Key words
sacrospinous ligament fixation - anchoring system - total uterine prolapse
Schlüsselwörter
Fixation am Ligamentum sacrospinale - Verankerungssystem - totaler Descensus uteri
Introduction
Sacrospinous ligament fixation (SSLF) is an effective technique that fixes the vaginal
vault to the sacrospinous ligament and restores vaginal wall support [1]. Its effectiveness is not a subject of debate and it has a success rate of more
than 90% [2]. However, the indications for this approach have been expanded to include the prophylactic
prevention of vaginal vault prolapse during hysterectomy in high-risk patients. SSLF
is a safe and feasible method that can be used together with other vaginal procedures,
particularly in patients with pelvic organ prolapse (POP). The procedure requires
sufficient experience and has a learning curve [1], [3].
Articles discussing the prophylactic use of SSLF during vaginal hysterectomy procedures
in patients with surgically weak uterosacral cardinal ligaments only began to be published
10 years after publication of a surgical procedure for vaginal cuff prolapse by Richter
in 1968 [1], [4], [5].
SSLF has an effectiveness of 96 – 98%, irrespective of whether the uterus is preserved
or not [6]. As a transvaginal procedure, SSLF is associated with fewer complications, less
preoperative pain, greater cost-effectiveness, shorter hospital stays, less blood
loss, and better preservation of sexual intercourse function compared with transabdominal
approaches. Furthermore, it provides simultaneous repair of existing gynecological
pathologies such as cystocele, enterocele, and rectocele [6]. The most frequent complications of this procedure are bleeding and buttock pain.
Life-threatening bleeding after SSLF from sacral or pudendal arteries was reported
in 3 patients out of a total of 1229 (0.2%); the blood transfusion rate for this procedure
was reported to be 2% [7]. The average objective cure rate has been reported to be 75% for unilateral SSLF
(USSLF), whereas the success rate for bilateral SSLF (BSSLF) ranges between 8 and
94% [7].
Currently, sacrospinous ligament fixation (SSLF) is the most common transvaginal procedure
described in the literature. Data on morbidity and outcomes are available because
unilateral SSLF is a common procedure. A literature review provided data from more
than 1000 patients [8], [9], [10].
The classic SSLF procedure requires good visualization of the surgical site. Deschamps
suture passer is the tool most commonly used to pass a suture through the sacrospinous
ligament with the aim of fixating the vaginal apex to the sacrospinous ligament. Good
visualization of the surgical site is necessary when using this tool. One or two long
retractors with wide surfaces can be used to provide the necessary visualization.
Use of this retractor also requires experienced assistants and adequate lighting.
A number of devices have been developed to facilitate the safe placement of sutures
in deep tissues and to eliminate some of the above-mentioned problems. One approach
consists of using hook-like instruments. In our study, we carried out surgery using
a pelvic floor repair tissue-fixing anchor, the Anchorsure System® (Neomedic Ltd). This system does not require the help of a surgical assistant experienced
in retraction or good lighting and can be performed by a single surgeon.
USSLF and BSSLF procedures were performed in patients with stage 3 and 4 prolapse
using the anchoring system. We aimed to analyze the clinical and surgical findings
and any intraoperative complications which occurred with these two procedures using
this new anchoring system. Secondary outcomes (measures of morbidity) were also compared
between the two groups.
Materials and Methods
The study was conducted in the Gynecology and Obstetrics Department of the Health
Sciences University of Istanbul Gaziosmanpaşa Training and Research Hospital between
January 2013 and February 2018. Our study was planned as a prospective randomized
controlled study. Randomization was performed on the day before surgery, using patient
protocol numbers in a computer program. The study was approved by the training plans
coordination board (EPK) and the ethics board of the hospital. A letter of ethical
approval (no. 45) was obtained from the Istanbul Gaziosmanpaşa Training and Research
Ethics Committee. All patients included in the study were informed preoperatively
about potential complications and the procedural technique; their consent was obtained
and they all signed a consent form.
Ninety-three menopausal women (diagnosed as having amenorrhea with follicle-stimulating
hormone [FSH] levels > 40 pg/mL) who were sexually active (any sexual activity in
the three months prior to surgery) and had POP-Q stage 3 or 4 uterine prolapse were
included in the study. Women who had mental, psychological or neurological disease
or who had previously had a hysterectomy, and women who were unwilling to participate
in the study were excluded. Vaginal hysterectomy (VH) was carried out in all menopausal
women.
Patients in group 1 underwent VH with unilateral sacrospinous fixation. Patients in
group 2 underwent VH with bilateral sacrospinous fixation. Anterior and/or posterior
colporrhaphy was also performed when indicated. USSLF was performed in 52 patients
who were randomly selected (group 1), and BSSLF was performed in 41 patients (group
2). All sacrospinous ligament fixation procedures were performed using the anchoring
device of the Anchorsure System® ([Fig. 1]). The anchoring applicator is a thin, straight device designed for safe anchor placement
at the sacrospinous ligament. It allows the anchor to be advanced to a maximum depth
of 12 mm for maximum placement control. It is used for spinous fixation when treating
vaginal prolapse after hysterectomy [11], [12].
Fig. 1 The Anchorsure applicator system. Prolapse & Anchoring System device (Source: Desarrollo
E Investigación Médica Aragonesa SL).
Patients in group 1 and group 2 were operated on by 3 surgeons (MDs) with at least
10 yearsʼ experience in gynecological surgery. Vaginal hysterectomy was performed
as described in Te Lindeʼs Operative Gynecology [13]. VH was initiated with a circular incision around the vaginal mucosa. The uterosacral
ligaments were clamped and sutured after opening the posterior peritoneum. Uterine
vessels were clamped and cut after cutting the cardinal ligaments. The supravaginal
septum was cut and the vesicouterine cavity was entered. The utero-ovarian and round
ligaments were clamped, cut and the uterus was removed. The infundibulopelvic ligaments
were clamped and cut, and the adnexae were removed. The pararectal area was identified
within the posterior cuff where the vaginal remnant was located, and the rectum was
moved away from the surgical site using the digital rectal maneuver to prevent rectal
injury. The vaginal mucosa was dissected blindly and sharply from the rectovaginal
septal plane, and the right rectovaginal fascial layers were passed through digitally
or using the tip of the scissors at the apical level. The spinous process and the
sacrospinous ligament were palpated. The rectovaginal fascial layers were enlarged
digitally, and a retractor was placed to make room for the anchoring tool. The anchoring
device was advanced to the anchoring point under the guidance of the index finger
of the other hand. The applicator insert was advanced transvaginally until the anchor
was in direct contact with the sacrospinous ligament. Once the tissue to which the
anchor would be applied was reached, the anchor was placed in the sacrospinous ligament-coccygeus
muscle complex at about 1.5 – 2 cm medial to the spinous process using the anchoring
device. Prolene sutures at the tip of the anchor were then used to fixate the vaginal
vault to the sacrospinous ligament. A suture was passed medially through the vaginal
cuff in both groups. The procedure was repeated on the other side for patients who
underwent bilateral fixation.
Data including patient age, parity, medical problems, menopausal status, and previous
surgeries were obtained from the patientsʼ history at the time of the procedure. Patients
were categorized during physical examination using the POP-Q classification of prolapse.
Operations performed in addition to the SSLF procedure, duration of surgery, duration
of hospital stay, and early complications including bleeding requiring transfusion,
nerve injury, gastrointestinal injury and abscess in the urinary system or ischiorectal
abscess or hematoma were recorded. Surgical failure and recurrence rates were evaluated
6 months postoperatively. Febrile morbidity (persisting fever of 38 degrees or more
lasting for more than 24 hours and requiring the use of antibiotics) was diagnosed.
Patientsʼ re-presentations to hospital in the first week after the procedure were
monitored for surgical complications.
Anatomical outcome
A simplified POP-Q system, a valid and reliable staging method to determine the extent
of pelvic organ prolapse in individuals and the period of prolapse, was used to evaluate
patients [14]. After patients had evacuated their bladders and were placed in the lithotomy position,
they were asked to strain or cough vigorously. Measurements were taken based on 4
criteria points which included the cervix, posterior fornix, and anterior and posterior
vaginal walls with the hymen level as the reference point. The level of prolapse was
rated for each point as follows: stage 1, the most distal part of the prolapse is
more than 1 cm over the hymen; stage 2, the most distal part of the prolapse is located
between 1 cm over and 1 cm below the hymen; stage 3, the most distal part of the prolapse
is more than 1 cm below the hymen; and stage 4, full eversion of the lower genital
tract [14]. POP-Q staging was performed preoperatively in patients and again 6 months postoperatively
in both groups. The results were recorded.
Statistical analysis
When evaluating the study data, in addition to descriptive statistical methods such
as mean values and standard deviation, Studentʼs t-test was used to compare normally
distributed parameters and evaluate quantitative data, and Mann-Whitney U-test was
used to evaluate parameters which were not normally distributed. The level of significance
was accepted as p < 0.05.
Results
Demography
Between 2013 and 2018, VH and SSLF was performed in 93 patients with uterine prolapse
in our clinic. USSLF was performed in 52 patients (group 1) and BSSLF was performed
in 41 patients. The mean age in group 1 and group 2 was 62.76 ± 6.6 years and 61.25 ± 8.7
years, respectively. Mean parity of group 1 and group 2 was 3.88 ± 1.2 and 4.06 ± 1.04,
respectively. All patients were post-menopausal. All ninety-three patients had systemic
diseases that did not constitute contra-indications for surgical procedures (mostly
obstructive pulmonary diseases, diabetes mellitus, and hypertension). No statistical
differences were found between the two groups with respect to age, body mass index
(BMI), duration of menopause, topical or systemic estrogen use, chronic obstructive
pulmonary disease, diabetes mellitus, hypertension, smoking, previous surgical history,
parity, and POP-Q stage. The groups were similar in terms of their demographic characteristics
and findings on physical examination ([Table 1]).
Table 1 Characteristics of the groups.
|
Parameters
|
Group 1
Unilateral sacrospinous (n = 52)
|
Group 2
Bilateral sacrospinous (n = 41)
|
p value
|
|
DM: diabetes mellitus, COPD: chronic obstructive pulmonary disease
|
|
Age (years)
|
62.76 ± 6,6
|
61,25 ± 8,7
|
0.3437
|
|
BMI (kg/m2)
|
27.84 ± 4.61
|
29.1 ± 3.01
|
0.1337
|
|
Parity
|
3.88 ± 1.2
|
4.06 ± 1.04
|
0.4486
|
|
History of surgery
|
|
|
|
|
|
8 (15.3)
|
7 (17.07)
|
0.8185
|
|
|
11 (21.1)
|
8 (19.5)
|
0.85
|
|
|
8
|
5
|
0.6595
|
|
|
6
|
4
|
0.7843
|
|
|
26
|
24
|
0.416
|
|
|
1
|
–
|
0.3750
|
|
Topical or systemic estrogen use
|
8 (15.3)
|
6 (14.6)
|
0.92
|
|
Smoking status
|
4 (7.69)
|
3 (7.31)
|
0.94
|
|
DM
|
5 (9.61)
|
4 (9.75)
|
0.9988
|
|
Hypertension
|
10 (19.2)
|
8 (19.51)
|
0.974
|
|
Duration of menopause (years)
|
14.02 ± 3.03
|
15.09 ± 2.87
|
0.0870
|
|
COPD
|
5 (9.6)
|
3 (7.31)
|
0.6972
|
|
Preoperative POP-Q stage (range)
|
3.4 ± 0.4
|
3.5 ± 0.3
|
0.1862
|
Additional procedures performed simultaneously with the SSLF procedure are shown in
[Table 2] for both groups. VH was performed in all patients in both groups. Procedures that
most commonly accompanied the VH + SSLF procedure included anterior colporrhaphy,
posterior colporrhaphy, enterocele repairs, and transvaginal tape-obturator (TOT)
procedures. No significant differences were found between the two groups with respect
to the frequency of additional procedures.
Table 2 Additional procedures performed concurrently with vaginal hysterectomy and sacrospinous
ligament fixation.
|
Procedure
|
Group 1
Unilateral sacrospinous ligament fixation (n = 52)
|
Group 2
Bilateral sacrospinous ligament fixation (n = 41)
|
p value
|
|
|
n (%)
|
n (%)
|
|
|
TOT: transvaginal tape-obturator
|
|
Anterior colporrhaphy
|
42 (80.7)
|
35 (85.3)
|
0.5622
|
|
Posterior colporrhaphy
|
30 (57.6)
|
28 (68.2)
|
0.2977
|
|
Enterocele repair
|
7 (13.4)
|
6 (14.6)
|
0.865
|
|
TOT
|
11 (21.1)
|
10 (24.3)
|
0.7152
|
Adverse events
Mean hospital stay of patients from the USSLF group and the BSSLF group was 2.3 ± 0.9
days and 2.4 ± 0.8 days, respectively. The mean time used to fixate the sacrospinous
ligament to the vaginal cuff was 76.6 ± 10.7 minutes for group 1 and 80.5 ± 11.8 minutes
for group 2. No statistically significant differences were noted between the two groups
with respect to mean duration of surgery, mean hospital stay, or mean blood loss.
No bladder, rectal or nerve injury or serious bleeding requiring blood transfusion
occurred intraoperatively. No patient developed any early complications such as ischiorectal
abscess, hematoma or febrile morbidity. Stage 1 cystocele developed in 3 patients
in the BSSLF group; there was no recurrence of rectoceles or enteroceles. In the USSLF
group, a stage 2 cystocele was found in 1 patient. There were no statistically significant
differences between the two groups with respect to cystocele occurrence. Based on
the results of anatomical healing in patients, neither procedure was superior to the
other. POP-Q staging was performed 6 months postoperatively, and no statistically
significant differences were found between the two groups. The success rate for the
group that underwent USSLF procedures using the anchoring system was 96.1% (50/52
women). The success rate for the BSSLF group, however, was 100% (41/41 women). No
statistically significant difference was found between the two groups. Recurrence
(vaginal cuff prolapse) was found in 2 patients in the USSLF group at follow-up 6
months postoperatively. There was no recurrence in the BSSLF group. The two cases
with recurrence presented with stage 2 and stage 3 vaginal cuff prolapse, respectively.
Laparoscopic sacrocolpopexy was performed in these patients ([Table 3]).
Table 3 Comparison of variables and intraoperative, immediately postoperative, and late complications
between the two groups.
|
Clinical outcomes and complications
|
Group 1
Unilateral sacrospinous ligament fixation with vaginal hysterectomy
n: 52
|
Group 2
Bilateral sacrospinous ligament fixation with vaginal hysterectomy
n: 41
|
p value
|
|
ns: not significant
|
|
Operating time (min)
|
76.6 ± 10.7
|
80.5 ± 11.8
|
0.098
|
|
Hospital stay (days)
|
2.3 ± 0.9
|
2.4 ± 0.8
|
0.0604
|
|
Estimated blood loss (ml)
|
133 ± 40.9
|
140.4 ± 50.8
|
0.43
|
|
Complications
|
|
|
|
|
Bladder injury, n (%)
|
0
|
0
|
ns
|
|
Rectal injury, n (%)
|
0
|
0
|
ns
|
|
Febrile morbidity
|
0
|
0
|
ns
|
|
Ischiorectal abscess
|
0
|
0
|
ns
|
|
Required blood transfusion
|
0
|
0
|
ns
|
|
Nerve injury
|
0
|
0
|
ns
|
|
Hematoma
|
0
|
0
|
ns
|
|
Significant recurrence
|
2 (3.84)
|
0
|
ns
|
|
Pop-Q stage postoperatively
|
0.7 ± 0.4
|
0.6 ± 0.3
|
0.1862
|
|
Cystocele recurrence
|
1 (1.9)
|
3 (7.3)
|
0.2056
|
Discussion
In our prospective randomized study, we investigated whether unilateral sacrospinous
ligament fixation using the Anchorsure system or bilateral sacrospinous fixation procedures
were superior. The system we used is based on placement of an anchor [15] and solves the problem of catching the suture without retraction. We used this device
in all 93 patients.
We carried out a MEDLINE search and reviewed 22 articles on sacrospinous ligament
fixation. SSLF was carried out in 1229 patients, and data for 1062 of these patients
was obtained. The objective cure rate in these studies ranged between 8 and 94%. Recurrent
pelvic relaxation developed in 109 patients out of 1062 (18%). Of these patients,
7 out of 81 with cystocele, 20 out of 32 with vaginal vault eversion, and 4 patients
out of 24 with rectocele required re-operation. Based on the data obtained, it was
concluded that SSLF is effective for the treatment of vaginal vault prolapse [7]. Lantzsch et al. reported on 123 patients who underwent SSLF; after a mean follow-up
of 4.8 years, the rate of recurrent vault prolapse was 3.25%, and the cystocele rate
was 8% [16]. Based on a retrospective analysis of 486 patients who had undergone pelvic reconstructive
surgery, Porges and Smilen found that adding SSLF to VH in patients with stage 3 prolapse
reduced the risk of recurrence from 15.8 to 6.7% [17]. In the series by Cruikshank and Cox consisting of 135 patients who underwent VH,
SSLF was added to the procedure in 48 patients (35%). Vault prolapse was found in
only one patient at the end of a mean follow-up period of 2 years [18].
Some studies do not recommend carrying out SSLF during VH. Colombo et al. [19] performed a retrospective case control study comparing 62 patients who underwent
SSLF concurrently with VH and a control group of 62 patients who underwent culdoplasty;
prolapse was found to have recurred in 17 (27%) patients in any vaginal area after
follow-up periods ranging between 4 and 9 years, while recurrence in the control group
was 9 in the same period (15%) (p = 0.14). Recurrence of vault prolapse was found
in 5 patients (8%) and 3 patients (5%) in the SSLF and control groups, respectively
(p = 0.72). The investigators concluded that prophylactic SSLF should not be recommended
to patients with uterovaginal prolapse. In our study, recurrence (vaginal cuff prolapse)
was found in only 2 patients who underwent prophylactic unilateral SSLF in addition
to hysterectomy. The success rate in the USSLF group using the anchoring system was
96.1% (50 women out of 52). Two patients in the USSLF group required re-operation.
In the bilateral SSLF group, however, the success rate was 100% (41 women out of 41);
no vaginal vault prolapse was found in any patient.
It appears that cystocele development is one of the leading long-term complications
of sacrospinous ligament fixation. The reason for this is that the vaginal axis is
shifted to a posterior and more horizontal position, resulting in greater exposure
of the anterior vaginal wall to increased intraabdominal pressure. Figures ranging
between 0 and 92% have been reported for cystocele development after SSLF [20]. In a study of 36 patients who underwent SSLF with a mean follow-up of 42 months,
Holley et al. [21] reported that cystocele developed in 33 patients (92%), rectocele developed in 6
(17%), and enterocele was found in 2 patients (6%), while recurring vault prolapse
was seen in 3 patients (8%). In contrast, in a retrospective case control study of
patients who had SSLF with or without anterior colporrhaphy, Smilen et al. [20] suggested that SSLF did not result in increased development of cystocele when performed
alone; however, adding anterior colporrhaphy to SSLF increased the risk. In the study
by Szess and Karram, the postoperative anterior vaginal wall relaxation rate was reported
to be 7.6% (81 out of 1062). In another study, the same authors reported a similar
recurrence rate of 7% after anterior colporrhaphy [7], [22]. Sacrospinous ligament fixation can also be used for cystocele correction, as shown
in the study by Fünfgeld et al. [23].
In our study, 3 (7.3%) patients developed stage 1 cystocele, and there was no recurrence
of rectocele or enterocele. In the USSLF group, however, stage 2 cystocele was seen
in 1 patient (1.9%). There were no significant differences between the two groups
with respect to the recurrence of cystocele.
The recurrence of prolapse after SSLF can be due to several factors, including inherent
tissue weakness in the patient, neuropathy related to wide vaginal dissection, or
anatomical distortion caused by the surgical procedure. The reason for the lower rate
of recurrent prolapse in our study may be due to the fact that the anchoring system
we used required less vaginal dissection compared with SSLF carried out using the
classic open technique.
Although rare, SSLF can have serious intraoperative and postoperative complications.
The most frequent complication is hemorrhage related to pudendal vascular injuries.
Other complications include pudendal and sciatic nerve injuries, bladder injuries,
gluteal pain, and suture abscess [7], [24], [25]. Pohl and Frattarelli found that bilateral SSLF resulted in increased blood loss
of 25 – 50 mL and that the operative time was 20 – 30 minutes longer compared with
unilateral SSLF [26]. No serious intraoperative complications developed in our study.
We found only one article in the literature that directly compared unilateral and
bilateral SSLF [25]. Jones et al. performed BSSLF in 62 patients and USSLF in 41 patients. Anatomical
cure rates for both procedures were similar, irrespective of SSLF type (37/41 women
[90.2%], unilateral SSLF, compared with 53/62 [85.5%], bilateral SSLF; p = 0.56).
Women in the unilateral SSLF group had more blood loss and longer operative times
than those in the bilateral SSLF group (p = 0.02). No statistically significant differences
were found between the two groups in terms of intraoperative complications, transfusion
rates, urinary retention, febrile morbidity, re-admissions to hospital, cystitis,
postoperative incontinence, and hospital stay [27]. In our study, vaginal vault prolapse recurrence was found in 2 patients in the
USSLF group. No recurrence of vaginal vault prolapse was seen in the BSSLF group.
There were no significant differences between the two groups. In contrast to Jonesʼ
study, in our study there were no statistically significant differences between the
two groups with regard to blood loss or duration of surgery. We attribute this to
the anchoring system requiring less dissection and consequently reducing the amount
of bleeding [27]. In the literature, sacrospinous fixation with Anchorsure under local anesthesia
has also been described in older patients and patients with anesthesia risks [28].
Conclusions
Our study is limited by the relatively small number of patients and short follow-up
period. But our study is noteworthy as it is only the second article in the literature
that directly compares unilateral and bilateral SSLF procedures. Morbidity rates for
bilateral SSLF performed using a new suturing device with an anchor appear to be no
different from those seen with unilateral SSLF.
Compliance with Ethical Standards and Ethics Approval
Compliance with Ethical Standards and Ethics Approval
The study was approved by the Ethics Committee of Gazi Osman Paşa Taksim Research
and Education Hospital. Informed consent was obtained from all recruited subjects.
