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Completed

NCT Number: NCT02239302

Obstructed Defaecation: Proctography Versus Ultrasound in Symptomatic Patients

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.

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Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Croydon University Hospital

Croydon, Surrey, CR7 7YE, United Kingdom

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  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

Sponsors and collaborators

Lead sponsor

Croydon University Hospital

Other

Registry information

Official study title

Obstructed Defaecation: Proctography Versus Ultrasound (TPUS and EVUS) in Symptomatic Patients

Acronym: OPUS

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Sep 12, 2014
Registry last updated
Jul 31, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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