Denna sida har översatts automatiskt och översättningens korrekthet kan inte garanteras. Vänligen se engelsk version för en källtext.

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 uppdaterad 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.

Studieöversikt

Status

Avslutad

Betingelser

Intervention / Behandling

Detaljerad beskrivning

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.

Studietyp

Observationell

Inskrivning (Faktisk)

164

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studieorter

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

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

  • Barn
  • Vuxen
  • Äldre vuxen

Tar emot friska volontärer

Nej

Testmetod

Sannolikhetsprov

Studera befolkning

patients with suspected PRS-related DD

Beskrivning

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

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

Kohorter och interventioner

Grupp / Kohort
Intervention / Behandling
patients with suspected PRS-related DD
Övrig: Analysis of inter-group differences
Analysis of inter-group differences

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Rectal emptying rate，（%）
Tidsram: 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

Sekundära resultatmått

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

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

Third Military Medical University

Utredare

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

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Faktisk)

21 juli 2023

Primärt slutförande (Faktisk)

31 maj 2026

Avslutad studie (Faktisk)

31 maj 2026

Studieregistreringsdatum

Först inskickad

16 juni 2026

Först inskickad som uppfyllde QC-kriterierna

28 juni 2026

Första postat (Faktisk)

6 juli 2026

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

6 juli 2026

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

28 juni 2026

Senast verifierad

1 juli 2023

Mer information

Termer relaterade till denna studie

Nyckelord

Andra studie-ID-nummer

  • PRS202409

Plan för individuella deltagardata (IPD)

Planerar du att dela individuella deltagardata (IPD)?

NEJ

Läkemedels- och apparatinformation, studiedokument

Studerar en amerikansk FDA-reglerad läkemedelsprodukt

Nej

Studerar en amerikansk FDA-reglerad produktprodukt

Nej

Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .

Prenumerera