Psychiatric DisorderNCT06128031
Psychiatric Disorder in Dysnergic Defecation
An observational study of Psychiatric Disorder and Dysnergic Defecation, run by Assiut University at 1 site in Egypt.
Trial summary
Case control observational study conducted on DD patient and healthy control group. 1. evaluate psychiatric disorders among patients with dyssynergic defecation 2. evaluate the effect of delayed diagnosis of dysnergic defecation on the quality of the life Read more about this study
- Who is it for?
- Ages 15 years and olderHealthy volunteers can take part
- Conditions the study is for
- Psychiatric Disorder, Dysnergic Defecation
- How many people
- 148 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Nov 2023to 31 Jan 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Disease group suffer from chronic conistipation and diagnosed dyssynergic defecation
Who may be able to join
- patients diagnosed as dyssynergia with anorectal manometric study
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
Read the 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.
- Conditions
- Psychiatric Disorder, Dysnergic Defecation
- Being tested
- No intervention
- Medical subject headings
- Mental Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionOther
No intervention,only observation case control study
| Study group | Role | What they receive |
|---|---|---|
| Dysnergic defecation disease group | Healthy control population Receives: Other: No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
1-Assess psychiatric disorders among patients with dyssynergic defecation
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
Measured: through study completion, an average of 1 year
Secondary outcomes (1)
The impact of dyssynergia defecation on the quality of the life
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
Measured: Through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2023
- Study start1 Nov 2023
- Primary completion1 Sep 2025
- Study completion31 Jan 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Psychiatric DisorderStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 148 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dina Medhat Hussein, Assiut University
- Investigators
- Bahaa osman, teacher, Study director, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06128031
- Sponsor's protocol ID
- psycosis&dyssynergic defecatio
- Status last verified
- Jun 2026
- First submitted
- 21 Aug 2023
- Last updated
- 1 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 16678561Rao 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.
PubMed 15500515Rao 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.
PubMed 15319652Rao 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.
PubMed 17905054Shear 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.
PubMed 11413563Williams 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.
PubMed 3395203Hosseinzadeh ST, Poorsaadati S, Radkani B, Forootan M. Psychological disorders in patients with chronic constipation. Gastroenterol Hepatol Bed Bench. 2011 Summer;4(3):159-63.
PubMed 24834176
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Psychiatric Assessment of Patients With Dyssynergic Defecation and Its Impact on Their Quality of Life
- ClinicalTrials.gov ID
- NCT06128031
- Acronym / sponsor ID
- psycosis&dyssynergic defecatio
- Conditions
- Psychiatric Disorder, Dysnergic Defecation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 148 participants (actual)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Nov 2023 (actual)
- Primary completion
- 1 Sep 2025 (actual)
- Study completion
- 31 Jan 2026 (actual)
- First posted
- 13 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Dysnergic defecation disease group | – | Other: No interventionHealthy control population |
Who may qualify
- Ages
- 15 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Disease group suffer from chronic conistipation and diagnosed dyssynergic defecation
Key inclusion criteria (1 listed)
- patients diagnosed as dyssynergia with anorectal manometric study
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No interventionNo intervention,only observation case control study | Other | Dysnergic defecation disease group |
Primary outcome
1-Assess psychiatric disorders among patients with dyssynergic defecation
Time frame: through study completion, an average of 1 year
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
1 secondary outcome
The impact of dyssynergia defecation on the quality of the life
Time frame: Through study completion, an average of 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jul 2026.
- Background: PubMed 16678561Longstreth 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.
- Background: PubMed 15500515Rao 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.
- Background: PubMed 15319652Rao 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.
- Background: PubMed 17905054Rao 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.
- Background: PubMed 11413563Shear 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.
- Background: PubMed 3395203Williams 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.
- Background: PubMed 24834176Hosseinzadeh ST, Poorsaadati S, Radkani B, Forootan M. Psychological disorders in patients with chronic constipation. Gastroenterol Hepatol Bed Bench. 2011 Summer;4(3):159-63.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bahaa osman, teacher study director
Assiut University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Psychiatric Disorder and Dysnergic Defecation, run by Assiut University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
1-Assess psychiatric disorders among patients with dyssynergic defecation (time frame: through study completion, an average of 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06128031, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jul 2026.