Use of 3D Ultrasound to Predict Anal Sphincter Defects

NCT ID: NCT02655900

Last Updated: 2016-01-14

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 250 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2013-08-31
• Study Completion Date: 2015-08-31

Brief Summary

Injury to the muscles of the back passage (anal canal) is a relatively common problem. This injury can result in problems with bowel control later in life and usually occurs during vaginal childbirth (commonly referred to as 3rd and 4th degree perineal tears). Currently women who have sustained injury to the muscles of the back passage undergo an ultrasound scan by inserting a probe 3 to 4 cms into the back passage. This helps to check if the muscle of the back passage has healed i.e is intact or has a defect. The investigators would like to establish whether a 3D ultrasound scan probe placed outside the vagina can identify the defects and hence avoid inserting the probe into the back passage. In addition to getting the above information using 3D ultrasound scan, the investigators would also like to identify injuries to the pelvic floor muscle (levator ani) in these patients. Which can be diagnosed using the 3D ultrasound probe placed outside the vagina (perineum). Women who sustain injury to this muscle are known to develop prolapse later on in life.

Conditions

Obstetric Anal Sphincter Injury

Study Design

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

Interventions

Pelvic Floor Ultrasound

Transperineal Ultrasound (3D TPUS) and Endovaginal Ultrasound (3D EVUS)

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Women who sustained an obstetric anal sphincter injury referred to the perineal clinic

Exclusion Criteria

• None

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Croydon University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Ranee Thakar

Consultant Obstetrician and Urogynaecologist

Responsibility Role: PRINCIPAL_INVESTIGATOR

References

Taithongchai A, van Gruting IMA, Volloyhaug I, Arendsen LP, Sultan AH, Thakar R. Comparing the diagnostic accuracy of 3 ultrasound modalities for diagnosing obstetric anal sphincter injuries. Am J Obstet Gynecol. 2019 Aug;221(2):134.e1-134.e9. doi: 10.1016/j.ajog.2019.04.009. Epub 2019 Apr 11.

Reference Type: DERIVED

PMID: 30981717 (View on PubMed)

Other Identifiers

13/LO/0232

Identifier Type: -

Identifier Source: org_study_id