OBJECTIVE: It has been estimated that one in nine women will undergo a hysterectomy during lifetime. Up to 10% of these women will subsequently need surgical repair for vaginal vault prolapse thereafter. Sacral colpopexy is a generally applied…
ID
Source
Brief title
Condition
- Vulvovaginal disorders (excl infections and inflammations)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
OUTCOME MEASURES: The primary outcome will be quality of life. The urogenital
distress inventory (UDI) will be the quality of life measure in this trial.
Secondary outcome
Secondary outcome will be women*s perceived improvement in the prolapse
symptoms and clinicians post-operative grading of prolapse until one year of
follow-up, costs and cost-effectiveness.
Background summary
Women with vaginal vault prolapse commonly have a variety of pelvic floor
symptoms, which are directly related to the prolapse. The symptoms include
pelvic heaviness, bulge or protrusion coming down from the vagina, dragging
sensation in the vagina or backage. Symptoms of bladder, bowel or sexual
dysfunction are frequently present(8). All these symptoms will have a severe
impact on woman*s quality of life, which requires an effective treatment.
The incidence of posthysterectomy vaginal prolapse that requires surgery has
been estimated at 36 per 10,000 person-years (1). The risk increases
cumulatively with years after hysterectomy and increases significantly in women
whose initial hysterectomy was performed for genital prolapse (1-3). In an
aging population, the number of women that will seek medical help for a vaginal
vault prolapse will increase steadily. In the coming decades this number will
increase due to a desire to live an active life and due to the ageing
population.
The wide variety of surgical treatments available for vaginal vault prolapse
indicates the lack of concensus as to the optimal treatment. The three RCT
comparing abdominal sacral colpopexy with vaginal sacrospinous fixation
indicate an advantage for the abdominal technique. The laparoscopic technique
has been described, but never compared in a RCT with an other technique. With
the advantages of laparoscopic surgery in mind (shorted hospital stay, rapid
recovery) a comparison of the abdominal sacral colpopexy and the laparoscopic
sacral colpopexy is needed.
Study objective
OBJECTIVE: It has been estimated that one in nine women will undergo a
hysterectomy during lifetime. Up to 10% of these women will subsequently need
surgical repair for vaginal vault prolapse thereafter. Sacral colpopexy is a
generally applied treatment, that can be performed both laparoscopically or by
laparotomy. After the laparoscopic abdominal sacral colpopexy had been
reported, this procedure has gained popularity. However, the literature
regarding laparoscopic sacral colpopexy is only sparse and randomised trials
are lacking. The laparoscopic route might have advantage compared to the open
abdominal technique in terms of post operative recovery, hospital stay and
quality of life.
Study design
STUDY DESIGN: Multicentre prospective randomised controlled trial
Intervention
INTERVENTIONS: Open abdominal sacral colpopexy versus laparoscopic sacral
colpopexy
Study burden and risks
TIME SCHEDULE: Duration of the study three year For inclusion of the patients
18 months is needed. The follow-up will be one year.\Patients have to fill in
de quality of life lists
de Run 4600
5500 MB, Veldhoven
NL
de Run 4600
5500 MB, Veldhoven
NL
Listed location countries
Age
Inclusion criteria
All hysterectomised patients with a vaginal vault prolapse are elegible for the study.
Exclusion criteria
Patients with a contraindication for a surgical intervention will be excluded
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 | NL12130.015.06 |