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

28. juni 2026 opdateret af: 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.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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.

Undersøgelsestype

Observationel

Tilmelding (Faktiske)

164

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Kina
    • Chongqing Municipality
      • Yuzhong, Chongqing Municipality, Kina, 400042
        • Army Medical Center (Daping Hospital)

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Barn
  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Prøveudtagningsmetode

Sandsynlighedsprøve

Studiebefolkning

patients with suspected PRS-related DD

Beskrivelse

Inclusion Criteria:

  1. Age ranges from 16 to 85 years old.
  2. 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.
  3. Participants should be able to understand and complete relevant questionnaires.
  4. Participants should be willing to follow the research protocol and sign the informed consent form.

Exclusion Criteria:

  1. Pregnant women and lactating women
  2. Suffering from gastrointestinal and other malignant tumors
  3. Suffering from diseases such as diabetes and Parkinson's disease
  4. Currently participating in other clinical trials

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Kohorter og interventioner

Gruppe / kohorte
Intervention / Behandling
patients with suspected PRS-related DD
Andet: Analysis of inter-group differences
Analysis of inter-group differences

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Rectal emptying rate，（%）
Tidsramme: 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

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Obstructed Defecation Syndrome score，（ODS score）
Tidsramme: 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)
Tidsramme: 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）
Tidsramme: 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）
Tidsramme: 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
Tidsramme: Baseline assessment
the minimum value is 1,and maximum value is 7; a higher scores mean a worse outcome.
Baseline assessment
Body Mass Index
Tidsramme: Baseline assessment
Baseline assessment
Disease duration,(year)
Tidsramme: Baseline assessment
Baseline assessment
ARA change on DFG，(°)
Tidsramme: Baseline assessment
changes in anorectal angle during defecography
Baseline assessment
Anal canal diameter on DFG，（mm）
Tidsramme: Baseline assessment
anal canal diameter during straining on DFG
Baseline assessment
PRS on DFG
Tidsramme: Baseline assessment
Puborectalis syndrome indicated by the defecography diagnostic report.
Baseline assessment
IRP on DFG
Tidsramme: Baseline assessment
Internal rectal prolapse indicated by the defecography diagnostic report.
Baseline assessment
Rectocele on DFG
Tidsramme: Baseline assessment
Rectocele indicated by the defecography diagnostic report.
Baseline assessment
Anal Resting Pressure，（mmHg）
Tidsramme: Baseline assessment
Anal Resting Pressure measured by High-resolution Anorectal Manometry
Baseline assessment
Anal Squeeze Pressure,(mmHg)
Tidsramme: Baseline assessment
Anal Squeeze Pressure measured by High-resolution Anorectal Manometry
Baseline assessment
Rectal propulsive pressure,(mmHg)
Tidsramme: Baseline assessment
Rectal propulsive pressure measured by High-resolution Anorectal Manometry
Baseline assessment
Anal relaxation rate,(%)
Tidsramme: Baseline assessment
Anal relaxation rate measured by High-resolution Anorectal Manometry during defecation
Baseline assessment
DD on HR-ARM
Tidsramme: 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,(°)
Tidsramme: Baseline assessment
changes in anorectal angle during evacuation measured by Transperineal Ultrasound
Baseline assessment
Right PRM thickness change on TPUS,(mm)
Tidsramme: Baseline assessment
Changes in right puborectalis muscle thickness during defecation measured by Transperineal Ultrasound
Baseline assessment
Left PRM thickness change on TPUS,(mm)
Tidsramme: Baseline assessment
Changes in left puborectalis muscle thickness during defecation measured by Transperineal Ultrasound
Baseline assessment
PRS on TPUS
Tidsramme: Baseline assessment
Puborectalis syndrome(PRS) indicated by the transperineal ultrasound diagnostic report
Baseline assessment

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Third Military Medical University

Efterforskere

  • Studieleder: Weidong Tong, MD, Army Medical Center (Daping Hospital)

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

21. juli 2023

Primær færdiggørelse (Faktiske)

31. maj 2026

Studieafslutning (Faktiske)

31. maj 2026

Datoer for studieregistrering

Først indsendt

16. juni 2026

Først indsendt, der opfyldte QC-kriterier

28. juni 2026

Først opslået (Faktiske)

6. juli 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

6. juli 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

28. juni 2026

Sidst verificeret

1. juli 2023

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Andre undersøgelses-id-numre

  • PRS202409

Plan for individuelle deltagerdata (IPD)

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INGEN

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Kliniske forsøg med Dyssynergisk afføring

Kliniske forsøg med Analysis of inter-group differences

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