- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT06128031
Psychiatric Disorder in Dysnergic Defecation
Psychiatric Assessment of Patients With Dyssynergic Defecation and Its Impact on Their Quality of Life
Case control observational study conducted on DD patient and healthy control group.
- evaluate psychiatric disorders among patients with dyssynergic defecation
- evaluate the effect of delayed diagnosis of dysnergic defecation on the quality of the life
Studieoversikt
Status
Intervensjon / Behandling
Detaljert beskrivelse
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.
Studietype
Registrering (Faktiske)
Kontakter og plasseringer
Studiesteder
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Asyut, Egypt
- Git center
-
-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Barn
- Voksen
- Eldre voksen
Tar imot friske frivillige
Prøvetakingsmetode
Studiepopulasjon
Beskrivelse
Inclusion Criteria:
- patients diagnosed as 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
Studieplan
Hvordan er studiet utformet?
Designdetaljer
Kohorter og intervensjoner
Gruppe / Kohort |
Intervensjon / Behandling |
|---|---|
|
Dysnergic defecation disease group
Healthy control population
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No intervention,only observation case control study
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
1-Assess psychiatric disorders among patients with dyssynergic defecation
Tidsramme: through study completion, an average of 1 year
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Review the different types of psychiatric disorders in patients have diagnosed DD 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
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through study completion, an average of 1 year
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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
The impact of dyssynergia defecation on the quality of the life
Tidsramme: 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 dyssynergia defecation and compare the answer with those of normal people
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Through study completion, an average of 1 year
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Samarbeidspartnere og etterforskere
Sponsor
Etterforskere
- Studieleder: Bahaa osman, teacher, Assiut University
Publikasjoner og nyttige lenker
Generelle publikasjoner
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- psycosis&dyssynergic defecatio
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Studerer et amerikansk FDA-regulert enhetsprodukt
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