To investigate if the pre- and/or postoperative 3D-HRAM and 3 dimensional endo-anal ultrasound (3D-EAUS) might be a predictor for fecal incontinence after fistulotomy by evaluating changes in anorectal function and correlate this with the Fecal…
ID
Source
Brief title
Condition
- Procedural related injuries and complications NEC
- Gastrointestinal therapeutic procedures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
1. Changes in anorectal function measured with 3D-HRAM before and after
fistulotomy
2. Changes in continence and soiling between preoperative and 4 and 12 months
postoperative. Measured with patient reported outcome measurements: FiQL,
Wexner and ProctoPROM.
3. Correlation between 1 and 2
Secondary outcome
1. To analyze sphincter defects with the EAUS examination and correlate this
with the pressure-profile measured by 3D-HRAM.
2. To establish possible prognostic factors for deterioration in anorectal
function and fecal incontinence in patients who underwent fistulotomy
Background summary
The surgical management of anal fistulae remains challenging as consequences of
anal surgery can cause profound fecal incontinence (FI) and impair experienced
quality of life. Therefore fistulotomy is restricted to low fistulas. But even
then, FI may occur. Prospective conventional anorectal manometrie (ARM) studies
report that many fistula operations negatively influence anal pressures. With
advanced 3D-High resolution ARM (3D-HRAM), a three dimensional pressure profile
can be obtained.
Study objective
To investigate if the pre- and/or postoperative 3D-HRAM and 3 dimensional
endo-anal ultrasound (3D-EAUS) might be a predictor for fecal incontinence
after fistulotomy by evaluating changes in anorectal function and correlate
this with the Fecal Incontinence Quality of Life Scale at 4 and 12 months.
Study design
All patients who visit our clinics with a anal fistula who will undergo
fistulotomy will be asked to participate. Patients will be asked to fill in
questionnaires concerning anorectal function and quality of life (Wexner, FiQL,
ProctoPROM, VAS score and fistula complaints). Digital rectal examination,
3D-EAUS and 3D-HRAM will be performed pre- and postoperative.
Study burden and risks
30 min extra time during 4 months FU bezoek, 3x 5 min for questionnaires= 15 min
There is no further risk.
prof Bronkhorstlaan 10
Bilthoven 3723MB
NL
prof Bronkhorstlaan 10
Bilthoven 3723MB
NL
Listed location countries
Age
Inclusion criteria
- Age between 18-80 years
- Planned to undergo fistulotomy
- Suitable for e-mail questionnaires
- Sufficient understanding of the Dutch written language (reading and writing)
- Obtained written informed consent
Exclusion criteria
- Non cryptoglandular fistulae (Crohn*s disease e.a.)
- Prior rectal radiation
- Rectovaginal fistulae
- ASA 3-4 (patients who cannot undergo surgery in our clinic)
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 | NL78713.018.21 |