Obstructed Defaecation: Proctography Versus Ultrasound in Symptomatic Patients

NCT ID: NCT02239302

Last Updated: 2015-07-31

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 131 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2014-01-31
• Study Completion Date: 2015-03-31

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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Croydon University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Ranee Thakar

Consultant Urogynaecologist

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ranee Thakar, FRCOG

Role: PRINCIPAL_INVESTIGATOR

Croydon University Hospital

Locations

Croydon University Hospital

Croydon, Surrey, United Kingdom

Countries

United Kingdom

References

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.

Reference Type: DERIVED

PMID: 29016504 (View on PubMed)

Other Identifiers

13/LO/1665

Identifier Type: -

Identifier Source: org_study_id