Clinical trial NCT02239302: Obstructed Defaecation: Proctography Versus Ultrasound in Symptomatic Patients
Official title: Obstructed Defaecation: Proctography Versus Ultrasound (TPUS and EVUS) in Symptomatic Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Obstructed Defaecation Syndrome
Keywords: Obstructed defaecation syndrome
Transperineal Ultrasound
Endovaginal Ultrasound
Evacuation Proctography
Lead sponsor: Croydon University Hospital
Sponsor class: OTHER
First posted: 2014-09-12
Enrollment: 131
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Female patients with symptomes of obstructed defaecation

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: 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
timeFrame: up to 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Croydon
country: United Kingdom
facility: Croydon University Hospital
state: Surrey
Study officials:
affiliation: Croydon University Hospital
name: Ranee Thakar, FRCOG
role: PRINCIPAL_INVESTIGATOR
References:
citation: van Gruting IMA, Stankiewicz A, Kluivers K, De Bin R, Blake H, Sultan AH, Thakar R. Accuracy of Four Imaging Techniques for Diagnosis of Posterior Pelvic Floor Disorders. Obstet Gynecol. 2017 Nov;130(5):1017-1024. doi: 10.1097/AOG.0000000000002245.