregnant women and lactating women
- •Suffering from gastrointestinal and other malignant tumors
- •Suffering from diseases such as diabetes and Parkinson's disease
- •Currently participating in other clinical trials
结局指标
主要结局
Rectal emptying rate，（%）
时间窗: Baseline assessment
Rectal emptying rate is defined as the reduction in rectal area from pre-evacuation to post-evacuation, expressed as a percentage of the pre-evacuation area, as assessed by defecography.
次要结局
- Disease duration,(year)(Baseline assessment)
- Bristol Stool Form Scale score(Baseline assessment)
- Obstructed Defecation Syndrome score，（ODS score）(Baseline assessment)
- Cleveland Clinic Constipation Score,(CCCS)(Baseline assessment)
- Patient Assessment of Constipation Quality of Life total score，（PAC-QOL score）(Baseline assessment)
- Self-Rating Anxiety Scale score，（SAS score）(Baseline assessment)
- Body Mass Index(Baseline assessment)
- ARA change on DFG，(°)(Baseline assessment)
- Anal canal diameter on DFG，（mm）(Baseline assessment)
- PRS on DFG(Baseline assessment)
- IRP on DFG(Baseline assessment)
- Rectocele on DFG(Baseline assessment)
- Anal Resting Pressure，（mmHg）(Baseline assessment)
- Anal Squeeze Pressure,(mmHg)(Baseline assessment)
- Rectal propulsive pressure,(mmHg)(Baseline assessment)
- Anal relaxation rate,(%)(Baseline assessment)
- DD on HR-ARM(Baseline assessment)
- ARA change on TPUS,(°)(Baseline assessment)
- Right PRM thickness change on TPUS,(mm)(Baseline assessment)
- Left PRM thickness change on TPUS,(mm)(Baseline assessment)
- PRS on TPUS(Baseline assessment)
研究者
Weidong Tong
Director
Third Military Medical University