The primary objective of this study is to review the incidence of pelvic organ prolapse after laparoscopic hysterectomy compared to vaginal hysterectomy.
ID
Source
Brief title
Condition
- Uterine, pelvic and broad ligament disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
- Incidence of anatomic vault prolapse * stage II
- Incidence of symptomatic vault prolapse (* stage II + sensation of a bulge)
- Incidence of asymptomatic and treated vault prolapse (both conservative and
surgical)
Same for prolapse in anterior and posterior compartment.
Secondary outcome
Secondary study outcome
- Incidence of conservative treatment for POP: pelvic floor exercise, vaginal
pessary
- Incidence of POP surgery: pelvic floor repair (anterior repair, posterior
repair, vaginal vault lift by sacrospinous fixation or sacral colpopexy)
- POP symptoms using PFDI-20 questionnaire (Pelvic Floor Distress Inventory)
- POP-Q values
Parameters:
- Age
- Body Mass Index
- Type of hysterectomy
- Indication for hysterectomy
- Obstetric history (parity, macrosomia, age at first delivery)
Background summary
Hysterectomy in general is a proven risk factor for pelvic organ prolapse
(POP), which can seriously discomfort women at any age and often results in
surgical repair. Especially vaginal hysterectomy (VH) results in a high number
of POPs, which is probably due to the relatively large amount of POP problems
as indication for this type of surgery. Long-term studies for pelvic organ
prolapse after the recently added laparoscopic approach have not yet been
performed. Because the uterosacral ligaments have an important function for the
level one support of the pelvic floor and are not harmed during laparoscopy, we
believe that laparoscopic hysterectomy (LH) might result in less long-term POP
problems compared to VH, when performed for the same, benign indication.
Study objective
The primary objective of this study is to review the incidence of pelvic organ
prolapse after laparoscopic hysterectomy compared to vaginal hysterectomy.
Study design
A cross-sectional cohort study will be performed of patients who underwent
laparoscopic or vaginal hysterectomy in a single center in the period of 1996
to 2004. The following items will be examined: prolapse treatment (both
conservative and surgical), current pelvic floor complaints and observed POP on
POP-examination. Therefore, a questionnaire (PFDI-20) and an invitation will be
sent for the outpatient study clinic for a one-time pelvic floor exam using the
POP-Q.
Study burden and risks
Participation in the study entails a one-time questionnaire using the PFDI-20
scale and questions about other important variables (baseline characteristics,
indication for hysterectomy, history of prolapse treatment, obstetric history)
which will take approximately 15 minutes and secondly a single visit to our
outpatient study department for a gynecological exam using the POP-Q. Subjects
will not be at any risk of complications during this study. The POP-Q is a
non-invasive, safe way to objectify pelvic floor problems. Subjects can however
experience some discomfort during the exam. Though this study will not benefit
the participators directly, it will increase our knowledge of the long-term
risk of hysterectomy on the pelvic floor. It will eventually improve
risk-assessment, counseling and possibly also treatment of patients in the
future.
De Run 4600
Veldhoven 5500MB
NL
De Run 4600
Veldhoven 5500MB
NL
Listed location countries
Age
Inclusion criteria
- Women with laparoscopic or vaginal hysterectomy between 1996-2004
- Hysterectomy for benign indication
- Women who are still alive and mobile
- Women who are aged under 80 years
- Women who understand the Dutch language
Exclusion criteria
- Subtotal or abdominal hysterectomy
- Hysterectomy for malignant disease
- Women who have passed away
- Women who are aged 80 years or older
- Women who do not understand the Dutch language
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
In other registers
| Register | ID |
|---|---|
| CCMO | NL60096.015.16 |
| OMON | NL-OMON20485 |