Results
Between February 2017 and November 2019, 2309 women underwent a surgical
repair for pelvic organ prolapse by 110 surgeons in 19 centres, agreed
to participate in the registry and were included in the analysis.
We estimate that the surgical
procedures included in the analysis represent about 76.6% of eligible
procedures for POP repair performed during the study period in the 19
centres (Table S1).
The vaginal repair group included 504 women, the transvaginal mesh group
692, and the laparoscopic sacropexy group 1113 (including 128 with
robotic assistance; Table S2). Eight women in the laparoscopic sacropexy
group needed a conversion (0.7%): three times to a laparotomic
sacropexy, twice to laparoscopic lateral attachment, twice to
transvaginal mesh, and once to vaginal repair. One or more other
surgical procedures were associated with prolapse surgery, including
midurethral sling placement or hysterectomy (Table S2).
The surgical groups differed in terms of age, body mass index, diabetes,
menopausal status, smoking, previous hysterectomy, previous surgery for
stress urinary incontinence or for pelvic organ prolapse, and anatomical
defect (Table S3). Seven of the 12 covariates in the planned propensity
score had weighted maximum standardized differences below 10%, while 5
(age, menopausal status, history of POP surgery, history of
hysterectomy, and anatomical anterior defect) exceeded the threshold by
a maximum of 4% (Figure S1).
Mean follow-up was 16.6 months (0.4 to 33.8). During this period, 52
women had Clavien-Dindo grade III or higher complications (Table S4).
During surgery or in the first 48 hours after: 7 women had an
intraoperative injury, 4 a postoperative haemorrhage or hematoma, and 1
a cardiac infarct. From 2 days to 2 months 18 women required a surgical
treatment of complications (some women with more than one type of
complication): 1 had a peritonitis related to ileal injury, 1 an
appendicitis, 1 an incisional eventration with intestinal inclusion
after laparoscopy, 1 a bladder retention related to transvaginal mesh, 7
a haemorrhage or hematoma, 4 an ureteral obstruction, 4 a pelvic
abscess, 1 a severe postoperative pain after sacrospinofixation, and 2 a
vaginal mesh exposure. Between 2 and 12 postoperative months, 20 women
required surgical treatment for a complication (5 women had 2
complications each): 11 had a vaginal mesh exposure, 1 a bladder mesh
exposure after sacropexy, 3 a severe chronic pain, 2 a ureteral
obstruction after transvaginal mesh, 2 an incisional hernia after
laparoscopy, and 3 a vaginal granuloma. Two women returned to the
operating room more than a year after the prolapse surgery: 1 for an
incisional hernia after laparoscopy, and 1 for toxin injection for de
novo overactive bladder. Complications necessitated 16 interventions to
remove the mesh totally or partially (0.9%).
The cumulative weighted incidence of serious complications (Figure 1,
Table 1) showed a difference between the groups in favour of vaginal
repair: 1.8% for vaginal repair (95% CI 0-3.9), 3.9% for transvaginal
mesh (2.0-5.9), and 2.2% for sacropexy (1.1-2.6) at 12 months. Compared
with the sacropexy group, the risk of serious complications was higher
among women in the transvaginal mesh group (weighted-adjusted HR 1.55,
1.03 to 2.34). A concomitant total hysterectomy was associated with a
higher risk of complications (Table 1).
Due to a recurrence of the prolapse, a second intervention was required
for 32 women (1.4%): 14 after vaginal repair (2.8%), 6 after
transvaginal mesh (0.9%), and 12 after sacropexy (1.1%). The
cumulative weighted incidence of reoperation for prolapse recurrence at
12 months was 1.5% for vaginal repair (95%CI 0.4-2.5), 0.7% for
transvaginal mesh (0-1.4), and 1.1% for sacropexy (0.3-1.9). Compared
with the vaginal repair group, the risk of reoperation for prolapse
recurrence was reduced in the transvaginal mesh and sacropexy groups
(Figure 2; Table 2), with no significant differences between the latter
two groups.
Postoperative stress incontinence resulted in reoperation for 61 women
(2.6%): 6 after vaginal repair (1.2%), 28 after transvaginal mesh
(4.0%), and 27 after sacropexy (2.4%).
In accordance with the design of the registry, we audited a sample of
women included in 2017 and 2018 (61% of 1,575 women responded). The
responses showed that 96.3% of the serious complications were already
listed in the registry as were 94.1% of the reoperations for prolapse
recurrence.