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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06128031
Other study ID # psycosis&anorectal dyssynergia
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date November 1, 2023
Est. completion date September 2025

Study information

Verified date November 2023
Source Assiut University
Contact Dina M Hussein, resident
Phone 01016434312
Email dinamedhat772@gmail.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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


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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 100
Est. completion date September 2025
Est. primary completion date September 1, 2025
Accepts healthy volunteers
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Intervention

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

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Assiut University

References & Publications (7)

Hosseinzadeh ST, Poorsaadati S, Radkani B, Forootan M. Psychological disorders in patients with chronic constipation. Gastroenterol Hepatol Bed Bench. 2011 Summer;4(3):159-63. — View Citation

Longstreth GF, Thompson WG, Chey WD, Houghton LA, Mearin F, Spiller RC. Functional bowel disorders. Gastroenterology. 2006 Apr;130(5):1480-91. doi: 10.1053/j.gastro.2005.11.061. Erratum In: Gastroenterology. 2006 Aug;131(2):688. — View Citation

Rao SS, Mudipalli RS, Stessman M, Zimmerman B. Investigation of the utility of colorectal function tests and Rome II criteria in dyssynergic defecation (Anismus). Neurogastroenterol Motil. 2004 Oct;16(5):589-96. doi: 10.1111/j.1365-2982.2004.00526.x. — View Citation

Rao SS, Seaton K, Miller MJ, Schulze K, Brown CK, Paulson J, Zimmerman B. Psychological profiles and quality of life differ between patients with dyssynergia and those with slow transit constipation. J Psychosom Res. 2007 Oct;63(4):441-9. doi: 10.1016/j.jpsychores.2007.05.016. Epub 2007 Aug 1. — View Citation

Rao SS, Tuteja AK, Vellema T, Kempf J, Stessman M. Dyssynergic defecation: demographics, symptoms, stool patterns, and quality of life. J Clin Gastroenterol. 2004 Sep;38(8):680-5. doi: 10.1097/01.mcg.0000135929.78074.8c. — View Citation

Shear MK, Vander Bilt J, Rucci P, Endicott J, Lydiard B, Otto MW, Pollack MH, Chandler L, Williams J, Ali A, Frank DM. Reliability and validity of a structured interview guide for the Hamilton Anxiety Rating Scale (SIGH-A). Depress Anxiety. 2001;13(4):166-78. — View Citation

Williams JB. A structured interview guide for the Hamilton Depression Rating Scale. Arch Gen Psychiatry. 1988 Aug;45(8):742-7. doi: 10.1001/archpsyc.1988.01800320058007. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 1-Assess psychiatric disorders among patients with anorectal dyssynergia 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 through study completion, an average of 1 year
Secondary The impact of anorectal dyssynergia on the quality of the life 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 Through study completion, an average of 1 year
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