To investigate the hypothesis that women with uterine prolapse stage 2 or more treated by laparoscopic sacrohysteropexy will have equal or lower recurrence rate of prolapse compared to women treated by vaginal sacrospinous hysteropexy.
ID
Source
Brief title
Condition
- Uterine, pelvic and broad ligament disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Anatomical outcome and recurrence rate assessed by the POP-Q test at 1 and 5
years follow-up. Recurrence rate is defined as uterine prolapse >= 2 with
symptoms.
Secondary outcome
Subjective improvement on urogenital symptoms and quality of life (assessed by
disease-specific and quality of life questionnaires), complications following
surgery, hospital stay, post-operative recovery and sexual functioning,
costs-effectiveness.
Background summary
Uterovaginal prolapse is a common health problem affecting up to 40% of parous
women over 50 years old. The lifetime risk of surgery for pelvic organ prolapse
by the age of 85 years is 19%. Pelvic organ prolapse has significant negative
effects on a woman*s quality of life. In the Netherlands, vaginal hysterectomy
is the leading treatment method for patients with symptomatic uterovaginal
prolapse. Several studies have shown that vaginal sacrospinous hysteropexy and
laparoscopic sacrohysteropexy are safe and effective alternatives in treating
uterine descent. It is unclear to date which of these techniques leads to the
best operative result and the highest patient satisfaction.
Study objective
To investigate the hypothesis that women with uterine prolapse stage 2 or more
treated by laparoscopic sacrohysteropexy will have equal or lower recurrence
rate of prolapse compared to women treated by vaginal sacrospinous
hysteropexy.
Study design
A multi-center, prospective, randomised, non-blinded clinical trial. Evaluation
will take place in every center pre-operatively, and 6 weeks, 6 months, 12
months and annually thereafter till 60 months after surgery.
Intervention
Random allocation to vaginal sacrospinous hysteropexy or laparoscopic
sacrohysteropexy.
Study burden and risks
As we compare two strategies that are already applied in current practice, no
additional risks from both procedures are expected. Buttock pain occurs in
10-15% of patients after vaginal sacrospinous fixation, but resolves
spontaneously. In laparoscopic sacrohysteropexy, there is a risk of
mesh-erosion.
Extra visits to the hospital for follow-up and data obtaining will be necessary
for both groups.
Dr van Heesweg 2
Zwolle 8025 AB
NL
Dr van Heesweg 2
Zwolle 8025 AB
NL
Listed location countries
Age
Inclusion criteria
Uterine descent POP-Q stage >= 2 requiring surgery. Patients with co-existing anterior/posterior defects or concomitant incontinence surgery (TVT-O) can be included.
Exclusion criteria
Previous pelvic floor or prolapse surgery
Wish to preserve fertility
Known malignancy or abnormal cervical smears
Unwilling to return for follow-up or language barriers
Presence of immunological/haematological disorders interfering with recovery after surgery
Contraindications for laparoscopic surgery (ileus, risk of severe adhesions)
Abnormal ultrasound findings of uterus or ovaries, or abnormal uterine bleeding
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 | NL43801.075.13 |