Subjective and objective outcome after laparoscopic sacrocolpopexy

Prolapse is common medical condition for women over 40 years of age, more than
40% of these women has a prolapse [Slieker 2009]. The majority has no symptoms
of this condition; however some have severe complaints. In Dutch literature the
lifetime risk for prolapse surgery varies between 11-19% [Olsen 1997]. Increase
in this lifetime risk is expected, given the increasing expected female age and
the importance of good quality of life for the elderly. The first choice of
prolapse surgery is by native tissue repair.
However, the incidence of recurrent prolapse and the need for surgical repair,
is estimated at 10-30% [Olsen 1997]. In the case of a prolapse recurrence a
laparoscopic sacrocolpopexy using Mesh is proven to be a safe and effective
choice [Maher 2011]. At short term (<24 months), mesh surgery would have better
anatomical and functional results compared to vaginal mesh therapy [Maher
2011].
At this moment, long-term safety and efficacy is still unknown. A long-term
complication of mesh surgery is the risk of exposure, which is estimated to be
4-19% in various studies [NVOG richtlijn prolapse, p98].
This retrospective cohort of 189 women who were operated in the Diakonessenhuis
between 2004 and 2014 is an unique population to answer the question whether
the laparoscopic sacrocolpopexy is a safe and effective procedure for women
with recurrent vaginal prolapse.

The objective of the study is to evaluate the subjective and objective
effectivity and safety of the laparoscopic sacrocolpopexy of 189 patients who
underwent this procedure in the period August 2004 - December 2014 in the
Diakonessenhuis Utrecht/Zeist because of their recurrent prolapse.

The study design is a retrospective cohort study. The population of interest
will be determined by identification of the operation declaration code. Several
codes are used these passed 10 years all codes and patients will be sorted out.
Eligible patients will be sent a letter in which the study purpose and protocol
is explained. An informed consent document will be added and a validated
questionnaire as proposed by the Dutch society of obstetrics and gynaecology
with a return envelope are enclosed. Participation in the study is voluntary.
No benefit is obtained for the eligible patients, unless they consider the
outpatient visit as a *check-up*. Patients are asked to fill in the
questionnaire and the informed consent form and to return these to the
investigator. If they do not wish to participate in the study, they will be
asked to return the unfilled questionnaire with a box marked that she does not
want to participate in this study.
Several weeks after sending the questionnaire, all patients will be ringed to
make an appointment for the outpatient clinic visit to perform the gynaecologic
examination. Patients who did not return the questionnaire will be ringed to
ask to participate in the study and send back the questionnaire. When informed
consent is obtained, an appointment for the outpatient clinic visit to perform
the gynaecologic examination.
At the outpatient clinic visit the questionnaire will be checked together with
the patient. Questions will be answered. At the gynaecological examination a
POP-Q examination will be performed (a standardized method to measure the
vaginal prolapse in different compartments using manual examination) and a
speculum investigation will be done to investigate the (subclinical) exposures
of mesh. This outpatient clinic visit will take approximately 15 minutes in
duration. If abnormalities are found with the gynaecologic examination,
patients will be referred to the responsible gynaecologist and their general
physician.

Patients are asked to fill in and return a validated questionnaire (10
minutes). Also, they will be asked to participate in a outpatient clinic visit
to undergo the gynaecological examination (15 minutes).