NCT06128031

Brief Summary

  1. 1.evaluate psychiatric disorders among patients with anorectal dyssynergia
  2. 2.evaluate the effect of delayed diagnosis of anorectal dyssynergia on the quality of the life

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Nov 2023

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 21, 2023

Completed
2 months until next milestone

Study Start

First participant enrolled

November 1, 2023

Completed
12 days until next milestone

First Posted

Study publicly available on registry

November 13, 2023

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2025

Completed
Last Updated

November 13, 2023

Status Verified

November 1, 2023

Enrollment Period

1.8 years

First QC Date

August 21, 2023

Last Update Submit

November 9, 2023

Conditions

Anorectal DisorderPsychiatric Disorder

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • The impact of anorectal dyssynergia on the quality of the life

    Through study completion, an average of 1 year

Interventions

questionaireOTHER

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

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

all population from 18 years which suffer from chronic conistipation and diagnosed anorectal dyssynergia by rectal manometry or defecogram

You may qualify if:

  • patients diagnosed as anorectal dyssynergia with anorectal manometric study

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (7)

  • 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.

    PMID: 16678561BACKGROUND

  • 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.

    PMID: 15500515BACKGROUND

  • 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.

    PMID: 15319652BACKGROUND

  • 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.

    PMID: 17905054BACKGROUND

  • 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.

    PMID: 11413563BACKGROUND

  • 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.

    PMID: 3395203BACKGROUND

  • 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.

    PMID: 24834176BACKGROUND

MeSH Terms

Conditions

Rectal DiseasesMental Disorders

Condition Hierarchy (Ancestors)

Intestinal DiseasesGastrointestinal DiseasesDigestive System Diseases

Study Officials

  • Bahaa osman, teacher

    Assiut University

    STUDY DIRECTOR

Central Study Contacts

Dina M Hussein, resident

CONTACT

01016434312dinamedhat772@gmail.com

zain Elabdeen Ahmed, prof

CONTACT

0111559682drzain73@yahoo.com

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

August 21, 2023

First Posted

November 13, 2023

Study Start

November 1, 2023

Primary Completion

September 1, 2025

Study Completion

September 1, 2025

Last Updated

November 13, 2023

Record last verified: 2023-11