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Objective: In parallel with the increase in cesarean section (CS) rates, sirable conditions such as abnormal or postmenstrual bleed-
the incidence of isthmocele has been increasing. In this study, we ing, chronic pelvic pain, infertility, placenta accrete or previa,
aimed to evaluate the effect of four different uterine incision closure uterine rupture, cesarean scar ectopic pregnancy [4].
techniques (single-layer locked, double-layer locked, single-layer un- CS defect size is thought to play a role in the risk of uter-
locked, and double-layer unlocked) on cesarean scar healing and ine rupture in subsequent pregnancies [5]. Although the fac-
isthmocele formation by transvaginal ultrasound (TVUS) and saline tors implicated in CS defect formation remains to be eluci-
infusion sonography (SIS). Materials and methods: This prospective, dated, changes in maternal age, uterine position, labor in-
randomized study included women who underwent the first, elec-
duction, uterine incision closure have been mostly blamed
tive, and term cesarean section delivery at the Obstetrics and Gyne-
[6]. CS defect morphology can be demonstrated by transvagi-
cology clinic of a tertiary care center between November 2018 and
nal ultrasound (TVUS), saline infusion sonography (SIS) and
November 2019. A total of 60 patients were divided into four groups
hysteroscopy [7]. It is of utmost importance to identify the
including 15 patients in each. Using the TVUS and SIS, the width,
causes of this situation and to tailor strategies to prevent this,
depth and length of the CS defect and the thickness of the residual
myometrial tissue were measured. Results: There was no significant
if possible. Therefore, the number of the articles in the litera-
difference in the CS defect measurements and CS defect area among ture regarding CS defect and treatment preferences has been
the four groups (p > 0.05). The lowest rate of Grade 3 isthmocele was increasing in recent years. Uterine incision closure tech-
seen in the double-locked group (5%), while the highest rate of isth- nique is also considered an important factor in scar healing
mocele was seen in the single-unlocked group (35%) (p > 0.05). Con- and some differences between single-layer and double-layer
clusion: No trend of differences was seen in the four subgroups but locked and unlocked techniques have been described for ce-
the sample size is not big enough to draw valid conclusions. sarean scar morphology [8].
In the light of these data, we aimed to evaluate the effect of
Keywords four different uterine incision closure techniques (i.e., single-
Cesarean delivery; Isthmocele; Saline infusion sonography; Uterus closure tech- layer versus double-layer and locked versus unlocked) on ce-
nique sarean scar healing and isthmocele formation using postpar-
tum TVUS and SIS in pregnant women delivered by the first
1. Introduction elective cesarean section.
The World Health Organization (WHO) advocates that
the ideal cesarean section rate should be below 10 to 15% in
2. Materials and methods
all societies [1]. Republic of Turkey, Ministry of Health re- 2.1 Study design and study population
ported that this rate was 57% in 2019, while the primary ce- This single-center, prospective, randomized study was
sarean rate was 27% [2]. Due to the high rates of cesarean de- conducted at Department of Obstetrics and Gynecology of a
livery in recent years, long-term adverse consequences have tertiary care center between November 2018 and November
become prevalent [3]. A cesarean scar defect is the thin- 2019. The study protocol was approved by the local Ethics
ning and indentation of the myometrium caused by inade- Committee (No: 2018/26-21). Prior to study, all patients
quate healing of the myometrium at the site of the hystero- were informed about the nature of the study and a written
tomy. Although it is usually asymptomatic, it can cause unde- informed consent was obtained. The study was conducted in
accordance with the principles of the Declaration of Helsinki. 2.3 Surgical technique
Patients with their first cesarean section between the ages All operations were performed by a single surgery team
of 18 and 40 years with a term pregnancy, who agreed to at- including four obstetrics and gynecology specialists. Follow-
tend to the control visit at six weeks postpartum, and patients ing randomization, the technique to be used was explained
whose prenatal and follow-up data were complete in the pa- to the surgeon. Routine skin cleaning was performed with
tient file were included. Those under 37 weeks of gestation, povidone-iodine before the operation. Prophylactic antibio-
with labor (having active contractions with cervical patency therapy was given with cefazolin sodium 1 g. The type of
of 4 to 5 cm or more), having placenta previa, previous uter- anesthesia (general or regional) was left to the discretion of
ine surgery, a diagnosis of immune system disorder such as the anesthesia team. In all patients, the Pfannenstiel incision
insulin-dependent diabetes mellitus, or those who did not at- was used. Fascia was opened transversely by sharp dissection
tend to follow-up were excluded from the study. All patients and the peritoneum was opened bluntly. The bladder peri-
were evaluated by SIS and TVUS at six weeks in the postpar- toneum was pushed, creating a bladder flap and, then, the
tum period. uterus was opened through a Kerr incision. Following the
delivery of the fetus, four different closure techniques were
2.2 Randomization and allocation
applied for closure of the uterus according to the groups. The
A total of 67 patients were randomized using the simple fascia was closed continuously without locking. The skin was
random number generator. All patients were operated us- sutured subcutaneously.
ing the traditional Pfannenstiel-Kerr method. Totally, 60 pa-
2.4 Outcome measurements
tients who met the inclusion criteria were included in the
Data including age, weight, height, body mass index, ges-
study. The patients were divided into four groups including
tational week, repair time of the uterus, number of additional
15 in each group. The first group was applied with the single-
sutures (defined as requirement of three or more sutures af-
layer locked, the second group with the single-layer unlocked,
ter uterine incision), total operation time, operation-related
the third group with the double-layer locked, and the fourth
complications, and time to discharge were recorded.
group with the double-layer unlocked incision closure tech-
nique. The study flow chart is shown in Fig. 1.
Table 2. Cesarean operation times of patient groups. quences and complications with high morbidity and mortal-
N Mean ±SD Min Max ity rates, such as uterine rupture, preterm labor, and placental
Single-unlocked 16 25.6875 3.71876 21.00 35.00 adhesion anomalies, which have been reported particularly in
Single-locked 15 24.3571 3.24884 20.00 32.00 subsequent pregnancies due to the failure of the cesarean scar
Double-unlocked 18 24.5789 1.70996 21.00 28.00 [10, 11]. Researchers have currently investigated the ways to
Double-locked 18 24.4444 1.88562 21.00 28.00 reduce these risks and compared the uterine incision closure
techniques [12, 13]. In the present study, we compared four
different incision closure techniques. At the postoperative
Table 3. Additional sutures of patient groups.
sixth week, we observed no significant differences in the CS
N Additional suture p
defect measurements and defect areas among the groups.
Single-unlocked 16 0 ns
Single-locked 15 2 ns In a retrospective cohort study including 149 women un-
Double-unlocked 18 0 ns dergoing elective cesarean delivery, Glavind et al. [14] ex-
Double-locked 18 0 ns amined CS defect length, width, depth and residual myome-
ns, not significant (p > 0.05). trial thickness in 68 women with single-layer closure and
81 women with double-layer closure. The authors found
that the CS defect length was greater in women with single-
in 22 (33%), fetal anomaly in 12 (18%), fetal distress in layer closure than those with double-layer closure (6.8 mm
seven (10.5%), and macrosomia in seven (10.5%) macroso- vs. 5.6 mm, respectively). However, there was no signifi-
mia. There was no significant difference between the age, cant difference in the other measurements. In the current
height, weight, body mass index, obstetric history, and smok- study, we performed single-layer locked, single-layer un-
ing and alcohol use among the groups (Table 1). locked, double-layer locked, and double-layer unlocked inci-
The data regarding cesarean operations were similar sion closure techniques. We found no significant difference
among the groups. The operation times were compara- in the CS defect length among the groups. However, unlike
ble, indicating no statistically significant difference (Table 2). the study of Glavind et al. [14], our sample size is relatively
None of the groups required blood transfusion during and small.
after the operation. There was no significant difference in
In another prospective, randomized study comparing the
terms of the use of additional sutures and blood transfusion
effects of single- and double-layer suturing techniques on
among the groups (p > 0.05 for both) (Table 3).
healing of the uterine scar following cesarean delivery, Sevket
At the postoperative sixth week, 60 patients were sched- et al. [15] applied single-layer technique to 18 women and
uled for a follow-up visit for the evaluation of the CS defect double-layer technique in 18 women. At six months, resid-
depth, width and length, and residual myometrial thickness ual myometrial thickness and CS defect depth were measured
was measured. using SIS. Markers of uterine scar healing were defined as
There was no significant difference in the CS defect mea- the healing ratio and residual myometrial thickness cover-
surements and CS defect area among the four groups (p > ing the defect. Residual myometrial thickness was signifi-
0.05) (Tables 4 and 5). The lowest rate of Grade 3 isthmocele cantly higher in the double-layer technique than the single-
was seen in the double-locked group (5%), while the high- layer technique (9.95 mm vs. 7.53 mm). The healing ratio
est rate of isthmocele was seen in the single-unlocked group was also significantly higher in the double-layer technique.
(35%) (p > 0.05) (Table 4). In a prospective study of Hayakawa et al. [16], single-layer
versus double-layer interrupted sutures and a novel method
4. Discussion developed by the authors were compared. A total of 137
In recent years, the number of cesarean operations has women who underwent first cesarean delivery (between 26
been gradually increasing, leading to many adverse conse- and 41 weeks of gestation) were assessed using TVUS at one
month after surgery and appearance of lower uterine scars Furthermore, in their prospective, longitudinal study in-
were evaluated. The first group was applied single-layer in- cluding 60 pregnant women, Ceci et al. [19] compared two
terrupted myometrium suture, the second group was applied different single-layer sutures by TVUS and hysteroscopy.
double-layer interrupted myometrium suture, and the third The patients were divided into two groups. The uterine inci-
group was applied a novel method consisting of continuous sion was closed using the locked continuous single-layer su-
suture with decidual closure, followed by interrupted my- tures in the first group and using the single-layer interrupted
ometrium suture in which the endometrial layer was per- sutures in the second group. Cesarean scar defect was greater
manently unlocked and the remaining myometrial tissue was in the first group than the second group (6.2 mm2 vs. 4.6
repaired. During regular postpartum visit on 30th to 38th mm2 ). The authors concluded that locked continuous sutures
day of surgery, residual myometrial and scar defect measure- resulted in a larger defect probably due to a greater ischemic
ments were performed using the TVUS. The authors re- effect on the uterine tissue.
ported that the rate of wedge defects was significantly higher In a systematic review and meta-analysis, Di Spiezio Sardo
in the single-layer unlocked technique than the other two et al. [20] analyzed nine randomized-controlled studies in-
techniques. Multiple regression analysis showed that increas- cluding 3,969 participants. In five studies comparing single-
ing gestational week at the time of delivery, multiple preg- layer and double-layer technique, CS defect was observed
nancy, premature rupture of membranes, and preeclampsia more frequently with the double-layer technique, although
were associated with an increased risk of wedge defects. it did not reach statistical significance. In addition, in five
In a randomized-controlled study by Bamberg et al. [17], studies, residual myometrial thickness was significantly lower
435 patients who underwent cesarean delivery were exam- with the single-layer technique. The discrepancy between
ined. Of these patients, 40% were applied the single-layer the results can be attributed to the use of different tech-
locked, 32% the single-unlocked, and 43% the double-layer niques, uterine positions, and ultrasound technologies in the
technique. Using the TVUS, CS defect depth and niche area included studies. Additionally, as there is no consensus on
measurements were calculated at six weeks and at six to 24 definition of the scar healing time, different time points were
months postoperatively. In this study, the authors found no used for the postoperative evaluation. In our study, we ana-
significant difference in the cesarean scar depth and niche lyzed the CS defect at six weeks after cesarean delivery. Un-
area measurements among the three groups at both time like the findings of Di Spiezio Sardo et al. [20], we found no
points. In a review including 21 studies, Bij de Vaate et al. significant differences between the locked versus unlocked
[18] examined the link between a niche and abnormal uterine and single-layer versus double-layer incision closure tech-
bleeding. Potential risk factors in terms of isthmocele forma- niques in terms of the cesarean scar depth, width, length and
tion were found to be the use of single-layer technique, multi- residual myometrial thickness.
ple cesarean sections, and retroverted uterus. Postmenstrual In addition to the surgical technique, the surgery itself is
spotting was the most common symptom. The authors con- a risk factor. Surgery may trigger the development of isth-
cluded that there was no significant difference in the isthmo- mocele through many factors such as inflammation, tissue is-
cele formation between the closure techniques. In our study, chemia, tissue manipulation and insufficient hemostasis [21].
however, pelvic pain was the most common symptom proba-
The main limitations of the present study are the relatively
bly due to the fact that the patients were evaluated at six weeks
small sample size and short follow-up. The main strengths
postoperatively in our study.
of this study are its prospective, randomized design, homo-
geneous study population, and the use of a valid randomiza-
tion method to examine the effect of the technique on isth-