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 aktualisiert von: 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.
Studienübersicht
Status
Abgeschlossen
Intervention / Behandlung
Detaillierte Beschreibung
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.
Studientyp
Beobachtungs
Einschreibung (Tatsächlich)
164
Kontakte und Standorte
Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.
Studienorte
-
-
Chongqing Municipality
-
Yuzhong, Chongqing Municipality, China, 400042
- Army Medical Center (Daping Hospital)
-
-
Teilnahmekriterien
Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.
Zulassungskriterien
Studienberechtigtes Alter
- Kind
- Erwachsene
- Älterer Erwachsener
Akzeptiert gesunde Freiwillige
Nein
Probenahmeverfahren
Wahrscheinlichkeitsstichprobe
Studienpopulation
patients with suspected PRS-related DD
Beschreibung
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
Studienplan
Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.
Wie ist die Studie aufgebaut?
Designdetails
Kohorten und Interventionen
Gruppe / Kohorte |
Intervention / Behandlung |
|---|---|
|
patients with suspected PRS-related DD
|
Analysis of inter-group differences
|
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Rectal emptying rate，（%）
Zeitfenster: 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
|
Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Obstructed Defecation Syndrome score，（ODS score）
Zeitfenster: 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)
Zeitfenster: 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）
Zeitfenster: 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）
Zeitfenster: 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
Zeitfenster: Baseline assessment
|
the minimum value is 1,and maximum value is 7; a higher scores mean a worse outcome.
|
Baseline assessment
|
|
Body Mass Index
Zeitfenster: Baseline assessment
|
Baseline assessment
|
|
|
Disease duration,(year)
Zeitfenster: Baseline assessment
|
Baseline assessment
|
|
|
ARA change on DFG，(°)
Zeitfenster: Baseline assessment
|
changes in anorectal angle during defecography
|
Baseline assessment
|
|
Anal canal diameter on DFG，（mm）
Zeitfenster: Baseline assessment
|
anal canal diameter during straining on DFG
|
Baseline assessment
|
|
PRS on DFG
Zeitfenster: Baseline assessment
|
Puborectalis syndrome indicated by the defecography diagnostic report.
|
Baseline assessment
|
|
IRP on DFG
Zeitfenster: Baseline assessment
|
Internal rectal prolapse indicated by the defecography diagnostic report.
|
Baseline assessment
|
|
Rectocele on DFG
Zeitfenster: Baseline assessment
|
Rectocele indicated by the defecography diagnostic report.
|
Baseline assessment
|
|
Anal Resting Pressure，（mmHg）
Zeitfenster: Baseline assessment
|
Anal Resting Pressure measured by High-resolution Anorectal Manometry
|
Baseline assessment
|
|
Anal Squeeze Pressure,(mmHg)
Zeitfenster: Baseline assessment
|
Anal Squeeze Pressure measured by High-resolution Anorectal Manometry
|
Baseline assessment
|
|
Rectal propulsive pressure,(mmHg)
Zeitfenster: Baseline assessment
|
Rectal propulsive pressure measured by High-resolution Anorectal Manometry
|
Baseline assessment
|
|
Anal relaxation rate,(%)
Zeitfenster: Baseline assessment
|
Anal relaxation rate measured by High-resolution Anorectal Manometry during defecation
|
Baseline assessment
|
|
DD on HR-ARM
Zeitfenster: 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,(°)
Zeitfenster: Baseline assessment
|
changes in anorectal angle during evacuation measured by Transperineal Ultrasound
|
Baseline assessment
|
|
Right PRM thickness change on TPUS,(mm)
Zeitfenster: Baseline assessment
|
Changes in right puborectalis muscle thickness during defecation measured by Transperineal Ultrasound
|
Baseline assessment
|
|
Left PRM thickness change on TPUS,(mm)
Zeitfenster: Baseline assessment
|
Changes in left puborectalis muscle thickness during defecation measured by Transperineal Ultrasound
|
Baseline assessment
|
|
PRS on TPUS
Zeitfenster: Baseline assessment
|
Puborectalis syndrome(PRS) indicated by the transperineal ultrasound diagnostic report
|
Baseline assessment
|
Mitarbeiter und Ermittler
Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.
Ermittler
- Studienleiter: Weidong Tong, MD, Army Medical Center (Daping Hospital)
Studienaufzeichnungsdaten
Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.
Haupttermine studieren
Studienbeginn (Tatsächlich)
21. Juli 2023
Primärer Abschluss (Tatsächlich)
31. Mai 2026
Studienabschluss (Tatsächlich)
31. Mai 2026
Studienanmeldedaten
Zuerst eingereicht
16. Juni 2026
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
28. Juni 2026
Zuerst gepostet (Tatsächlich)
6. Juli 2026
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
6. Juli 2026
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
28. Juni 2026
Zuletzt verifiziert
1. Juli 2023
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Andere Studien-ID-Nummern
- PRS202409
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Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
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