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ABS; transvaginal vs peri-anal approach.


- candidate number3038
- NTR NumberNTR1221
- ISRCTNISRCTN wordt niet meer aangevraagd
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR28-feb-2008
- Secondary IDs 
- Public TitleABS; transvaginal vs peri-anal approach.
- Scientific TitleArtificial Bowel Sphincter implantation; transvaginal versus peri-anal approach.
- ACRONYMABS
- hypothesisTransvaginal implantation of ABS system reduces the risk of infection.
- Healt Condition(s) or Problem(s) studiedFecal incontinence, Artificial Bowel Sphincter implantation
- Inclusion criteria1. Females
2. Informed consent
3. Older than 18 years
4. On the waiting list for ABS implantation.
- Exclusion criteria1. Males
2. ABS revision
3. New ABS implantation after prior explantation due to infection.
- mec approval receivedno
- multicenter trialno
- randomisedyes
- masking/blindingNone
- controlActive
- group[default]
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-mrt-2008
- planned closingdate1-mrt-2013
- Target number of participants70
- Interventions1. Artificial bowel sphincter system;
2. implantation.
- Primary outcomeInfection.
- Secondary outcome1. Quality of life;
2. Incontinence scores.
- TimepointsPreoperative 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.
- Trial web siteN/A
- statusstopped
- CONTACT FOR PUBLIC QUERIESProf. dr. J.T. Dissel, van
- CONTACT for SCIENTIFIC QUERIESProf Dr. C.G.M.I. Baeten
- Sponsor/Initiator University Hospital Maastricht (AZM)
- Funding
(Source(s) of Monetary or Material Support)
University Hospital Maastricht (AZM)
- PublicationsAll results will be published. No publications yet.
- Brief summaryRandomised 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.
- Main changes (audit trail)
- RECORD30-jan-2008 - 4-jun-2008


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