To asses the effectiveness of surgery 7 and 10 years after conventional vaginal POP surgery compared with tension free vaginal mesh.
ID
Source
Brief title
Condition
- Obstetric and gynaecological therapeutic procedures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Effectiveness of surgery 7 and 10 years after conventional surgery compared
with tension free vaginal mesh.
Success is defined as a *composite outcome*: pelvic organ prolapse POPQ ,
leading edge < hymen and no bulge symptoms and no re-operation for POP.
Secondary outcome
Long-term complications of both techniques, with special interest in pain and
(de novo)-dyspareunia and re-operation.
Background summary
Pelvic organ prolapse (POP) is highly prevalent in the female population. There
is a high recurrence rate after vaginal POP surgery with native tissue
(20-60%). Placement of vaginal mesh aims to reduce this high recurrence rate. A
randomised controlled trial was performed in 2006-2008 (Vrouw 1 trial). In this
study follow-up was 12 months and the focus of the outcome was on anatomic
results.
There are several studies suggesting a more favorable outcome of pelvic organ
prolapse surgery when vaginal mesh is used, but the follow-up of these studies
is short (12 to 36 months)( altman 2011, Nguyen 2008, menefee 2011, nieminen
2010, sivaslioglu 2008, vollebregt 2011, Withagen 2011, Halaska 2012). There is
only one single-armed cohort study with 5 year follow-up, describing 84%
success (Jacquetin 2013).
Complications of the grafts are an important issue, especially exposure,
chronic pain and dyspareunia are complications that are ascribed to mesh,
although chronic pain and dyspareunia are also seen after POP surgery without
mesh (IGZ rapport, Withagen 2011, Vollebregt 2011, Milani 2013).
In conclusion the long-term results are scarce in regard to objective
(anatomic) and subjective (patient reported outcomes) efficacy and
complications of tension free vaginal mesh repair in compare with conventional
vaginal POP repair. It is also important to know whether native tissue repairs
are associated with a higher re-operation rate at the long term, when compared
to mesh surgery.
Study objective
To asses the effectiveness of surgery 7 and 10 years after conventional vaginal
POP surgery compared with tension free vaginal mesh.
Study design
Long-term follow-up of a previous prospective, multicentre, randomized, single
blinded study (Vrouw 1 trial)
Study burden and risks
Nature and extent of the burden:
Follow-up visit 7 years. This includes gynaecological examination, including a
3D perineal ultrasound and questionnaires.
Follow-up visit 10 years. This includes gynaecological examination and
questionnaires.
"Risks": time consuming. Extra gynaecological investigation.
Benefit: Women already participated in the study and since the media attention
and health inspectorate report, there has been a lot of anxiety and disturbance
about mesh. By participating in the present study, patients will have an extra
check for complications.
Geert Groote Plein Zuid 10
Nijmegen 6525 GA
NL
Geert Groote Plein Zuid 10
Nijmegen 6525 GA
NL
Listed location countries
Age
Inclusion criteria
a. The study population is already selected and randomisation and surgery already have taken place (Withagen 2011, Vrouw 1 trial).
b. Subject is willing to return for follow-up evaluation and/or QoL questionnaires completion at 7 years and/or 10 years after surgery.
Exclusion criteria
a. Subject is unwilling or unable to complete questionnaire and/or return for evaluation
b. Presence or treatment of malignancy in the pelvis / lower abdomen
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 | NL46834.091.14 |