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 bijgewerkt door: 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.
Studie Overzicht
Toestand
Voltooid
Interventie / Behandeling
Gedetailleerde beschrijving
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
Observationeel
Inschrijving (Werkelijk)
164
Contacten en locaties
In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.
Studie Locaties
-
-
Chongqing Municipality
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Yuzhong, Chongqing Municipality, China, 400042
- Army Medical Center (Daping Hospital)
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Deelname Criteria
Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
- Kind
- Volwassen
- Oudere volwassene
Accepteert gezonde vrijwilligers
Nee
Bemonsteringsmethode
Kanssteekproef
Studie Bevolking
patients with suspected PRS-related DD
Beschrijving
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
Studie plan
Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.
Hoe is de studie opgezet?
Ontwerpdetails
Cohorten en interventies
Groep / Cohort |
Interventie / Behandeling |
|---|---|
|
patients with suspected PRS-related DD
|
Analysis of inter-group differences
|
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Rectal emptying rate，（%）
Tijdsspanne: 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
|
Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Obstructed Defecation Syndrome score，（ODS score）
Tijdsspanne: 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)
Tijdsspanne: 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）
Tijdsspanne: 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）
Tijdsspanne: 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
Tijdsspanne: Baseline assessment
|
the minimum value is 1,and maximum value is 7; a higher scores mean a worse outcome.
|
Baseline assessment
|
|
Body Mass Index
Tijdsspanne: Baseline assessment
|
Baseline assessment
|
|
|
Disease duration,(year)
Tijdsspanne: Baseline assessment
|
Baseline assessment
|
|
|
ARA change on DFG，(°)
Tijdsspanne: Baseline assessment
|
changes in anorectal angle during defecography
|
Baseline assessment
|
|
Anal canal diameter on DFG，（mm）
Tijdsspanne: Baseline assessment
|
anal canal diameter during straining on DFG
|
Baseline assessment
|
|
PRS on DFG
Tijdsspanne: Baseline assessment
|
Puborectalis syndrome indicated by the defecography diagnostic report.
|
Baseline assessment
|
|
IRP on DFG
Tijdsspanne: Baseline assessment
|
Internal rectal prolapse indicated by the defecography diagnostic report.
|
Baseline assessment
|
|
Rectocele on DFG
Tijdsspanne: Baseline assessment
|
Rectocele indicated by the defecography diagnostic report.
|
Baseline assessment
|
|
Anal Resting Pressure，（mmHg）
Tijdsspanne: Baseline assessment
|
Anal Resting Pressure measured by High-resolution Anorectal Manometry
|
Baseline assessment
|
|
Anal Squeeze Pressure,(mmHg)
Tijdsspanne: Baseline assessment
|
Anal Squeeze Pressure measured by High-resolution Anorectal Manometry
|
Baseline assessment
|
|
Rectal propulsive pressure,(mmHg)
Tijdsspanne: Baseline assessment
|
Rectal propulsive pressure measured by High-resolution Anorectal Manometry
|
Baseline assessment
|
|
Anal relaxation rate,(%)
Tijdsspanne: Baseline assessment
|
Anal relaxation rate measured by High-resolution Anorectal Manometry during defecation
|
Baseline assessment
|
|
DD on HR-ARM
Tijdsspanne: 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,(°)
Tijdsspanne: Baseline assessment
|
changes in anorectal angle during evacuation measured by Transperineal Ultrasound
|
Baseline assessment
|
|
Right PRM thickness change on TPUS,(mm)
Tijdsspanne: Baseline assessment
|
Changes in right puborectalis muscle thickness during defecation measured by Transperineal Ultrasound
|
Baseline assessment
|
|
Left PRM thickness change on TPUS,(mm)
Tijdsspanne: Baseline assessment
|
Changes in left puborectalis muscle thickness during defecation measured by Transperineal Ultrasound
|
Baseline assessment
|
|
PRS on TPUS
Tijdsspanne: Baseline assessment
|
Puborectalis syndrome(PRS) indicated by the transperineal ultrasound diagnostic report
|
Baseline assessment
|
Medewerkers en onderzoekers
Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.
Onderzoekers
- Studie directeur: Weidong Tong, MD, Army Medical Center (Daping Hospital)
Studie record data
Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.
Bestudeer belangrijke data
Studie start (Werkelijk)
21 juli 2023
Primaire voltooiing (Werkelijk)
31 mei 2026
Studie voltooiing (Werkelijk)
31 mei 2026
Studieregistratiedata
Eerst ingediend
16 juni 2026
Eerst ingediend dat voldeed aan de QC-criteria
28 juni 2026
Eerst geplaatst (Werkelijk)
6 juli 2026
Updates van studierecords
Laatste update geplaatst (Werkelijk)
6 juli 2026
Laatste update ingediend die voldeed aan QC-criteria
28 juni 2026
Laatst geverifieerd
1 juli 2023
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Andere studie-ID-nummers
- PRS202409
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
NEE
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Nee
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
Nee
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