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PROGRAMSTUDI S1 KEPERAWATAN
SEKOLAH TINGGI ILMU KESEHATAN YAHYABIMA
TAHUN 2020
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Obstetrics and Gynecology International
Volume 2020, Article ID 7367403, 6 pages
https://doi.org/10.1155/2020/7367403

Research Article
Comparative Retrospective Study of Tension-Free Vaginal
Mesh Surgery, Native Tissue Repair, and Laparoscopic
Sacrocolpopexy for Pelvic Organ Prolapse Repair

Haruhiko Kanasaki , Aki Oride , Tomomi Hara, and Satoru Kyo

Department of Obstetrics and Gynecology, Faculty of Medicine, Shimane University, Izumo, Japan

Correspondence should be addressed to Haruhiko Kanasaki; kanasaki@med.shimane-u.ac.jp

Received 17 June 2019; Accepted 24 March 2020; Published 10 April 2020

Academic Editor: W. T. Creasman

Copyright © 2020 Haruhiko Kanasaki et al. is an open access article distributed under the Creative Commons
Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the
original work is properly cited.
Introduction and Hypothesis. Many would argue that sacrocolpopexy is the standard surgical procedure for pelvic organ prolapse
(POP), but other surgical techniques were proposed and practically applying to the patients with POP. In this study, we compared
postoperative outcomes of three surgical methods for POP repair. Methods. We identified that 308 women who had undergone
surgical repair of POP were followed up for at least 6 months. Recurrence rates of POP after tension-free vaginal mesh (TVM)
surgery (n � 243), native tissue repair (NTR) (vaginal hysterectomy with colpopexy, anterior and posterior colpoplasty, or
circumferential suturing of the levator ani muscles and apical repair by transvaginal sacrospinous ligament fixation (SSLF)) (NTR;
n � 31), and laparoscopic sacrocolpopexy after subtotal hysterectomy (LSC; n � 34) were compared. Presence of mesh erosion
was also recorded. Results. Patients who underwent LSC were significantly younger (65.32 ±3.23 years) than those who
underwent TVM surgery (69.61 ±8.31 years). After TVM surgery, the rate of recurrence (over POP-Q stage II) was 6.17% (15/243)
and was highest in patients with advanced POP. recurrence rate in patients who underwent NTR procedure was 3.23% (1/34) and
that in patients who underwent LSC was 11.76% (4/11). was no statistically significant difference in the recurrence rate between
the three types of surgery. were 13 cases (5.35%) of mesh erosion after TVM surgery and none after LSC surgery. risk of
mesh erosion was correlated with having had total TVM surgery but not with patient age or POP stage. Repeat procedures were
performed in 5 women (2.14%) who underwent TVM surgery and 1 (2.94%) who underwent LSC. No patient underwent repeat
surgery after NTR. was no statistically significant difference in the reoperation rate between the three types of surgery.
Conclusion. Our study suggested that TVM surgery, NTR, and LSC have comparable outcomes as for the postoperative recurrence rate
and mesh erosion. However, the outcomes of each technique need to be carefully evaluated over a long period of time.

1. Introduction for POP. However, the pelvic floor structures become

progressively weaker postoperatively in older women,
Pelvic organ prolapse (POP) is a distressing health problem contributing to a high rate of recurrence, especially in the
affecting about 15%–30% of women over 50 years of age [1]. anterior compartment [4]. Tension-free vaginal mesh
reported lifetime risk of surgery for POP ranges from 6% (TVM) surgery for POP was first reported by French gy-
to 19% [2, 3]. Although a large number of surgical repair necologists in 2004 [5]. there was a rapid increase
techniques for POP have been described, treatment of this in transvaginal placement of synthetic mesh implants for POP
condition continues to be a clinical challenge for urogy- in the belief that it was simpler to perform, less invasive,
necological surgeons. Japanese gynecologists have tradi- potentially able to preserve the uterus, and more effective than
tionally performed vaginal hysterectomy (VH), anterior and the traditional NTR [6]. Use of synthetic mesh in-creased by up
posterior colpoplasty, or circumferential suturing of the to 40% in the USA [7]. However, in 2008 and again in 2011, the
levator ani muscles as a native tissue repair (NTR) procedure US Food and Drug Administration (FDA)
2 Obstetrics and Gynecology International

expressed concern about the use of mesh for POP repair used as described elsewhere [13]. However, because of the
because of postoperative complications, including mesh lack of availability of mesh kits for TVM surgery in Japan,
exposure, mesh retraction, pain, and dyspareunia [8]. we used monofilament polypropylene mesh (Polyform,
FDA reports caused much controversy and raised ongoing Boston Scientific) cut into a shape similar to that used
questions about whether or not TVM surgery was appro- previously in the Prolift system (Ethicon, Somerville, NJ).
priate for POP. Despite the number of randomized con- TVM surgery included anterior TVM, posterior TVM, anterior
trolled trials that have investigated the use of mesh in and posterior TVM (TVM-AP), and total TVM (performed in
female prolapse surgery, use of TVM remains controversial. patients with vaginal stump prolapse following hysterec-
Abdominal sacrocolpopexy is widely used to repair tomy). TVM with a modified shape of mesh with four arms
apical vaginal prolapse but is not a popular method in was applied to the patients with a rectocele after hysterec-
Japan. However, with advances in laparoscopic surgery, tomy (Enterocele-TVM; E-TVM). LSC was performed in the
it is now possible to perform laparoscopic conventional manner [11] after subtotal hysterectomy.
sacrocolpopexy (LSC). efficacy and safety of LSC for Polypropylene mesh (Polyform) which was manually cut into
apical vaginal prolapse is now considered equivalent to an appropriate shape was positioned in the anterior
that of ASC [9]. Furthermore, LSC is a uterus-sparing vesicovaginal space and secured to the anterior vaginal wall
surgery, so it is becoming an increasingly common by absorbable #2-0 PolysorbTM (Covidien Japan, Tokyo,
procedure [10] and has been reported to have a higher Japan) and uterine cervix by unabsorbable #0 Ti-CronTM
success rate and lower reoperation rate than TVM [11]. (Covidien Japan, Tokyo, Japan). mesh was then tightly
first-line surgical procedure for POP is still not fixed to the anterior longitudinal ligament at the sacral
established because each of these three procedures has promontory by #0 Ti-CronTM. mesh was not placed
both advantages and disadvantages. In 2010, we started to posteriorly in any of the patients who underwent LSC to
per-form TVM surgery in patients with POP rather than con- avoid unexpected complications. Instead, posterior colpo-
ventional NTR (VH, colpoplasty, or circumferential suturing plasty was applied if necessary.
of the levator ani muscles). However, after an FDA warning All procedures were chosen and performed by either of
about transvaginal mesh in 2011 [12], we reverted to two surgeons after examining the leading edge of the pelvic
performing conventional NTR with addition of apical repair floor. patients were discharged 3 days after surgery and
by transvaginal sacrospinous ligament fixation (SSLF). monitored for complications in the outpatient clinic at 1, 3, 6,
Furthermore, at the end of 2015, we started using LSC for
and 12 months postoperatively. Postoperative recurrence of
POP repair, especially in relatively younger women. In this
POP was defined as POP-Q stage II or higher after the
study, we retrospectively reviewed the outcomes, i.e., re-
currence and mesh erosion, of these three types of POP initial operation. One-way analysis of variance or the chi-
surgery. complications of TVM surgery were also evaluated, squared test was used to test for statistically significant
given that this was the most common procedure performed. between-group differences in postoperative outcomes. A P
value <0.05 was considered statistically significant.
3. Results
2. Materials and Methods
We performed 308 POP repairs between January 2010 and
Data were collected retrospectively from medical records of May 2018. Table 1 shows the details and outcomes of the
patients who underwent POP surgery between January operations performed. During the study period, 243 patients
2010 and May 2018 in the Department of Obstetrics and (approximately 79%) underwent TVM surgery, 31 (10.1%)
Gyne-cology at Shimane University Hospital after underwent NTR, and 34 (11.0%) underwent LSC. was
institutional review board approval and patient consent were a statistically significant difference in mean age between the
obtained (20170224-1). In total, 308 women with TVM group (69.61 ±8.31 years) and the LSC group (65.32
preoperative POP quantification (POP-Q) over stage II were ±3.23 years) (P <0.01). TVM surgery and LSC were mainly
identified to have undergone prolapse repair (stage II; 68, performed in women with POP-Q stage III and NTR in
stage III; 203, stage IV; 37). All patients were evaluated by women with POP-Q stage II. During a minimum of 6 months
physical examination with vaginal speculum in the decubitus of follow-up after the initial surgery, recurrence of POP,
position at rest and during a Valsalva maneuver, and then, defined as POP-Q stage II or higher, occurred in 15 patients
TVM surgery, NTR (VH with anterior or posterior (6.17%) after TVM surgery, in 1 patients (3.23%) after NTR,
colpoplasty, circumferential suturing of the levator ani and in 4 case (11.76%) after LSC surgeries. Mesh exposure
muscles, and SSLF as apical re-pair), or LSC was chosen was found in 13 (5.35%) of the 243 patients who underwent
according to patient age and background, POP-Q stage, TVM surgery but not in any of the 34 patients who
and predominant descending part. underwent LSC. was no statistically significant difference in
Conventional NTR and TVM surgery were performed under the recurrence rate or mesh exposure rate between the
lumbar spinal anesthesia in the lithotomy position. VH,
colpoplasty, and circumferential suturing of the levator ani three types of surgery. A second operation was performed
muscles were performed in the usual fashion. SSLF was in 5 (2.14%) of the 243 women in the TVM surgery group
because of postoperative complications. Al-though most of
performed using a Capio ™ SLIM device (Boston Scientific, these complications were asymptomatic, 3 of the 5
Natick, MA) in all cases. A conventional TVM technique was
women required a second operation due to continuous
Obstetrics and Gynecology International 3

TABLE 1: Surgical procedures and postoperative outcomes.

Surgery TVM surgery NTR LSC P
N 243 31 34
a
Age (years) 69.61 8.31 (46–88) 65.68 11.34 (35–85) 65.32 3.23 (44–70) P 0.01
II 45 (18.5%) 14 (45.2%) 9 (24.5%) <
± ± ± P b
POP-Q stage III 168 (69.1%) 11 (35.5%) 24 (70.6%) 0.01
30 (12.3%) 6 (19.4%) 1 (0.03%) <
Recurrence (%) IV 15 (6.17％) 1 (3.23) 4 (11.76％) NS
Mesh erosion (%) 13 (5.35％) N/A 0 NS
Reoperation (%) 5 (2.14％) 0 (0％) 1 (2.94％) NS
(Erosion, n � 3. Recurrence, n � 2) (Recurrence)
a
ANOVA. bChi-squared test. NS: not statistically significant; TVM: tension-free vaginal mesh; NTR: native tissue repair; LSC: laparoscopic sacrocolpopexy.

vaginal bleeding caused by mesh erosion and the remaining difference in the postoperative mesh exposure rate
2 underwent repeat TVM surgery because of subjective according to the POP-Q stage (Table 3(b)). However,
symptoms such as a sensation of dragging or difficulty when the mesh erosion rate was classified according to
voiding. A second operation (anterior and posterior TVM) the type of TVM surgery, it was significantly higher in the
was performed to treat POP recurrence in 1 of the 34 pa- women who un-derwent total TVM surgery (Table 3(c)).
tients who underwent LSC. Only 1 of the 31 women who Mesh erosion took at least 6 M to become apparent in
underwent NTR had postoperative POP recurrence, which patients who underwent TVM surgery (Table 3(d)).
is not presently serious, and she remains under follow-up. POP recurrence rate after NTR and LSC procedures
data for the 243 women who underwent TVM surgery was also reviewed, even though these procedures were
were then reviewed in more detail. Table 2 sum-marizes the performed less often than TVM surgery. Only 1 of the 31
data for patient age, POP-Q stage, and type of TVM surgery patients in the NTR group had recurrence. patient was
performed according to whether or not there was a recurrence 75 years old and had a stage II uterine prolapse. A POP-Q
during follow-up. Although the age range of these patients was stage II cystocele was noticed in this patient at a routine
wide, most were aged between 60 and 80 years. Recurrence of visit 6 months after the initial NTR. She did not undergo a
POP was observed in 9 (9.78%) of 92 women in their 60s, 1 second operation and continues to be followed up without
(3.13%) of 32 in their 50s, and 5 (5.0%) of 100 in their 70s. any medical intervention. Four women had recurrence after
highest recurrence rate after TVM surgery was in the women in LSC; 1 of these women had POP-Q stage II before surgery
their 60s; however, there were no significant age-related and 3 had stage III (Table 4). was no statistically significant
differences in the recurrence rate (Table 2(a)). POP did not association between POP-Q stage and recurrence rate after
recur in any patient with POP-Q stage II, whereas recurrences LSC (Table 4(a)). recurrence was noticed 6 months
were noted in 8 (4.77%) of 168 patients with stage POP-Q postoperatively in 2 cases, at 3 months in 1 case, and at 1
stage III and 7 (23.33%) of 30 patients with stage IV (Table year in the remaining case (Table 4(b)). Only 1 of these 4
2(b)); the between-group differences were statistically women underwent anterior and posterior TVM surgery
significant (between POP-Q stage II and IV and between POP- because of an intolerable dragging sensation.
Q stage III and IV). POP recurrence was observed in all types
of TVM surgery per-formed and was particularly common in
patients with POP-Q stage IV (Table 2(b)). Anterior and
4. Discussion
posterior TVM surgery was the most commonly performed TVM In this retrospective study, we characterized surgical practice
procedure and had a recurrence rate of 6.9% (10/145), which for POP in terms of recurrence rate and mesh erosion. Like
was similar to the overall recurrence rate for TVM surgery. was most gynecologists in Japan, we have traditionally per-
no significant difference in the recurrence rate according to the formed NTR without apical suspension (VH, anterior and
type of TVM surgery performed (Table 2(c)) or in time since posterior colpoplasty, or circumferential suturing of the
surgery (Table 2(d)). Recurrence was noticed as early as 3 levator ani muscles) but started performing TVM surgery in
months in some cases and as late as 3 years in others. 2009 because of its reportedly favorable cure rate and low
complication rate [14]. During this time, we have also
We then reviewed the patients in whom erosion of the performed NTR with SSLF in selected cases because we
mesh occurred after TVM surgery (Table 3). mesh erosion rate found that vaginal vault prolapse was common in patients
was 50% (1/2) in women in their 40s, 12.5% (4/32) in those in who underwent NTR without apical suspension at our in-
their 50s, 1.1% (1/92) in those in their 60s, and 7.0% (7/100) in stitution. We started performing LSC after the FDA warning
those in their 70s. Younger women tended to have a higher rate about the use of TVM in 2011 [12]. Patients were selected for
of mesh erosion, but there were no significant between-group LSC on the basis of age and whether or not they were
age-related differences (Table 3(a)). mesh erosion rate was sexually active. of the 308 patients who were
6.67% (3/45) in patients with POP-Q stage II and 4.17% (7/168) treated surgically for POP during the study period, the
and 10.0% (3/30), respectively, in those with POP-Q stage III majority underwent TVM surgery, which was our first-line
and IV. was no statistically significant treatment during the study period, and the remaining
4 Obstetrics and Gynecology International

TABLE 2: Cases of recurrence after TVM surgery. TABLE 3: Cases of mesh erosion after TVM surgery.
(a) Age ∗
Age ∗ (a) Age Mesh
(years) Recurrence, n Total, n Recurrence, (%) Age (years) erosion Total % of erosion
41–50 0 2 0 41–50 1 2 50
51–60 1 32 1.13 51–60 4 32 12.5
61–70 9 92 9.78 61–70 1 92 1.1
71–80 5 100 5 71–80 7 100 7
81–90 0 17 0 81–90 0 17 0
15 243 (b) Stage#
(b) POP stage# Stage Mesh Total % of erosion
Stage Recurrence, n Total, n Recurrence, (%) II 3 45 6.67
II 0 45 0 III 7 168 4.17
III 8 168 4.77 IV 3 30 10
IV 7 30 23.33 13 243
15 243 (c) Types of surgery
∗∗
(c) Type of surgery Surgical type ∗∗ Mesh
Surgical Total % of erosion
erosion erosion
Recurrence, n Total, n Recurrence, % TVM-A 2 49 4.08
type
TVM-A 2 49 4.08 TVM-AP 5 149 3.45
TVM- TVM-P 0 1 0
10 145 6.9 T-TVM 6 42 14.29
AP E-TVM 0 6 0
TVM-P 1 1 100 13 243
T-TVM 1 42 2.38
(d) Mesh erosion after initial surgery
E-TVM 1 6 16.67
Months Cases % of total cases
15 243
3M 0 0
(d) Recurrence after initial surgery
6M 3 20.00
Proportion of all 12 M 4 26.67
Month Cases
cases (%) 24 M 5 33.33
3 3 20 36 M 1 6.67
6 2 13.33 FIG 13 100.00
12 5 33.33
#
24 3 20.00 ∗
No statistically significant differences were found between each age group. No
36 2 13.33 ∗∗
statistically significant differences were found. P <0.01, the chi-squared test.
15 100.00
∗
No statistically significant differences were found between each age group. In a study reported by Achtari et al. in 2005, patient age
# ∗∗ was identified as a risk factor for mesh erosion [17], and
P <0.01, the chi-squared test. No statistically significant
Deffieux et al. subsequently reported that age over 70 years
differences were found. was an independent predictor [18]. Furthermore, Kaufman
reported that age and sexual activity were risk factors for
women underwent NTR or LSC; younger women mesh erosion [19]. reports indicated that the risk of mesh
were more likely to undergo LSC. erosion may be highest at the extremes of life. However, in
Although stage II POP was relatively common in our our study, there was no age-related pattern to the likelihood
NTR group, there was no relationship between the type of of mesh erosion. finding is consistent with that in a recent
surgery performed and the preoperative severity of POP or report by Niu et al. [20], where no significant difference in
the recurrence rate during our study period. Furthermore, age was found between their groups with and without mesh
although there were no cases of mesh erosion after LSC, exposure. Furthermore, our expe-rience was that mesh
statistical evaluation showed that the rate of mesh erosion erosion was significantly more likely to occur after total TVM
was not different between the TVM surgery group and the surgery. finding suggests that previous hysterectomy could
LSC group (both of which involve use of mesh). In addition, be one of the risk factors for postoperative mesh erosion
the reoperation rates for mesh erosion and/or recurrence of after TVM surgery. In this connection, a previous report
POP were not significantly different between the TVM showed that vaginal sling procedures for urinary
surgery, NTR, and LSC groups, suggesting that these three incontinence and concomitant hysterectomy were predictors
procedures have comparable surgical outcomes. of mesh erosion [21]. Ciga-rette smoking, operative
Regarding outcomes of TVM surgery, POP recurrence rate technique, the type of mesh used, and presence of diabetes
was 6.17% at our institution over an 8-year period and is similar have also been reported to be predictors of mesh erosion
to that reported by Caquant et al. (6.9% during 6–18 months of [12, 22].
follow-up) [14] and Sho et al. (7.0% during a median follow-up
Although most of our POP r epairs in the past 9 years
of 35.9 months) [15]. Moreover, as previously re-ported [16], we
were performed using TVM, the number of TVM proce-
found that only severe prolapse before surgery was associated
with anatomic failure postoperatively.
dures performed at our institution has steadily decreased
Obstetrics and Gynecology International 5

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