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Obstructed Defaecation: Proctography Versus Ultrasound in Symptomatic Patients (OPUS)

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ClinicalTrials.gov Identifier: NCT02239302
Recruitment Status : Completed
First Posted : September 12, 2014
Last Update Posted : July 31, 2015
Sponsor:
Information provided by (Responsible Party):
Ranee Thakar, Croydon University Hospital

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.


Condition or disease
Obstructed Defaecation Syndrome

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Study Type : Observational
Actual Enrollment : 131 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Obstructed Defaecation: Proctography Versus Ultrasound (TPUS and EVUS) in Symptomatic Patients
Study Start Date : January 2014
Actual Primary Completion Date : March 2015
Actual Study Completion Date : March 2015

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. 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 [ Time Frame: up to 3 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Female patients with symptomes of obstructed defaecation
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02239302


Locations
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United Kingdom
Croydon University Hospital
Croydon, Surrey, United Kingdom, CR7 7YE
Sponsors and Collaborators
Croydon University Hospital
Investigators
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Principal Investigator: Ranee Thakar, FRCOG Croydon University Hospital

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Ranee Thakar, Consultant Urogynaecologist, Croydon University Hospital
ClinicalTrials.gov Identifier: NCT02239302     History of Changes
Other Study ID Numbers: 13/LO/1665
First Posted: September 12, 2014    Key Record Dates
Last Update Posted: July 31, 2015
Last Verified: July 2015

Keywords provided by Ranee Thakar, Croydon University Hospital:
Obstructed defaecation syndrome
Transperineal Ultrasound
Endovaginal Ultrasound
Evacuation Proctography