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 oppdatert av: 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.
Studieoversikt
Status
Fullført
Intervensjon / Behandling
Detaljert 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.
Studietype
Observasjonsmessig
Registrering (Faktiske)
164
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
-
-
Chongqing Municipality
-
Yuzhong, Chongqing Municipality, Kina, 400042
- Army Medical Center (Daping Hospital)
-
-
Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Barn
- Voksen
- Eldre voksen
Tar imot friske frivillige
Nei
Prøvetakingsmetode
Sannsynlighetsprøve
Studiepopulasjon
patients with suspected PRS-related DD
Beskrivelse
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
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
Kohorter og intervensjoner
Gruppe / Kohort |
Intervensjon / Behandling |
|---|---|
|
patients with suspected PRS-related DD
|
Analysis of inter-group differences
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
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 |
Tiltaksbeskrivelse |
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
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Etterforskere
- Studieleder: Weidong Tong, MD, Army Medical Center (Daping Hospital)
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Faktiske)
21. juli 2023
Primær fullføring (Faktiske)
31. mai 2026
Studiet fullført (Faktiske)
31. mai 2026
Datoer for studieregistrering
Først innsendt
16. juni 2026
Først innsendt som oppfylte QC-kriteriene
28. juni 2026
Først lagt ut (Faktiske)
6. juli 2026
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
6. juli 2026
Siste oppdatering sendt inn som oppfylte QC-kriteriene
28. juni 2026
Sist bekreftet
1. juli 2023
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Andre studie-ID-numre
- PRS202409
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
NEI
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Nei
Studerer et amerikansk FDA-regulert enhetsprodukt
Nei
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .