The primary objective is to assess the differences in mobility of pelvic organs between three commonly performed treatment options for uterine descent (vaginal hysterectomy, vaginal sacrospinous hysteropexy and laparoscopic sacrohysteropexy). The…
ID
Source
Brief title
Condition
- Uterine, pelvic and broad ligament disorders
- Obstetric and gynaecological therapeutic procedures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Primary outcome is the mobility of the pelvic organs (displacement of the
bladder, vagina, cervix or apex and rectum) between three commonly performed
treatment options for uterine descent.
Secondary outcome
Secondary outcome is the correlation between the clinical results (MRI
findings, POP-Q assessment) and symptoms of POP.
Background summary
Pelvic organ prolapse (POP) is a common health problem. Three different
surgical techniques for treatment of uterine descent are vaginal hysterectomy,
vaginal sacrospinous hysteropexy and laparoscopic sacrohysteropexy. When
looking at de novo or recurrence of prolapse after surgery for descensus uteri,
the high rate of anterior vaginal wall prolapse after sacrospinous hysteropexy
is prominent. Studying the anatomical and functional differences after surgery
is of interest, because it might give a possible explanation of the high rate
of de novo or recurrence anterior vaginal wall prolapse after vaginal
sacrospinous hysteropexy. Furthermore, the correlation between displacement of
pelvic organs (assessed by dynamic MRI), symptoms and POP-Q has not been
determined yet.
Study objective
The primary objective is to assess the differences in mobility of pelvic organs
between three commonly performed treatment options for uterine descent (vaginal
hysterectomy, vaginal sacrospinous hysteropexy and laparoscopic
sacrohysteropexy). The secondary objective is to determine the correlation
between the clinical results (MRI findings, POP-Q assessment) and symptoms of
POP.
Study design
Pilot cross-sectional study at one time point (6 months postoperatively: MRI,
gynecological examination, questionnaire)
Study burden and risks
Participating in this study is without risks for the participants. The burden
for the participants consists of the time it takes to fill in the
questionnaire, go to the hospital and undergo a MRI scan. One extra visit to
the hospital will be necessary. The use of vaginal and rectal contrast at MRI
scanning might cause discomfort for the participants. There is no direct
benefit for the participants.
Dr van Heesweg 2
Zwolle 8025 AB
NL
Dr van Heesweg 2
Zwolle 8025 AB
NL
Listed location countries
Age
Inclusion criteria
Patients who recently underwent a vaginal hysterectomy, vaginal sacrospinous hysteropexy and laparoscopic sacrohysteropexy as a primary treatment for uterine descent (without surgery for prolapse or hysterectomy in the past)
Exclusion criteria
Factors that will preclude MRI interpretation (e.g. prosthetic hip)
Contra-indications for MRI (e.g. claustrophobia, metal clips)
Not physically able to maintain Valsalva maneuvre for at least 10 seconds (e.g. pulmonary problems)
Neurological disease affecting the pelvic floor
Previous pelvic floor surgery
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 | NL49444.075.14 |