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Psychiatric Disorder in Anorectal Dyssynergia

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ClinicalTrials.gov Identifier: NCT06128031
Recruitment Status : Not yet recruiting
First Posted : November 13, 2023
Last Update Posted : November 13, 2023
Sponsor:
Information provided by (Responsible Party):
Dina Medhat Hussein, Assiut University

Study Description
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Brief Summary:
  1. evaluate psychiatric disorders among patients with anorectal dyssynergia
  2. evaluate the effect of delayed diagnosis of anorectal dyssynergia on the quality of the life

Condition or disease Intervention/treatment
Anorectal Disorder Psychiatric Disorder Other: questionaire

Detailed Description:

Functional constipation is a functional bowel disorder that presents as persistently difficult, infrequent, or seemingly incomplete defecation.

Subjective and objective definitions of constipation include:

(1) straining, hard stools (hard, inspissated stool), unproductive calls ("want to but cannot"), infrequent stools, or incomplete evacuation. (2) <3 bowel movements per week, daily stool weight <35 g/day, or straining >25% of the time Dyssynergia defecation is common and affects up to one half of patients with chronic constipation. This acquired behavioral problem is due to the inability to coordinate the abdominal and pelvic floor muscles to evacuate stool The etiology of dyssynergic defecation is unclear however it was found that the problem began during childhood in 31% of patients, and after a particular event, such as pregnancy, trauma, or back injury in 29% of patients, and there was no cause in 40% of patients.

The first step in making a diagnosis of dyssynergic defecation is to exclude an underlying metabolic or pathologic disorder .A detailed history, prospective stool diaries, and a careful digital rectal examination will not only identify the nature of bowel dysfunction, but also raise the index of suspicion for this evacuation disorder. Anorectal physiology tests and balloon expulsion test are essential for a diagnosis. Newer techniques such as high-resolution manometry and magnetic resonance defecography can provide mechanistic insights.

. anorectal dyssynergia impact quality of life and cause psychiatric problems such as of anxiety, depression, obsessive compulsiveness, psychoticism, and somatization.

So, the investigators aim to evaluate psychiatric disorders among those patients and impact of delayed diagnosis on their quality of life.

Study Design
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Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Case-Control
Time Perspective: Retrospective
Official Title: Psychiatric Assessment of Patients With Anorectal Dyssynergia and the Impact on the Quality of Life
Estimated Study Start Date : November 1, 2023
Estimated Primary Completion Date : September 1, 2025
Estimated Study Completion Date : September 2025

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Intervention Details:
  • Other: questionaire

    Psychiatric interview: this will be assessed by (SCID-5)semi structural clinical interview based on Diagnostic and Statistical manual of Mental disorders-5 criteria

    -Psychometric assessment include; Hamilton depression rating scale(7) and Hamilton anxiety rating scale(8) , used to score the symptoms of anxiety or depression Quality of life assessment: will be assessed by the Patient assessment of constipation-quality of life questionnaire


Outcome Measures
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Primary Outcome Measures :
  1. 1-Assess psychiatric disorders among patients with anorectal dyssynergia [ Time Frame: through study completion, an average of 1 year ]
    Review the different types of psychiatric disorders in patients have diagnosed anorectal dyssynergia using SCID-5 ,anxiety and depression Hamilton score (from 0-4,zero refer to no symptoms ,4 refer to sever symptoms ), the summation of them show the type and severity of the condition


Secondary Outcome Measures :
  1. The impact of anorectal dyssynergia on the quality of the life [ Time Frame: Through study completion, an average of 1 year ]
    By using survey contain 36 short question about the quality of the life of the patient with anorectal dyssynergia and compare the answer with those of normal people


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Sampling Method:   Non-Probability Sample
Study Population
all population from 18 years which suffer from chronic conistipation and diagnosed anorectal dyssynergia by rectal manometry or defecogram
Criteria

Inclusion Criteria:

  • patients diagnosed as anorectal dyssynergia with anorectal manometric study

Exclusion Criteria:

  • patient with diabetes mellitus ,hypertension ,chronic kidney disease ,and chronic liver disease patients
  • patient with neurological disease
  • patient with thyroid disease
  • patient with past history of psychiatric disorders
  • patients with past or current medications or substance induced psychiatric disorders
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT06128031


Contacts
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Contact: Dina M Hussein, resident 01016434312 dinamedhat772@gmail.com
Contact: zain Elabdeen Ahmed, prof 0111559682 drzain73@yahoo.com

Sponsors and Collaborators
Assiut University
Investigators
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Study Director: Bahaa osman, teacher Assiut University
More Information
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Publications:

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Responsible Party: Dina Medhat Hussein, Principal Investigator, Assiut University
ClinicalTrials.gov Identifier: NCT06128031    
Other Study ID Numbers: psycosis&anorectal dyssynergia
First Posted: November 13, 2023    Key Record Dates
Last Update Posted: November 13, 2023
Last Verified: November 2023

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Rectal Diseases
Ataxia
Mental Disorders
Problem Behavior
Behavioral Symptoms
Dyskinesias
 Neurologic Manifestations
Nervous System Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases