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CompletedNCT02239302OPUSUpdated Jul 31, 2015

Obstructed Defaecation: Proctography Versus Ultrasound in Symptomatic Patients

An observational study in Obstructed Defaecation Syndrome, sponsored by Croydon University Hospital. Completed at 1 site in United Kingdom. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2015-07-31.

Sponsored by Croydon University Hospital · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
131
Ages
18 Years and older
Sex
Female
01

Study 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.

02

Conditions studied

  • Obstructed Defaecation Syndrome

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Keywords

  • Obstructed defaecation syndrome
  • Transperineal Ultrasound
  • Endovaginal Ultrasound
  • Evacuation Proctography
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In context

Syndrome

9,217 studies on the registry are indexed under Syndrome; 1,031 are open to participants now.

This study's enrollment of 131 is above the median of 102 across 2,209 observational studies indexed under Syndrome.

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Lead sponsor

Croydon University Hospital is the lead sponsor of 5 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
Female
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Female patients with symptomes of obstructed defaecation

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • Inability to understand English
  • Unwilling to consent for evacuation proctography
  • Under 18 years of age
  • Virgo intacta
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
131 participants (actual)
Patient registry
No
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What researchers measure

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

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Study locations

1 site
  • Croydon University Hospital
    Croydon, Surrey CR7 7YE, United Kingdom
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References and documents

Publications

  • 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. PubMed 29016504 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 31, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02239302
Lead sponsor
Croydon University Hospital
Responsible party
Ranee Thakar (Consultant Urogynaecologist, Croydon University Hospital) — Principal investigator
First posted
Sep 12, 2014
Start date
Jan 2014
Primary completion
Mar 2015
Completion
Mar 2015
Last update
Jul 31, 2015

Study contacts

Ranee Thakar, FRCOG
principal investigator · Croydon University Hospital

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2015. You cannot join it, but the record below documents what was studied.

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