Skip to main content
OpenTrials
Completed

NCT Number: NCT07683390

Puborectalis Syndrome as a Phenotype of Dyssynergic Defecation in Chronic Constipation: a Comparative Study of Defecography,High-resolution Anorectal Manometry, and Pelvic Floor Ultrasound

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

16 year–85 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Army Medical Center (Daping Hospital)

Yuzhong, Chongqing Municipality, 400042, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Analysis of inter-group differences

Other

Analysis of inter-group differences

Primary outcomes

  1. Rectal emptying rate,(%)

    Time frame: 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.

Secondary outcomes

  1. Obstructed Defecation Syndrome score,(ODS score)

    Time frame: Baseline assessment

    the minimum value is 0,and maximum value is 31; a higher scores mean a worse outcome.

  2. Cleveland Clinic Constipation Score,(CCCS)

    Time frame: Baseline assessment

    the minimum value is 0,and maximum value is 30; a higher scores mean a worse outcome.

  3. Patient Assessment of Constipation Quality of Life total score,(PAC-QOL score)

    Time frame: Baseline assessment

    the minimum value is 0,and maximum value is 112; a higher scores mean a worse outcome.

  4. Self-Rating Anxiety Scale score,(SAS score)

    Time frame: Baseline assessment

    the minimum value is 25,and maximum value is 100; a higher scores mean a worse outcome.

  5. Bristol Stool Form Scale score

    Time frame: Baseline assessment

    the minimum value is 1,and maximum value is 7; a higher scores mean a worse outcome.

  6. Body Mass Index

    Time frame: Baseline assessment

  7. Disease duration,(year)

    Time frame: Baseline assessment

  8. ARA change on DFG,(°)

    Time frame: Baseline assessment

    changes in anorectal angle during defecography

  9. Anal canal diameter on DFG,(mm)

    Time frame: Baseline assessment

    anal canal diameter during straining on DFG

  10. PRS on DFG

    Time frame: Baseline assessment

    Puborectalis syndrome indicated by the defecography diagnostic report.

  11. IRP on DFG

    Time frame: Baseline assessment

    Internal rectal prolapse indicated by the defecography diagnostic report.

  12. Rectocele on DFG

    Time frame: Baseline assessment

    Rectocele indicated by the defecography diagnostic report.

  13. Anal Resting Pressure,(mmHg)

    Time frame: Baseline assessment

    Anal Resting Pressure measured by High-resolution Anorectal Manometry

  14. Anal Squeeze Pressure,(mmHg)

    Time frame: Baseline assessment

    Anal Squeeze Pressure measured by High-resolution Anorectal Manometry

  15. Rectal propulsive pressure,(mmHg)

    Time frame: Baseline assessment

    Rectal propulsive pressure measured by High-resolution Anorectal Manometry

  16. Anal relaxation rate,(%)

    Time frame: Baseline assessment

    Anal relaxation rate measured by High-resolution Anorectal Manometry during defecation

  17. DD on HR-ARM

    Time frame: 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%.

  18. ARA change on TPUS,(°)

    Time frame: Baseline assessment

    changes in anorectal angle during evacuation measured by Transperineal Ultrasound

  19. Right PRM thickness change on TPUS,(mm)

    Time frame: Baseline assessment

    Changes in right puborectalis muscle thickness during defecation measured by Transperineal Ultrasound

  20. Left PRM thickness change on TPUS,(mm)

    Time frame: Baseline assessment

    Changes in left puborectalis muscle thickness during defecation measured by Transperineal Ultrasound

  21. PRS on TPUS

    Time frame: Baseline assessment

    Puborectalis syndrome(PRS) indicated by the transperineal ultrasound diagnostic report

Sponsors and collaborators

Lead sponsor

Third Military Medical University

Other

Registry information

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Jul 6, 2026
Registry last updated
Jul 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.