Puborectalis Syndrome as a Phenotype of Dyssynergic Defecation in Chronic Constipation: a Comparative Study of Defecography,High-resolution Anorectal Manometry, and Pelvic Floor Ultrasound
2026年6月28日 更新者：Weidong Tong、Third Military Medical University
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.
研究概览
地位
完全的
详细说明
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.
研究类型
观察性的
注册 (实际的)
164
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
-
-
Chongqing Municipality
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Yuzhong、Chongqing Municipality、中国、400042
- Army Medical Center (Daping Hospital)
-
-
参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
- 孩子
- 成人
- 年长者
接受健康志愿者
不
取样方法
概率样本
研究人群
patients with suspected PRS-related DD
描述
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
队列和干预
团体/队列 |
干预/治疗 |
|---|---|
|
patients with suspected PRS-related DD
|
Analysis of inter-group differences
|
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Rectal emptying rate，（%）
大体时间：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.
|
Baseline assessment
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Obstructed Defecation Syndrome score，（ODS score）
大体时间：Baseline assessment
|
the minimum value is 0,and maximum value is 31; a higher scores mean a worse outcome.
|
Baseline assessment
|
|
Cleveland Clinic Constipation Score,(CCCS)
大体时间：Baseline assessment
|
the minimum value is 0,and maximum value is 30; a higher scores mean a worse outcome.
|
Baseline assessment
|
|
Patient Assessment of Constipation Quality of Life total score，（PAC-QOL score）
大体时间：Baseline assessment
|
the minimum value is 0,and maximum value is 112; a higher scores mean a worse outcome.
|
Baseline assessment
|
|
Self-Rating Anxiety Scale score，（SAS score）
大体时间：Baseline assessment
|
the minimum value is 25,and maximum value is 100; a higher scores mean a worse outcome.
|
Baseline assessment
|
|
Bristol Stool Form Scale score
大体时间：Baseline assessment
|
the minimum value is 1,and maximum value is 7; a higher scores mean a worse outcome.
|
Baseline assessment
|
|
Body Mass Index
大体时间：Baseline assessment
|
Baseline assessment
|
|
|
Disease duration,(year)
大体时间：Baseline assessment
|
Baseline assessment
|
|
|
ARA change on DFG，(°)
大体时间：Baseline assessment
|
changes in anorectal angle during defecography
|
Baseline assessment
|
|
Anal canal diameter on DFG，（mm）
大体时间：Baseline assessment
|
anal canal diameter during straining on DFG
|
Baseline assessment
|
|
PRS on DFG
大体时间：Baseline assessment
|
Puborectalis syndrome indicated by the defecography diagnostic report.
|
Baseline assessment
|
|
IRP on DFG
大体时间：Baseline assessment
|
Internal rectal prolapse indicated by the defecography diagnostic report.
|
Baseline assessment
|
|
Rectocele on DFG
大体时间：Baseline assessment
|
Rectocele indicated by the defecography diagnostic report.
|
Baseline assessment
|
|
Anal Resting Pressure，（mmHg）
大体时间：Baseline assessment
|
Anal Resting Pressure measured by High-resolution Anorectal Manometry
|
Baseline assessment
|
|
Anal Squeeze Pressure,(mmHg)
大体时间：Baseline assessment
|
Anal Squeeze Pressure measured by High-resolution Anorectal Manometry
|
Baseline assessment
|
|
Rectal propulsive pressure,(mmHg)
大体时间：Baseline assessment
|
Rectal propulsive pressure measured by High-resolution Anorectal Manometry
|
Baseline assessment
|
|
Anal relaxation rate,(%)
大体时间：Baseline assessment
|
Anal relaxation rate measured by High-resolution Anorectal Manometry during defecation
|
Baseline assessment
|
|
DD on HR-ARM
大体时间：Baseline assessment
|
Dyssynergic defecation(DD) reported by high-resolution anorectal manometry parameters, with diagnostic criteria of rectal pressure during straining >45mmHg and anal canal relaxation rate <20%.
|
Baseline assessment
|
|
ARA change on TPUS,(°)
大体时间：Baseline assessment
|
changes in anorectal angle during evacuation measured by Transperineal Ultrasound
|
Baseline assessment
|
|
Right PRM thickness change on TPUS,(mm)
大体时间：Baseline assessment
|
Changes in right puborectalis muscle thickness during defecation measured by Transperineal Ultrasound
|
Baseline assessment
|
|
Left PRM thickness change on TPUS,(mm)
大体时间：Baseline assessment
|
Changes in left puborectalis muscle thickness during defecation measured by Transperineal Ultrasound
|
Baseline assessment
|
|
PRS on TPUS
大体时间：Baseline assessment
|
Puborectalis syndrome(PRS) indicated by the transperineal ultrasound diagnostic report
|
Baseline assessment
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 研究主任：Weidong Tong, MD、Army Medical Center (Daping Hospital)
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2023年7月21日
初级完成 (实际的)
2026年5月31日
研究完成 (实际的)
2026年5月31日
研究注册日期
首次提交
2026年6月16日
首先提交符合 QC 标准的
2026年6月28日
首次发布 (实际的)
2026年7月6日
研究记录更新
最后更新发布 (实际的)
2026年7月6日
上次提交的符合 QC 标准的更新
2026年6月28日
最后验证
2023年7月1日
更多信息
与本研究相关的术语
其他研究编号
- PRS202409
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