No registrations found.
ID
Source
Brief title
Health condition
Faecal incontinence.
Sponsors and support
Intervention
Outcome measures
Primary outcome
Infection.
Secondary outcome
1. Quality of life;
2. Incontinence scores.
Background summary
Randomised trial to compare infection rate in two surgical techniques to implant an Artificial Bowel Sphincter. We compare the peri-anal incision vs the transvaginal incision.
Study objective
Transvaginal implantation of ABS system reduces the risk of infection.
Study design
Preoperative quality of life and incontinence score assessment. 3 months after operation postoperative quality of life and incontinence score assessment.
Infection in 6 weeks after surgery.
Intervention
1. Artificial bowel sphincter system;
2. implantation.
Postbus 9600
J.T. Dissel, van
Leids Universitair Medisch Centrum
Afdeling Infectieziekten, C5P
Leiden 2300 RC
The Netherlands
+31715262613
j.t.van_dissel@lumc.nl
Postbus 9600
J.T. Dissel, van
Leids Universitair Medisch Centrum
Afdeling Infectieziekten, C5P
Leiden 2300 RC
The Netherlands
+31715262613
j.t.van_dissel@lumc.nl
Inclusion criteria
1. Females
2. Informed consent
3. Older than 18 years
4. On the waiting list for ABS implantation.
Exclusion criteria
1. Males
2. ABS revision
3. New ABS implantation after prior explantation due to infection.
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 |
|---|---|
| NTR-new | NL1176 |
| NTR-old | NTR1221 |
| Other | : |
| ISRCTN | ISRCTN wordt niet meer aangevraagd |