Assessment and quantification of the function of the external anal sphincter by means of 4D ultrasound.
ID
Source
Brief title
Condition
- Other condition
- Pregnancy, labour, delivery and postpartum conditions
Synonym
Health condition
Sfincterletsel
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Primary outcome is to determine the added value of functional assessment of the
external anal sphincter by means of 4D ultrasound strain measurements in
diagnosis and treatment decision making for patients with anal sphincter
dysfunction and/or fecal incontinence.
Secondary outcome
Secondary outcomes include:
Relation between 4D ultrasound and other measurements
Differences in EAS function and anatomy between groups
Relation between physical complaints and the amount of anal trauma.
Background summary
Rationale:
Fecal incontinence (FI) is the involuntary discharge of liquid or solid stools.
The estimated prevalence of FI in noninstitutionalized US adults is 8.3%. FI
has a high impact on the quality of life. A 2009 cross-sectional study of 154
patients (27 male) with FI using the Fecal Incontinence Quality of Life Scale
reported that more than 22% of patients had their QoL affected severely (on a
scale of 1= very affected and 4 = not affected) by FI. The pelvic floor muscles
that maintain faecal continence are the internal anal sphincter (IAS), external
anal sphincter (EAS) and puborectalis muscle (PRM).
Main causes voor trauma, and therefore disfunction of the EAS is obstetric anal
sphincter injury (OASI) or surgical intervention due to (recurring) perianal
fistula.
Current assessment of the EAS is done by manometry, digitization or 2D/3D
ultrasound based on anatomical parameters.
Hypothesis: We hypothesize, that accurate diagnosis of (trauma to) the external
anal sphincter can be improved by means of 4D functional ultrasound
Study objective
Assessment and quantification of the function of the external anal sphincter by
means of 4D ultrasound.
Study design
prospective cross-sectional comparison study
Study burden and risks
We ask the volunteers and patients to visit the ZGT hospital at least one times
(in case of effectiveness of for instance pelvic therapy follow-up is
necessary).
During these visits of approximately 30 minutes, patients will undergo
transperineal ultrasound examination and fill in (homemade and dedicated
(PDFI-20)) questionnaires. The questionnaires do not relate to sexual wellbeing
and the ultrasound is non-invasive.
Geerdinksweg 141
Hengelo 7555DL
NL
Geerdinksweg 141
Hengelo 7555DL
NL
Listed location countries
Age
Inclusion criteria
o Good knowledge of Dutch language
o Women >=18 years of age
o Signed informed consent
Patients:
o Previous anal sphincter injury (OASI)
Additional inclusion criteria for each substudy will be described in the
appendices.
Exclusion criteria
We only list general exclusion criteria for the healthy controls, since patient
characteristics will be sub-study dependent.
• Known injury to the anal sphincter
• Symptoms of pelvic floor dysfunction (e.g. urinary of fecal incontinence,
obstipation, prolapse feeling, pelvic pain)
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL83010.091.22 |