Discussion
We report an analysis of data collected from routine care to compare the
medium-term efficacy and safety of the 3 most common surgical procedures
for pelvic organ prolapse repair in a population of 2309 women. The
events were uncommon: the rate of serious complications ranged from
1.4% after native tissue vaginal repair to 3.8% after transvaginal
mesh placement, and the rate of reoperations for recurrence from 2.8%
after vaginal repair to 0.9% after transvaginal mesh. The women in the
vaginal repair group were exposed to the lowest risk of serious
complications and the highest risk of reoperation for recurrence, the
women in the transvaginal mesh group to the highest risk of serious
complications and the lowest risk of reoperation for recurrence, and the
women in the laparoscopic sacropexy group to an intermediate risk of
serious complications and a low risk of reoperation for recurrence, like
in the transvaginal mesh group.
The strengths of our study are its large prospective registry including
19 centres and numerous surgeons; these features enable the detection of
rare events. The analysis covers
operations performed in real-life situations: complex clinical
situations were not excluded. Indeed, a high proportion of our
population would not have been included in a randomized trial, because
they were too old, because of prolapse recurrence after previous
surgery, or various comorbidities. The regular and routine verification
of the information from the hospitals databases and from a sample of the
participants is evidence of validity.
Our primary outcome was based on a robust criterion, as the modified
Clavien–Dindo classification has been found to be a valid and
reproducible classification of complications in various surgical
domains.11,12 It
is easy to verify serious complications and reoperations by consulting
the hospital’s data department and the women who had surgery.
Our results must be interpreted
considering the absence of
randomization. The surgical groups had different characteristics.
However, we took the women’s preoperative characteristics into account
with the propensity score to emulate a comparative
trial.14 The data about the construction of the
propensity score appear reassuring regarding potential unmeasured
confounders that may bias our results. In addition, within each surgical
group, there were multiple and different surgical procedures. These
limitations are the price of a ”real world” study design, which can
introduce variance and limit statistical power.
Another limitation is the medium-term follow-up averaging 16 months.
However, a Finnish cohort found that most complications of POP surgery
occurred within the two first postoperative months.11Wihersaari
O, Karjalainen P, Tolppanen A-M, Mattsson N, Jalkanen J, Nieminen K.
Complications of Pelvic Organ Prolapse Surgery in the 2015 Finnish
Pelvic Organ Prolapse Surgery Survey Study. Obstet Gynecol
2020;136:1135-44. Five year after transvaginal mesh placement,
another study found that 79% of the mesh exposures occurred during the
first postoperative year.22Jacquetin B, Hinoul P, Gauld J,
Fatton B, Rosenthal C, Clavé H, Garbin O, Berrocal J, Villet R,
Salet-Lizée D, Debodinance P, Cosson M. Total transvaginal mesh (TVM)
technique for treatment of pelvic organ prolapse: a 5-year prospective
follow-up study. Int Urogynecol J 2013;24:1679–86.
Our results about the relative risk of serious complications are similar
to earlier comparative studies, reporting fewer complications with
vaginal surgery without mesh.33Siddiqui NY, Cara L. Grimes CL,
Casiano ER, Abed HT, Jeppson PC, Olivera CK, Sanses TV, Steinberg AC,
South MM, Balk EM, Sung VW. Mesh Sacrocolpopexy Compared With Native
Tissue Vaginal Repair, A Systematic Review and Meta-analysis. Obstet
Gynecol 2015;125:44–55.,44Maher C, Feiner
B, Baessler K, Christmann-Schmid C, Haya N, Brown J. Surgery for women
with anterior compartment prolapse. Cochrane Database of Systematic
Reviews 2016, Issue 11. Art. No.: CD004014. The incidence of
complications in our registry was lower than that reported in several
trials. This difference may be explained by the definition used for
complications, which considered only serious Clavien-Dindo
complications. The risk of reporting failure seems marginal, as we
systematically and regularly verified the information with the
hospitals’ data departments and with the women. Most participating
hospitals are teaching hospital centres specialized in management of
recurrent prolapse. This point may explain the low complication rate.
Verification of this hypothesis might also mean that transvaginal mesh
use by experienced centres might be at low risk of complications.
Today as concerns about mesh safety abound, our results offer real-world
information for women that can enable them to participate in the choice
of technique most appropriate for them. It suggests that in the medium
term, laparoscopic sacropexy may have the best risk profile. Vaginal
repair has a minimal risk of serious complications, but a higher risk of
reoperation for recurrence.
Because reporting the specific functional results of prolapse surgery
for each type of surgical procedure appears useful, we have planned a
questionnaire to send to all the women in our registry. Identifying the
technical surgical details that are at greater risk of complications
than others (such as the type of mesh or the sutures used) should help
improve surgical procedures. Assessing the effect of the experience of
both surgeons and centres could be useful for determining if some
procedures should be reserved to expert centres.