Obstructed Defaecation Syndrome Clinical Trial
— OPUSOfficial title:
Obstructed Defaecation: Proctography Versus Ultrasound (TPUS and EVUS) in Symptomatic Patients
| Verified date | July 2015 |
| Source | Croydon University Hospital |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | United Kingdom: Research Ethics Committee |
| Study type | Observational |
Obstructed defaecation syndrome is a common problem in which patients experience difficulty
to evacuate stools and feel that the bowel is incompletely empty, which causes the need to
put fingers in to the rectum or vaginal to empty the rectum. These symptoms have a
significant effect on social, physical, emotional and sexual wellbeing all of which have
impact on quality of life. These symptoms are caused by posterior compartment disorders such
as the last part of the large bowel bulging into the vagina (rectocele), the small bowel
pressing on the rectum (enterocele), a circumferential infolding of the rectal wall
(intussusception) or paradoxical pelvic floor contraction during attempts to evacuate
(anismus).
Currently the evacuation proctogram is the gold standard for diagnosis of posterior
compartment disorders. This technique, however, exposes the patient to ionising radiation,
requires preparation of the small and large bowel with contrast and defaecation in a
non-private setting, which most women find embarrassing and unpleasant. Over the years,
research has focussed on identifying alternatives that are better tolerated to substitute
evacuation proctography. Ultrasound is a widely available, non-expensive, non-invasive, fast
and a well-tolerated method for the dynamic and static imaging of the pelvic floor without
the use of ionising radiation. The level of agreement between transperineal ultrasound
(TPUS) and proctography for varies widely. Endovaginal ultrasound (EVUS) not yet compared to
proctography. The aim of this study is to assess the level of agreement between ultrasound
(EVUS and TPUS) and evacuation proctography in the diagnosis of posterior compartment
disorders.
| Status | Completed |
| Enrollment | 131 |
| Est. completion date | March 2015 |
| Est. primary completion date | March 2015 |
| Accepts healthy volunteers | No |
| Gender | Female |
| Age group | 18 Years and older |
| Eligibility |
Inclusion Criteria: - Female patients - Symptoms of obstructed defaecation - Planned for evacuation proctography Exclusion Criteria: - Inability to understand English - Unwilling to consent for evacuation proctography - Under 18 years of age - Virgo intacta |
Observational Model: Cohort, Time Perspective: Prospective
| Country | Name | City | State |
|---|---|---|---|
| United Kingdom | Croydon University Hospital | Croydon | Surrey |
| Lead Sponsor | Collaborator |
|---|---|
| Croydon University Hospital |
United Kingdom,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | The primary objective is to assess the level of agreement between ultrasound (EVUS and TPUS) and evacuation proctography in the diagnosis of posterior compartment disorders | up to 3 months | No |