To evaluate the subjective and objective cure after surgical re-intervention due to mesh complications in our clinical setting in order to optimize therapy.
ID
Source
Brief title
Condition
- Obstetric and gynaecological therapeutic procedures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Subjective improvement at the study visit, measured by PGI-I.
Secondary outcome
- Disease specific quality of life at study visit.
- Re- interventions after the *mesh revision*
- Anatomical cure of prolapse, measured with POPQ
Background summary
Pelvic Organ Prolapse (POP) is a common condition amongst women worldwide with
a major impact on quality of life. Various operative procedures for POP exist,
however the perfect operation hasn*t been found. Many women suffer from
recurrence of prolapse and re-operation is common (29%). The high failure rates
of conventional surgery for POP led to innovation in pelvic floor surgery and
the introduction of the synthetic vaginal mesh system (TVM) in 2004. Here after
many mesh systems were developed and marketed. Clinical studies show that
restoration of anatomy with synthetic mesh is superior to conventional surgery,
however mesh surgery has its own mesh related complications.
The most common mesh-related complication is mesh exposure. It has been
described that approximately 10% of women operated with synthetic mesh
experienced mesh exposure within 12 months of surgery and more than half of
these women required surgical correction in the operating room. Furthermore
reports of pain associated with mesh shrinkage, causing vaginal shortening and
tightening and persistent pain despite mesh removal were found in literature.
In the Netherlands, the Academic Medical Center is a tertiary referral center
for mesh related complications. Between 2009 and 2014, fifty-six women
presented to our clinic, because of exposure of vaginal mesh or mesh-related
pain. These women have been managed surgically in our center. Either the
exposure was excised and closed, or mesh has been removed or cut to relieve
pain.
We plan to execute this study to measure the effectiveness of surgical mesh
revision in case of mesh related complications in order to optimize treatment.
Study objective
To evaluate the subjective and objective cure after surgical re-intervention
due to mesh complications in our clinical setting in order to optimize therapy.
Study design
A retrospective single-arm observational study in two Dutch teaching hospitals
with a special interest in uro-gynaecology.
Study burden and risks
Patients will be asked to visit our clinic. During this extra visit patients
will be asked to fill out validated questionairres. Furthermore a strutured
interview and a pelvic exam will be performed. The visit will take about 45
minutes.
Meibergdreef 9
Amsterdam 1105AZ
NL
Meibergdreef 9
Amsterdam 1105AZ
NL
Listed location countries
Age
Inclusion criteria
All patients that have been operated between 2009 and 2014 in the Academic Medical Center or Bergmanclinics Vrouwenzorg, because of complications due to vaginal mesh surgery (exposure or pain).
Exclusion criteria
Patients with mesh compliations that haven't been operated because of this complication.
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 | NL51746.018.14 |