Obstructed Defaecation: Proctography Versus Ultrasound in Symptomatic Patients

NCT02239302 | Completed DMC

• 1 other identifier: 13/LO/1665
• Study Type: observational
• Target: 131
• Locations: 1 country
• Sites: 1

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.

Conditions

Obstructed Defaecation Syndrome

Keywords

Obstructed defaecation syndrome; Transperineal Ultrasound; Endovaginal Ultrasound; Evacuation Proctography

Outcome Measures

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

  up to 3 months

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Female patients with symptomes of obstructed defaecation

You may qualify if:

• Female patients
• Symptoms of obstructed defaecation
• Planned for evacuation proctography

You may not qualify if:

• Inability to understand English
• Unwilling to consent for evacuation proctography
• Under 18 years of age
• Virgo intacta

Sponsors & Collaborators

• Croydon University Hospital: lead

Study Sites (1)

Croydon University Hospital

Croydon, Surrey, CR7 7YE, United Kingdom

Location

Related Publications (1)

• 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.

  PMID: 29016504 DERIVED

Study Officials

• Ranee Thakar, FRCOG

  Croydon University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Consultant Urogynaecologist

Study Record Dates

• First Submitted: September 10, 2014
• First Posted: September 12, 2014
• Study Start: January 1, 2014
• Primary Completion: March 1, 2015
• Study Completion: March 1, 2015
• Last Updated: July 31, 2015

Record last verified: 2015-07

Locations

GB (1)