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doi:10.1111/jog.12593

J. Obstet. Gynaecol. Res. Vol. 41, No. 4: 565–574, April 2015

Purse-string double-layer closure: A novel technique for repairing the uterine incision during cesarean section Cem Turan, Esra Esim Büyükbayrak, Aylin Onan Yilmaz, Yasemin Karageyim Karsidag and Meltem Pirimoglu Department of Obstetrics and Gynecology, Dr Lutfi Kirdar Kartal Education and Research Hospital, Istanbul, Turkey

Abstract Aim: To compare the classical double-layer uterine closure to a double-layer purse-string uterine closure (Turan technique) in cesarean section regarding short- and long-term results. Methods: Patients were randomized into either the double-layer purse-string uterine closure arm (study group, 84 patients) or the classical double-layer uterine closure arm (control group, 84 patients). For short-term comparison, a detailed transvaginal ultrasound examination was planned in all patients 6 weeks after the operation and a wedge-shaped defect in the uterine incision scar was accepted as uterine scar defect and recorded. For the long-term comparison, subsequent pregnancies of these patients were followed up for any complication. Results: The number of patients with ultrasonographically visible uterine scar defect was 12 (23.5% of all scar defects) in the study group whereas it was 39 (76.5% of all scar defects) in the control group (P < 0.001, χ2 = 15.42). Demographic data, operation time, hospitalization time, preoperative and postoperative hemoglobin values were not significantly different between the groups. During the 2-year of the follow-up period, five patients in the study group and six patients in the control group became pregnant again. No complication during their pregnancies and second cesarean operation were encountered. Conclusion: With the Turan technique, the uterine incision length becomes shorter, and the frequency of uterine scar defect is lower regarding short-term results. More data is needed for long-term results. ClinicalTrials.gov NCT01287611 Key words: cesarean section, purse-string closure, scar defect, surgical technique.

Introduction Cesarean section is one of the most common abdominal operations throughout the world.1,2 While cesarean section is a common procedure performed on women worldwide, there is little information available to inform decisions regarding the most appropriate surgical technique to adopt.2 Many variations in cesarean section technique have been studied. For example, single-layer uterine closure has been compared to double-layer uterine closure3–5 and closure with

different suturing materials6,7 and different incisions8–10 has also been studied. The existence and the characteristics of a wedgeshaped defect in the uterine incision scar were demonstrated by radiologic, ultrasonographic, endoscopic and histologic methods by various authors.11–18 Cesarean scar defect is a deficient uterine scar or scar dehiscence following a cesarean section involving myometrial discontinuity at the site of a previous cesarean section scar.17 Cesarean scar defects may be associated with many clinical problems such as ectopic

Received: March 25 2014. Accepted: August 13 2014. Reprint request to: Professor Cem Turan, Department of Obstetrics and Gynecology, Dr Lutfi Kirdar Kartal Education and Research Hospital, Department of Obstetrics and Gynecology, Semsi Denizer street No: 1 34890 Cevizli, Kartal, Istanbul, Turkey. Email: [email protected]

© 2014 The Authors Journal of Obstetrics and Gynaecology Research © 2014 Japan Society of Obstetrics and Gynecology

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pregnancy at the cesarean section scar, rupture of the uterus during a subsequent pregnancy, dysmenorrhea and abnormal uterine bleeding during the nonpregnant state.1 These complications are likely to be associated with poor uterine scar healing following cesarean sections.17 Methods concerning closure of the uterine incision need to be considered with regards to benefit and potential harm in order to offer the best available surgical care to women undergoing cesarean section. Surgical suturing technique and mechanical tension affecting the surgical wound are the most important factors related to the incisional integrity. For this reason, we designed this prospective randomized clinical study to analyze the effects of two different uterine suturing techniques. Our aim was to compare the double-layer purse-string closure of the uterine incision (Turan technique) to classical double-layer closure regarding incidence of postoperative defective healing of the uterine incision as short-term result and to compare complications (e.g. incisional ectopic pregnancy, placental invasion problems, complete or incomplete uterine rupture, intra-abdominal adhesions) during subsequent pregnancy of these patients as long-term results.

Methods This prospective, randomized clinical study was conducted at the Dr Lutfi Kirdar Kartal Education and Research Hospital Obstetric Clinic between February 2011 and February 2014. The study was approved by the local ethics committee (Istanbul University, Istanbul Medical School, Clinical Research Ethics Committee, 02.10.2011, 312), and written informed consent was obtained in all cases. All of the pregnant women with cesarean section indication applying to the delivery room within the study period (1 year) were recruited prospectively into the study. Exclusion criteria were: pregnant women who declined to participate; women under 18 years of age; preterm pregnancies (4 cm dilatation); emergency situations (fetal distress, cord prolapse, severe pre-eclampsia, eclampsia, placental abruption, placenta previa, vasa previa); a history of uterine surgery (e.g. hysterotomy, myomectomy, perforation); presence of maternal disease (diabetes mellitus, connective tissue disorders, uterine malformations); presence of chorioamnionitis; and presence of uterine incision other than Kerr incision (transverse

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lower segment uterine incision), expanded Kerr incision during operation or presence of myoma on the Kerr incision site. One author evaluated all of the obstetric patients who applied to the delivery room within the study period and selected eligible cases. After excluding patients who did not meet inclusion criteria and patients who declined to participate, all remaining patients were randomized into either the double-layer purse-string uterine closure arm (study group) or the traditional double-layer uterine closure arm (control group) using sealed, consecutively numbered envelopes containing computer-generated numbers (Randomization Generator Version 1.0), which were opened when the women were recruited. The allocation ratio was 1:1. The patients were blinded to the groups, and two authors performed the operations randomly. Another author who was blinded to the suturing technique performed all of the ultrasonographic examinations at the 6-week follow-up visit. All cesarean sections were performed using the Pfannenstiel and Kerr techniques for abdominal and uterine incisions, respectively. In the control group, one separate holding suture at each corner was applied then the uterine incision was closed including decidual layer with a double-layer continuous locking suture using no. 1 polyglactin 910 string (Fig. 1). The Turan technique used in the study group may be summarized as follows: beginning in one corner, the incision is closed using no. 1 polyglactin 910 suture. The first layer is transversely passed through the inner myometrium–decidua line, and the second layer is transversely passed through the outer myometrium–visceral peritoneum line continuously in the form of a purse-string closure. With this

Figure 1 Intraoperative picture of traditional suturing (arrows show edges of the uterine incision).

© 2014 The Authors Journal of Obstetrics and Gynaecology Research © 2014 Japan Society of Obstetrics and Gynecology

Closure of uterus during cesarean section

method, the original string is returned to the starting point and tied with a knot. Following the doublelayered purse-string closure, the aperture left in the middle of the uterine incision is closed with one separate figure of eight suture (Fig. 2, Video 1). On rare occasions, additional single sutures for hemostasis were added when deemed necessary in both arms of the study. Exteriorization of the uterus and parietal peritonization and apposition of the rectus musculature and the subdermal space were performed in both arms. During the operations, one author recorded the type of uterine closure technique used, operation time (min), Kerr incision length (cm) before and after suturing and whether additional sutures for hemostasis were needed. Every patient received a prophylactic dose of antibiotics (cefazolin sodium vial. 1 g, i.v.). All patients were discharged within 3 days of the operation and a detailed transvaginal ultrasound examination was planned for all patients 6 weeks after the cesarean section. Ultrasonographic examination was carried out transvaginally with the woman in the lithotomy position and with an empty bladder using high-frequency transducers of 5–6 MHz (Siemens Acuson Antares, 10032747, serial no. 113207). Uterine dimensions as well as the presence of intracavitary, parametrial and subvesical hematoma formation were recorded. The length of the incision was measured in transverse axis and recorded. The integrity of the incision was checked in transverse and longitudinal sections. A wedge-shaped distortion in the integrity of the uterine incision scar was accepted as uterine scar defect and recorded as primary outcome measure of the short-term results of the study (Fig. 3). The height of the defect was recorded also.

Figure 2 Intraoperative picture of the Turan technique and drawing of the Turan technique (arrows show edges of the uterine incision).

Complete blood count results for all patients were recorded before and after the operation and at the 6-week ultrasonographic check up. All of the patients were asked to inform the authors of a subsequent pregnancy. The subsequent pregnancies and cesarean sections were followed up by the same authors for any kind of complications like incisional ectopic pregnancy, placental invasion problems, complete or incomplete uterine rupture, intra-abdominal adhesions. Data were analyzed using SPSS version 16.0. Continuous variables with normal distribution were compared by independent Student’s t-test; otherwise, the Mann–Whitney U-test was used to compare two independent groups. All categorical variables were compared by the χ2-test, Fisher’s exact test and two-sided Z-test accordingly. The results were evaluated within 95% confidence interval, and P-values less than 0.05 were accepted as statistically significant.

Results The patient flow diagram is shown in Figure 4. In total, 168 patients were eligible for our study; 84 patients were allocated to the study group and 84 patients were allocated to the control group. Due to expanded Kerr incisions, four patients in the study group and three

Figure 3 Ultrasonographic view of uterine incisional defect (arrow shows the uterine defect).

© 2014 The Authors Journal of Obstetrics and Gynaecology Research © 2014 Japan Society of Obstetrics and Gynecology

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CONSORT 2010 Flow Diagram Enrollment

Assessed for eligibility (n=720)

Excluded (n=559) ♦ Not meeting inclusion criteria (n=512) ♦ Declined to participate (n=47) ♦ Other reasons (n=0)

Randomized (n=168)

Allocation Allocated to intervention (n=84) ♦ Received allocated intervention (n=80)

Allocated to intervention (n=84) ♦ Received allocated intervention (n=81)





Did not receive allocated intervention (due to expanded Kerr incision) (n= 4)

Did not receive allocated intervention (due to expanded Kerr incision) (n= 3)

Follow-Up Lost to follow-up (give reasons) (n=29)

Lost to follow-up (give reasons) (n=16)

Discontinued intervention (give reasons) (n=0)

Discontinued intervention (give reasons) (n=0)

Analysis Analysed (n=51) ♦ Excluded from analysis (give reasons) (n=0)

Analysed (n=65) ♦ Excluded from analysis (give reasons) (n=0)

Figure 4 CONSORT flow diagram.

patients in the control group did not receive their allocated intervention. In addition, 29 patients in the study group and 16 patients in the control group were lost to follow-up and did not come to the 6-week check up. Statistical analysis is based on data from the remaining 51 study group and 65 control group patients. However, for intention to treat analysis, demographic data, cesarean section indications and operation details were also calculated for all allocated patients and are given in Tables 1–3. Demographic data including age, parity, body mass index and gestational age were not significantly differ-

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ent between the groups (Table 4). Distribution of indications according to the groups was not significantly different between the two groups (Table 5). The secondary outcome measures of the study were: operation time; uterine incision length after suturing; hospitalization time; and preoperative and postoperative hemoglobin values. Operation time, hospitalization time, and preoperative and postoperative hemoglobin values were not significantly different between the groups (Table 6). Mean uterine incision lengths before suturing were 12.0 ± 1.9 cm in the study group and 12.3 ± 2.3 cm in the control group (P = 0.36,

© 2014 The Authors Journal of Obstetrics and Gynaecology Research © 2014 Japan Society of Obstetrics and Gynecology

Closure of uterus during cesarean section

Table 1 Demographic data of the groups

Age (years) Gravidity (median) Parity (median) BMI Gestational age (weeks)

All allocated patients in the study group (n = 84)

All allocated patients in the control group (n = 84)

P

29.2 ± 5.0 2 (1–7) 1 (0–4) 29.0 ± 4.1 38.4 ± 1.0

28.3 ± 5.2 2 (1–9) 1 (0–6) 29.2 ± 4.1 38.5 ± 1.2

0.272† 0.072‡ 0.140‡ 0.763† 0.582†

†Independent samples Student’s t-test, ‡Mann–Whitney U-test. BMI, body mass index.

Table 2 Distribution of cesarean section indications according to the groups

Elective CS One previous CS Two previous CS Cephalopelvic disproportion Presentation anomaly Macrosomic fetus

All allocated patients in the study group (n = 84)

All allocated patients in the control group (n = 84)

P*

2 (2.4%) 40 (47.6%) 6 (7.1%) 23 (27.4%) 6 (7.1%) 7 (8.3%)

3 (3.6%) 40 (47.6%) 5 (6.0%) 23 (27.4%) 5 (6.0%) 8 (9.5%)

1.000 1.000 0.755 1.000 0.755 0.787

*χ2-Test or Fisher’s exact test. CS, cesarean section.

Table 3 Comparison of two techniques

Operation time (min) Length of uterine incision before suturing (cm) Length of uterine incision after suturing (cm) No. of patients who needed additional sutures Duration of hospital stay (days) Preoperative hemoglobin value (g/dL) Postoperative 1st day hemoglobin value (g/dL)

All allocated patients in the study group (n = 84)

All allocated patients in the control group (n = 84)

P

28.5 ± 9.0 12.1 ± 1.8 4.3 ± 1.9 25 (29.8%) 2.5 ± 0.6 11.4 ± 1.3 11.1 ± 1.4

27.3 ± 4.8 12.4 ± 2.3 8.5 ± 1.8 39 (46.4%) 2.5 ± 0.5 11.5 ± 1.4 11.3 ± 1.5

0.975§ 0.343‡

Purse-string double-layer closure: a novel technique for repairing the uterine incision during cesarean section.

To compare the classical double-layer uterine closure to a double-layer purse-string uterine closure (Turan technique) in cesarean section regarding s...
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