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Barbed Versus Conventional Suture for Uterine Repair During Caesarean Section: A Randomized Controlled Study
OBSTETRICS
Barbed Versus Conventional Suture for Uterine Repair During Caesarean Section: A Randomized Controlled Study Leonti Grin, MD; Ahmet Namazov, MD; Ale Ivshin, MD; Mark Rabinovich, MD; Victoria Shochat, MD; Simon Shenhav, MD; Ofer Gemer, MD; Efraim Zohav, MD; Eyal Y. Anteby, MD Department of Obstetrics and Gynecology, Barzilai University Medical Center, Faculty of Health Sciences, Ben-Gurion University of Negev, Ashkelon, Israel
Résumé L. Grin
Abstract Objective: This study sought to compare the short-term outcome of uterine incision repair during a Caesarean section (CS) using a bidirectional knotless barbed suture versus polyglactin suture. Methods: A randomized controlled trial was conducted at a university hospital. Participants undergoing a CS were randomized for uterine incision closure by bidirectional knotless barbed suture (group A) or polyglactin (group B). The primary outcome was the time needed to repair the uterine incision. The analysis was by intent to treat. A sample size of 35 per group (n = 70) was planned to detect a 30% reduction in uterine repair time (Canadian Task Force Classification I). Results: From July 2016 through October 2017, 150 women were screened, and 70 were statistically analyzed: group A (n = 35) and group B (n = 35). Time to complete uterine incision repair was 308 § 57 seconds for group A and 411 § 74 seconds for group B (P < 0.001). Total surgery time (33.4 § 8.8 minutes vs. 33.2 § 7.5 minutes; P = 0.64) was not significantly different between groups A and B, respectively. Conclusion: Repair of the CS uterine incision with barbed suture compared with polyglactin suture reduces suturing time.
Key Words: Caesarean section, uterine repair, barbed suture, postpartum hematoma, Caesarean section blood loss, C-section Corresponding author: Dr. Ahmet Namazov, Department of Obstetrics and Gynecology, Barzilai University Medical Center, Faculty of Health Sciences, Ben-Gurion University of Negev, Ashkelon, Israel. [email protected] This study is registered on ClinicalTrials.gov (Closing Uterine Incision During C-section Using Barbed Suture [Stratafix] or Vicryl Suture [NCT03159871]). Competing interests: The authors declare that they have no competing interests. Received on December 3, 2018 Accepted on January 7, 2019
tude cherchait a comparer les issues a court terme de Objectif : Cette e barbillons bidirectionnels sans nœud et de la suture de la suture a polyglactine pour la fermeture d’une incision chirurgicale durant une sarienne ce ae te mene dans un Méthodologie : Un essai clinique randomise ^pital universitaire. Les participantes qui subissaient une ho sarienne ont e te re parties ale atoirement en deux groupes pour la ce rine : suture a barbillons bidirectionnels fermeture de l’incision ute sans nœud (groupe A) ou suture de polyglactine (groupe B). L’issue tait le temps ne cessaire pour refermer l’incision ute rine. primaire e te effectue e. Un Une analyse selon l’intention de traiter a e chantillon de 35 patientes par groupe (n = 70) e tait pre vu pour e tecter une re duction de 30 % du temps de re paration de l’ute rus de tude canadien). (classification I du Groupe d’e Résultats : Entre juillet 2016 et octobre 2017, 150 femmes ont participe lection, et 70 ont fait l’objet d’une analyse au processus de se statistique dans les groupes A (n = 35) et B (n = 35). Le temps cessaire a la fermeture de l’incision ute rine e tait de 308 § 57 ne secondes pour le groupe A et de 411 § 74 secondes pour le groupe B rence significative dans la dure e totale de la (P < 0,001). Aucune diffe te observe e entre les groupes A et B, (33,4 § 8,8 chirurgie n’a e minutes contre 33,2 § 7,5 minutes, respectivement; P = 0,64). rine d’une ce sarienne est plus Conclusion : La fermeture de l’incision ute barbillons qu’avec une suture de polyglactine. rapide avec une suture a © 2019 The Society of Obstetricians and Gynaecologists of Canada/La Société des obstétriciens et gynécologues du Canada. Published by Elsevier Inc. All rights reserved.
J Obstet Gynaecol Can 2019;000(000):1−8 https://doi.org/10.1016/j.jogc.2019.01.011
INTRODUCTION
aesarean section (CS) is the most common abdominal surgical procedure performed in women worldwide.1,2 Nevertheless, there are numerous variations in the technical aspects of the operation.
C
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Uterine incision repair during a CS can be accomplished using a synthetic or catgut suture, with either single- or double-layer closure technique. There is currently a lack of evidence to recommend a particular technique or suturing material regarding short-term or long-term outcome.3−8 Surgeons most often choose the technique and suture on the basis of their personal experience and preference. With technological advances and given the increasing rates of CSs,2 exploration of novel techniques can lead to improvements in patient care. The bidirectional knotless barbed suture (BKBS) is a relatively new class of suture in obstetric surgery. It was introduced with the aim to reduce operative time and blood loss, and several studies in gynaecology showed a significant benefit with its use.9−13 The present study aimed to evaluate the role of BKBS for uterine incision repair during CS. In a prospective randomized trial, we compared two different suture materials used for a double-layer closure of the uterine incision with regard to the time needed to complete uterine repair and other short-term parameters. MATERIAL AND METHODS Study Design
This trial was conducted as a single university hospital, randomized controlled trial in accordance with the Consolidated Standards of Reporting Trials guidelines (Closing Uterine Incision During C-section Using Barbed Suture [Stratafix] or Vicryl Suture [NCT03159871]). We enrolled patients planned for delivery by a CS at our labour and delivery unit. Only patients planned for delivery by CS were approached for study participation. We included women who had no more than two previous deliveries by CS. All participants gave written informed consent before inclusion in the study. This study was approved by the Ethics Committee of our university hospital (BRZ 0018-16 CTIL; June 1, 2016). Sample Size
The sample size was calculated on the basis of the primary outcome measure, which was time needed to complete uterine incision repair. The average time for uterine closure in our department was calculated in patients who underwent elective CS (7 § 2.8 minutes); the sample size was calculated for a 30% reduction in time needed for uterine repair, with an alpha of 0.05 and a power of 80%. Given this calculation, the minimum sample size was 32 cases in each group (1:1 ratio of exposed to unexposed); a 10% rate of loss to follow-up was considered, yielding a total of 70 participants.
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Study Process
Study enrolment occurred between July 2016 and October 2017, and participants were followed up through November 2017. The data analysts, postpartum staff, and participants remained blinded to treatment allocation throughout the duration of the study. Surgeons were unmasked to randomization only after scrubbing for the surgery. Although the surgeons could not be blinded to the type of suture because of different appearances of these materials, neither the participants nor the experimenters who assessed the study results knew who received a particular suture. Of the 150 women undergoing a CS from July 2016 to October 2017 who were approached, 73 consented to participate and were randomly allocated to either group A or group B (Figure). Reasons for exclusion were lack of consent or an urgent CS not allowing time to elicit an informed consent, suspected placenta accreta, and a known blood clotting disorder. In group A, the uterine incision was repaired using a BKBS in a continuous two-layer technique. In group B, the uterine incision was repaired with polyglactin in a continuous two-layer technique. Three patients from group A were excluded because of unavailability of the intervention at the time of surgery. The randomization sequence was computer generated, and the principal investigator and co-investigators were responsible for enrolling participants and assigning participants to interventions. The surgical nurse was instructed to prepare either a tensile-strength size 1-0 absorbable BKBS (Stratafix Spiral PDO, Ethicon, Somerville, NJ) or polyglactin absorbable suture (Vicryl, Ethicon). The surgeon became aware of the type of suture only after the operation had begun, thus potentially eliminating patient selection bias. A total of three attending surgeons participated in the study. A standard technique was performed in all operations. The type of anaesthesia was chosen by the anaesthesiologist without reference to the treatment group. Surgical procedures were performed by an attending physician with a resident, who was aware of the nature of the study. All participants received chlorhexidine skin preparation unless there was a documented allergy, in which case povidone-iodine was used. Standard sterile draping of participants was performed. The abdomen was opened by a Pfannenstiel incision. After the transverse uterine incision in the lower uterine segment with the scalpel, the uterine incision was bluntly expanded. A
Barbed Versus Conventional Suture for Uterine Repair During Caesarean Section
Figure. Flow of participants in a trial of barbed versus polyglactin for uterine repair during a Caesarean section.
Enrollment
Assessed for eligibility (n = 150)
Excluded (n = 80) Not meeting inclusion criteria (n = 10) Refused to participate (n = 67)
Analysis
Follow up
Allocation
Randomized (n = 73)
Allocated to uterine repair with barbed suture, Group A (n=38) Did not receive allocated intervention (Due to intervention unavailability) (n=3 )
Allocated to uterine repair with a standard suture, Group B (n = 35) Did not receive allocated intervention (n=0)
Lost to follow up (n = 0)
Lost to follow up (n = 0)
Discontinued intervention (n = 0)
Discontinued intervention (n = 0)
Analyzed (n = 35)
Analyzed (n = 35)
transverse lower segment uterine incision was repaired with two layers of a continuous suture, and additional single figure-eight polyglactin sutures were applied to ensure hemostasis if required. In group A, BKBS was used in a two-layered, continuous, non-locking technique (according to the manufacturer’s instructions). In group B, polyglactin was used with a twolayered suture, the first layer a continuous locking and the second layer a continuous non-locking technique. Endometrium was included in the suture in both study and control groups. The visceral and parietal peritoneum was not re-approximated.8,14,15 The rectus fascia was closed with a
continuous non-locking technique. Rectus muscles were not closed. Subcutaneous tissue was sutured with interrupted absorbable sutures (polyglactin 2-0). The skin was approximated using staples. All patients received intraoperative prophylactic intravenous cefazolin (2 g). The patients were followed up during their hospital stay and until 30 days after the operation. A telephone questionnaire was used to assess the presence or absence of complications during convalescence. The two study arms were compared with regard to the primary outcome, which was the time required for uterine incision repair. We included both closure of the incision
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and additional sutures if performed. Additional sutures were noted when one or more extra sutures were applied in addition to the two-layered continuous suture used to repair the uterine incision. The use of a hemostatic agent (Surgicel Nu-Knit Absorbable Hemostat, Ethicon) was mainly based on the presence of oozing from the incision site. The use of additional uterotonic medications other than oxytocin was noted. The uterotonic medications available were misoprostol, methylergonovine, and carboprost tromethamine.
Using the Kolmogorov-Smirnov test, we found that the data did not significantly deviate from normal distribution. Hence, we compared this variable using parametric tests, as appropriate. Comparisons were made using the independent t test. Categorical variables were expressed as number (%). The chi-square test or Fisher exact test was used to analyze categorical data, as appropriate; P < 0.05 was considered significant.
Time from the start of uterine repair until the attending surgeon called the end of uterine repair with no apparent bleeding from the incision site was recorded by a surgical nurse. Myometrial thicknesses at the incision were measured just before suturing began; we used a sterile disposable ruler to measure the length of the incision and maximal myometrial thickness to be able to assess these measurements as a potential confounding factor.
RESULTS
Ultrasound scans postoperatively were performed by a single specialist in the hospital obstetrics and gynaecology ultrasound unit. Scans were performed transabdominally (GE Voluson 730 expert, GE Healthcare, Chicago, IL) Secondary outcome measures were as follows: 1. Blood loss: a) Defined subjectively by the attending surgeon, taking into account the amount of blood in the suction canister and postoperative gauze count b) Defined objectively by the change in hemoglobin between preoperative and postoperative blood count tests 2. Need for additional hemostatic sutures other than the two-layered continuous suture for uterine repair 3. Total duration of surgery 4. Number and type of uterotonic agents 5. Hemostatic agents used during the surgery 6. Serious maternal morbidity (e.g., admission to intensive care unit) 7. Need for blood transfusion 8. Signs of wound infection as observed by a hospital physician or reported by patients 9. Uterine incision site hematoma, as measured by ultrasound scan on postoperative day 3.
Statistical Analysis
Statistical analysis was performed using SPSS software version 24 (IBM Corp., Armonk, NY). Continuous variables with a normal distribution are presented as mean § standard deviation.
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A total of 150 women were screened and 73 were randomized, as follows: 38 patients were randomized to a uterine repair with a two-layer technique using BKBS (group A), and in 35 patients we used polyglactin (group B); three patients from group A were excluded because of intervention unavailability at the time of surgery. A total of 70 participants were statistically analyzed for the primary outcome, as shown in the Figure. Maternal demographic, medical, and surgical characteristics were similar between groups (Table 1). The number of participants planned for a primary CS, first repeat CS, and second repeat CS was not significantly different between groups A and B (18 and 17, 13 and 10, four and eight, respectively). The most common reason for delivery by CS in both groups was a previous CS with refusal to attempt a trial of labour (34% and 37% in groups A and B, respectively). Antepartum and intrapartum characteristics were similar between the groups (Table 2). Uterine incision length in millimeters was similar in groups A and B (84.2 § 9.6 and 81.8 § 10.6, respectively). Maximal myometrial thickness in millimeters was not different between groups A and B (13.5 § 3.4 mm and 13 § 4.9 mm, respectively; P > 0.05). The primary outcome of time required to complete uterine repair was 308 § 57 seconds in group A and 411 § 74 seconds in group B (95% confidence interval 64.5−124.5; P < 0.001) (Table 3). When stratified according to only primary CS, the results were 282 § 49 seconds and 362 § 57 seconds (P < 0.001) for groups A and B, respectively. In repeat operations the results were 336 § 62 seconds and 432 § 78 seconds (P < 0.001) for groups A and B, respectively. Additional hemostatic sutures were used less frequently in group A versus group B (31% [11 of 35] vs. 71% [25 of 35]; RR 0.44; 95% confidence interval 0.25−0.74; P = 0.002). Hemostatic agents were also used less frequently in group A versus group B (11% [four of 35] vs, 34% [12 of 35]; RR 0.33; 95% confidence interval 0.11−0.93; P = 0.03). The total number of surgical procedures where additional uterotonic medications besides
Barbed Versus Conventional Suture for Uterine Repair During Caesarean Section
Table 1. Baseline demographics P value
BKBS group
Polyglactin group
Baseline characteristic
N = 35 (%)
N = 35(%)
Maternal age, mean § SD
32.4 § 5.4
32.9 § 6.1
0.6
3.1 § 2
2.9 § 1.2
0.56
Gravidity Parity
1.6 § 1.8
1.5 § 1
0.23
Body mass index, average § SD
30.7 § 5.9
32.6 § 6.4
0.15
<30 (%)
18 (51)
13 (37)
0.1
30−39.9 (%)
14 (40)
20 (57)
0.44
40−-49.9 (%)
3 (9)
2 (6)
0.8
0
18 (51)
17 (49)
0.8
1
13 (37)
10 (29)
0.4
2
4 (12)
8 (22)
0.2
Previous Caesarean deliveries (%)
Previous emergency Caesarean sections (%) Hemoglobin before surgery, average § SD
8 (22)
11 (31)
0.64
11.0 § 1.2
11.5 § 1.4
0.1
4 (15)
2 (8)
0.7
0
0
—
1 (4)
0
0.65
Medical history (%) Tobacco use Pre-gestational diabetes Chronic hypertension BKBS: bidirectional knotless barbed suture; SD: standard deviation.
Table 2. Antepartum and intrapartum characteristics Characteristics (%) Gestational age at delivery, mean § SD, weeks
BKBS group
Polyglactin group
38 § 2
38 § 2
1
0
0
2
P value 0.8
Gestational diabetes
3 (8)
2 (5)
0.64
Gestational hypertension
1 (2)
2 (5)
0.56
Group B Streptococcus colonization
2 (7)
0
0.4
3209 § 550
3070 § 653
0.3
12 (34)
13 (37)
0.15
Maternal request
4 (11)
5 (14)
0.69
Breech presentation
7 (20)
8 (23)
0.8
Suspected macrosomia
4 (12)
2 (6)
0.69
Multiple gestation
8 (23)
7 (20)
0.3
Maximal myometrial thickness (mm), mean § SD
13.5 § 3.4
13 § 4.9
0.63
Incision length (mm), mean § SD
84.2 § 9.6
81.8 § 10.6
0.34
Birth weight (g), mean § SD Indication for Caesarean delivery (%) Repeat Caesarean delivery
Uterine incision dimensions
BKBS: bidirectional knotless barbed suture; SD: standard deviation.
oxytocin were used was not significantly different between groups A and B (11 of 35 and 12 of 35, respectively; P = 0.8). Total surgery duration did not differ between the groups (33.4 § 8.8 minutes in group A vs. 33.2 § 7.5 in group B;
P > 0.05). Delta hemoglobin levels were not significantly different between groups A and B at intervals of 6, 18, and 72 hours postoperatively. The incidence of uterine incision site hematoma as measured by ultrasound scan on postoperative day 3 was nine of 35 and 10 of 35 cases in groups
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Table 3. Primary outcomes BKBS group N = 35 (%)
Polyglactin group N = 35 (%)
P value (95% CI)
Uterine repair time all cases (seconds)
308 § 57 (100)
411 § 74 (100)
<0.001a (64.5−124.5)
Uterine repair time primary CS (seconds)
282 § 49 (51)
362 § 57 (49)
<0.001a (43.5−116.5)
Uterine repair time repeat CS (seconds)
336 § 62 (49)
432 § 78 (51)
<0.001a (47.3−144.6)
Variable
a
BKBS: bidirectional knotless barbed suture; CI: confidence interval; CS: Caesarean section.
Table 4. Secondary outcomes BKBS group N = 35 (%)
Polyglactin group N = 35 (%)
P value (95% CI)
33.4 § 8.8
33.2 § 7.5
0.92 (¡4.1 to 3.7)
Additional hemostatic sutures (%)
11 (31)
25 (71)
0.002 (0.25−0.74)a
Use of hemostatic agents (n)
4 (11)
12 (34)
0.03 (0.11−0.93)a
Delta hemoglobin, 6 hours (mg/dL)
0.04 § 1.4
0.16 § 1.1
0.69 (¡0.48 to 0.72)
Delta hemoglobin, 18 hours (mg/dL)
0.38 § 1.4
0.71 § 1.3
0.3 (¡0.39 to 0.81)
Delta hemoglobin, 72 hours (mg/dL)
0.75 § 2.4
0.58 § 2
0.76 (¡0.28 to 0.65)
Estimated blood loss (mL)
Outcome Secondary outcomes Total surgery duration (minutes)
Blood loss parameters
735 § 248
704 § 168
0.54 (¡132.03 to 70.03)
Transfusion of packed cells (n)
1 (2)
0
0.68
Total additional uterotonics (n)
11 (31)
12 (34)
0.25 (0.46−1.79)
Methylergonovine (n)
5 (14)
8 (22)
0.36
Misoprostol (n)
8 (22)
4 (11)
0.21
Carboprost tromethamine (n)
3 (8)
0
0.18
Postoperative follow-up Uterine incision site hematoma incidence
a
9 (26)
10 (29)
0.27 (0.5−2.3)
Uterine incision site hematoma length (mm)
45 § 14.5
39 § 13.4
0.36 (¡19.5 to 7.5)
Uterine incision site hematoma width (mm)
14 § 7.7
17.7 § 11.5
0.41 (¡7.42 to 14.42)
Endometritis or wound infection (n)
0
0
—
Maternal morbidity (n)
0
0
—
BKBS: bidirectional knotless barbed suture; CI: confidence interval.
A and B, respectively (RR 0.9; 95% confidence interval 0.41−1.93; P > 0.78. The average size of incision site hematoma (length £ width) did not differ between the study and control groups (45 § 14.5 mm £ 14 § 7.7 mm and 39 § 13.4 mm £ 17.7 § 11.5 mm, respectively; P > 0.05). All other pre-specified secondary outcomes showed no significant differences (Table 4). DISCUSSION
In this randomized clinical trial involving women undergoing planned CS, we showed that the use of BKBS was effective in reducing the time required for repair of the
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uterine incision with fewer applications of additional sutures and hemostatic agents. However, total operative time was not significantly different. There was no difference in the rate of short-term complications between the traditional suture group and the barbed suture group. The BKBS provides key advantages over polyglactin. These include reduced suturing time by eliminating the need to tie surgical knots and better local hemostasis because of the barbed texture of BKBS and the fact it maintains tension on the suture line during suturing. We believe that those characteristics led to the results we found in our study.
Barbed Versus Conventional Suture for Uterine Repair During Caesarean Section
Our findings corroborate those of previous studies from the field of gynaecological laparoscopy10,11 and obstetric surgery,16,17 which reported similar advantages with the use of a barbed suture. The use of BKBS was associated with a reduction in operating time and an improvement in hemostasis.9−12,18−20 In corroboration of these findings, we found a reduction in the use of hemostatic agents in the BKBS group. This decline may reflect the advantage of a BKBS that maintains constant tension on the suture line and results in better control of bleeding from adjacent small blood vessels. We did not detect a significant difference in the total time of the operation. We suspect that this is because total surgery time is affected by multiple factors. These include, aside from uterine repair, the presence or absence of adhesions, the time needed to deliver the baby, and the time required for uterine contraction after delivery and closure of the fascia. Because the use of BKBS influences only uterine repair, its effect on the total surgery time could not be shown. The causes of hemorrhage in obstetric surgery are robust, and the main force that controls bleeding in obstetrics is proper contraction of the myometrium. Therefore, in contrast to the findings shown in gynaecological procedures,9,11,12 we did not demonstrate a difference in blood loss between the groups. The shorter uterine repair time did not translate to a decrease in blood loss, probably because of the minor contribution of this parameter relative to other factors such as uterine contraction.
However, in our study we found that the need for additional hemostatic sutures was significantly higher in the polyglactin group (Table 4). Postoperative bowel obstruction is one of the possible complications of CS. In the current series, we did not have any case with bowel obstruction in a short postoperative period. However, we agree that in future studies, the subject of bowel obstruction and severe intra-abdominal adhesions should be discussed. The strengths of our study include the randomized prospective methodology and the meticulous analysis of the surgical parameters. We accurately timed the stages of surgery, the use of uterotonic and hemostatic agents, delta hemoglobin in different intervals, and postoperative parameters including measurements of uterine incision site hematoma by ultrasound scan. Our main limitations were the inability to blind the surgeons to the intervention, thus resulting in potential user bias, and the inclusion of a heterogeneous population of patients with primary and repeat CS. We were able to show a significantly shorter uterine repair time in both primary and repeat CS using BKBS. We showed that the BKBS has some advantages over the standard suture, mainly reduced uterine closure time and, most importantly, no increase in short-term complications. CONCLUSION
We tried to evaluate the effect of the different sutures on uterine bleeding localized to the uterine incision site. On postoperative day 3, we performed an ultrasound scan to assess the presence or absence of uterine hematoma. We could not detect any difference between the groups in the incidence of cases with apparent hematoma or in hematoma size. An essential aspect of this finding is that although suturing the uterus was significantly faster with BKBS, it was not associated with an increased incidence of uterine incision site hematoma.
Although we were able to show a shorter uterine incision repair time with the novel barbed knotless suture compared with a standard smooth suture, it did not reduce total surgery time or blood loss. Further investigation in specific clinical conditions, including emergency CS, is warranted. The potential effect of the novel barbed suture on longterm outcomes including Caesarean scar defect and integrity during subsequent pregnancies is to be discovered in future studies.
Our study did not assess the potential effects of the BKBS on longer-term outcomes, such as functional integrity of the uterine scar during subsequent pregnancies, chronic pelvic pain, and infertility. To date, studies investigating long-term consequences have failed to demonstrate a clinically significant advantage of a particular technique that would result in better outcomes.3,21
Acknowledgements
The authors would like to thank the residents and midwives who assisted in patient recruitment and Mrs. Kremer for coordinating between the investigators and the staff of the labour and delivery department.
REFERENCES
In our study, we did not evaluate the cost-effectiveness of the BKBS. According to our department data, the price of one BKBS is equivalent to that of four polyglactin sutures.
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15. Kapustian V, Anteby EY, Gdalevich M, et al. Effect of closure versus nonclosure of peritoneum at cesarean section on adhesions: a prospective randomized study. Am J Obstet Gynecol 2012;206:56. e1−4. 16. Zayed MA, Fouda UM, Elsetohy KA, et al. Barbed sutures versus conventional sutures for uterine closure at cesarean section; a randomized controlled trial [e-pub ahead of print]. J Matern Fetal Neonatal Med doi:10.1080/14767058.2017.1388368, accessed February 18, 2018. 17. Peleg D, Ahmad RS, Warsof SL, et al. A randomized clinical trial of knotless barbed suture vs conventional suture for closure of the uterine incision at Cesarean delivery. Am J Obstet Gynecol 2018;218:343. e1−7. 18. Bogliolo S, Musacchi V, Dominoni M, et al. Barbed suture in minimally invasive hysterectomy: a systematic review and meta-analysis. Arch Gynecol Obstet 2015;292:489–97. 19. Tinelli R, Litta P, Angioni S, et al. A multicenter study comparing surgical outcomes and ultrasonographic evaluation of scarring after laparoscopic myomectomy with conventional versus barbed sutures. Int J Gynaecol Obstet 2016;134:18–21. 20. Manoucheri E, Einarsson JI. The use of barbed suture in hysterectomy and myomectomy. Surg Technol Int 2013;23:133–6. 21. Di Spiezio Sardo A, Saccone G, McCurdy R, et al. Risk of Cesarean scar defect following single- vs double-layer uterine closure: systematic review and meta-analysis of randomized controlled trials. Ultrasound Obstet Gynecol 2017;50:578–83.
Barbed Versus Conventional Suture for Uterine Repair During Caesarean Section: A Randomized Controlled Study Leonti Grin, MD; Ahmet Namazov, MD; Ale Ivshin, MD; Mark Rabinovich, MD; Victoria Shochat, MD; Simon Shenhav, MD; Ofer Gemer, MD; Efraim Zohav, MD; Eyal Y. Anteby, MD Department of Obstetrics and Gynecology, Barzilai University Medical Center, Faculty of Health Sciences, Ben-Gurion University of Negev, Ashkelon, Israel
Résumé L. Grin
Abstract Objective: This study sought to compare the short-term outcome of uterine incision repair during a Caesarean section (CS) using a bidirectional knotless barbed suture versus polyglactin suture. Methods: A randomized controlled trial was conducted at a university hospital. Participants undergoing a CS were randomized for uterine incision closure by bidirectional knotless barbed suture (group A) or polyglactin (group B). The primary outcome was the time needed to repair the uterine incision. The analysis was by intent to treat. A sample size of 35 per group (n = 70) was planned to detect a 30% reduction in uterine repair time (Canadian Task Force Classification I). Results: From July 2016 through October 2017, 150 women were screened, and 70 were statistically analyzed: group A (n = 35) and group B (n = 35). Time to complete uterine incision repair was 308 § 57 seconds for group A and 411 § 74 seconds for group B (P < 0.001). Total surgery time (33.4 § 8.8 minutes vs. 33.2 § 7.5 minutes; P = 0.64) was not significantly different between groups A and B, respectively. Conclusion: Repair of the CS uterine incision with barbed suture compared with polyglactin suture reduces suturing time.
Key Words: Caesarean section, uterine repair, barbed suture, postpartum hematoma, Caesarean section blood loss, C-section Corresponding author: Dr. Ahmet Namazov, Department of Obstetrics and Gynecology, Barzilai University Medical Center, Faculty of Health Sciences, Ben-Gurion University of Negev, Ashkelon, Israel. [email protected] This study is registered on ClinicalTrials.gov (Closing Uterine Incision During C-section Using Barbed Suture [Stratafix] or Vicryl Suture [NCT03159871]). Competing interests: The authors declare that they have no competing interests. Received on December 3, 2018 Accepted on January 7, 2019
tude cherchait a comparer les issues a court terme de Objectif : Cette e barbillons bidirectionnels sans nœud et de la suture de la suture a polyglactine pour la fermeture d’une incision chirurgicale durant une sarienne ce ae te mene dans un Méthodologie : Un essai clinique randomise ^pital universitaire. Les participantes qui subissaient une ho sarienne ont e te re parties ale atoirement en deux groupes pour la ce rine : suture a barbillons bidirectionnels fermeture de l’incision ute sans nœud (groupe A) ou suture de polyglactine (groupe B). L’issue tait le temps ne cessaire pour refermer l’incision ute rine. primaire e te effectue e. Un Une analyse selon l’intention de traiter a e chantillon de 35 patientes par groupe (n = 70) e tait pre vu pour e tecter une re duction de 30 % du temps de re paration de l’ute rus de tude canadien). (classification I du Groupe d’e Résultats : Entre juillet 2016 et octobre 2017, 150 femmes ont participe lection, et 70 ont fait l’objet d’une analyse au processus de se statistique dans les groupes A (n = 35) et B (n = 35). Le temps cessaire a la fermeture de l’incision ute rine e tait de 308 § 57 ne secondes pour le groupe A et de 411 § 74 secondes pour le groupe B rence significative dans la dure e totale de la (P < 0,001). Aucune diffe te observe e entre les groupes A et B, (33,4 § 8,8 chirurgie n’a e minutes contre 33,2 § 7,5 minutes, respectivement; P = 0,64). rine d’une ce sarienne est plus Conclusion : La fermeture de l’incision ute barbillons qu’avec une suture de polyglactine. rapide avec une suture a © 2019 The Society of Obstetricians and Gynaecologists of Canada/La Société des obstétriciens et gynécologues du Canada. Published by Elsevier Inc. All rights reserved.
J Obstet Gynaecol Can 2019;000(000):1−8 https://doi.org/10.1016/j.jogc.2019.01.011
INTRODUCTION
aesarean section (CS) is the most common abdominal surgical procedure performed in women worldwide.1,2 Nevertheless, there are numerous variations in the technical aspects of the operation.
C
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Uterine incision repair during a CS can be accomplished using a synthetic or catgut suture, with either single- or double-layer closure technique. There is currently a lack of evidence to recommend a particular technique or suturing material regarding short-term or long-term outcome.3−8 Surgeons most often choose the technique and suture on the basis of their personal experience and preference. With technological advances and given the increasing rates of CSs,2 exploration of novel techniques can lead to improvements in patient care. The bidirectional knotless barbed suture (BKBS) is a relatively new class of suture in obstetric surgery. It was introduced with the aim to reduce operative time and blood loss, and several studies in gynaecology showed a significant benefit with its use.9−13 The present study aimed to evaluate the role of BKBS for uterine incision repair during CS. In a prospective randomized trial, we compared two different suture materials used for a double-layer closure of the uterine incision with regard to the time needed to complete uterine repair and other short-term parameters. MATERIAL AND METHODS Study Design
This trial was conducted as a single university hospital, randomized controlled trial in accordance with the Consolidated Standards of Reporting Trials guidelines (Closing Uterine Incision During C-section Using Barbed Suture [Stratafix] or Vicryl Suture [NCT03159871]). We enrolled patients planned for delivery by a CS at our labour and delivery unit. Only patients planned for delivery by CS were approached for study participation. We included women who had no more than two previous deliveries by CS. All participants gave written informed consent before inclusion in the study. This study was approved by the Ethics Committee of our university hospital (BRZ 0018-16 CTIL; June 1, 2016). Sample Size
The sample size was calculated on the basis of the primary outcome measure, which was time needed to complete uterine incision repair. The average time for uterine closure in our department was calculated in patients who underwent elective CS (7 § 2.8 minutes); the sample size was calculated for a 30% reduction in time needed for uterine repair, with an alpha of 0.05 and a power of 80%. Given this calculation, the minimum sample size was 32 cases in each group (1:1 ratio of exposed to unexposed); a 10% rate of loss to follow-up was considered, yielding a total of 70 participants.
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Study Process
Study enrolment occurred between July 2016 and October 2017, and participants were followed up through November 2017. The data analysts, postpartum staff, and participants remained blinded to treatment allocation throughout the duration of the study. Surgeons were unmasked to randomization only after scrubbing for the surgery. Although the surgeons could not be blinded to the type of suture because of different appearances of these materials, neither the participants nor the experimenters who assessed the study results knew who received a particular suture. Of the 150 women undergoing a CS from July 2016 to October 2017 who were approached, 73 consented to participate and were randomly allocated to either group A or group B (Figure). Reasons for exclusion were lack of consent or an urgent CS not allowing time to elicit an informed consent, suspected placenta accreta, and a known blood clotting disorder. In group A, the uterine incision was repaired using a BKBS in a continuous two-layer technique. In group B, the uterine incision was repaired with polyglactin in a continuous two-layer technique. Three patients from group A were excluded because of unavailability of the intervention at the time of surgery. The randomization sequence was computer generated, and the principal investigator and co-investigators were responsible for enrolling participants and assigning participants to interventions. The surgical nurse was instructed to prepare either a tensile-strength size 1-0 absorbable BKBS (Stratafix Spiral PDO, Ethicon, Somerville, NJ) or polyglactin absorbable suture (Vicryl, Ethicon). The surgeon became aware of the type of suture only after the operation had begun, thus potentially eliminating patient selection bias. A total of three attending surgeons participated in the study. A standard technique was performed in all operations. The type of anaesthesia was chosen by the anaesthesiologist without reference to the treatment group. Surgical procedures were performed by an attending physician with a resident, who was aware of the nature of the study. All participants received chlorhexidine skin preparation unless there was a documented allergy, in which case povidone-iodine was used. Standard sterile draping of participants was performed. The abdomen was opened by a Pfannenstiel incision. After the transverse uterine incision in the lower uterine segment with the scalpel, the uterine incision was bluntly expanded. A
Barbed Versus Conventional Suture for Uterine Repair During Caesarean Section
Figure. Flow of participants in a trial of barbed versus polyglactin for uterine repair during a Caesarean section.
Enrollment
Assessed for eligibility (n = 150)
Excluded (n = 80) Not meeting inclusion criteria (n = 10) Refused to participate (n = 67)
Analysis
Follow up
Allocation
Randomized (n = 73)
Allocated to uterine repair with barbed suture, Group A (n=38) Did not receive allocated intervention (Due to intervention unavailability) (n=3 )
Allocated to uterine repair with a standard suture, Group B (n = 35) Did not receive allocated intervention (n=0)
Lost to follow up (n = 0)
Lost to follow up (n = 0)
Discontinued intervention (n = 0)
Discontinued intervention (n = 0)
Analyzed (n = 35)
Analyzed (n = 35)
transverse lower segment uterine incision was repaired with two layers of a continuous suture, and additional single figure-eight polyglactin sutures were applied to ensure hemostasis if required. In group A, BKBS was used in a two-layered, continuous, non-locking technique (according to the manufacturer’s instructions). In group B, polyglactin was used with a twolayered suture, the first layer a continuous locking and the second layer a continuous non-locking technique. Endometrium was included in the suture in both study and control groups. The visceral and parietal peritoneum was not re-approximated.8,14,15 The rectus fascia was closed with a
continuous non-locking technique. Rectus muscles were not closed. Subcutaneous tissue was sutured with interrupted absorbable sutures (polyglactin 2-0). The skin was approximated using staples. All patients received intraoperative prophylactic intravenous cefazolin (2 g). The patients were followed up during their hospital stay and until 30 days after the operation. A telephone questionnaire was used to assess the presence or absence of complications during convalescence. The two study arms were compared with regard to the primary outcome, which was the time required for uterine incision repair. We included both closure of the incision
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and additional sutures if performed. Additional sutures were noted when one or more extra sutures were applied in addition to the two-layered continuous suture used to repair the uterine incision. The use of a hemostatic agent (Surgicel Nu-Knit Absorbable Hemostat, Ethicon) was mainly based on the presence of oozing from the incision site. The use of additional uterotonic medications other than oxytocin was noted. The uterotonic medications available were misoprostol, methylergonovine, and carboprost tromethamine.
Using the Kolmogorov-Smirnov test, we found that the data did not significantly deviate from normal distribution. Hence, we compared this variable using parametric tests, as appropriate. Comparisons were made using the independent t test. Categorical variables were expressed as number (%). The chi-square test or Fisher exact test was used to analyze categorical data, as appropriate; P < 0.05 was considered significant.
Time from the start of uterine repair until the attending surgeon called the end of uterine repair with no apparent bleeding from the incision site was recorded by a surgical nurse. Myometrial thicknesses at the incision were measured just before suturing began; we used a sterile disposable ruler to measure the length of the incision and maximal myometrial thickness to be able to assess these measurements as a potential confounding factor.
RESULTS
Ultrasound scans postoperatively were performed by a single specialist in the hospital obstetrics and gynaecology ultrasound unit. Scans were performed transabdominally (GE Voluson 730 expert, GE Healthcare, Chicago, IL) Secondary outcome measures were as follows: 1. Blood loss: a) Defined subjectively by the attending surgeon, taking into account the amount of blood in the suction canister and postoperative gauze count b) Defined objectively by the change in hemoglobin between preoperative and postoperative blood count tests 2. Need for additional hemostatic sutures other than the two-layered continuous suture for uterine repair 3. Total duration of surgery 4. Number and type of uterotonic agents 5. Hemostatic agents used during the surgery 6. Serious maternal morbidity (e.g., admission to intensive care unit) 7. Need for blood transfusion 8. Signs of wound infection as observed by a hospital physician or reported by patients 9. Uterine incision site hematoma, as measured by ultrasound scan on postoperative day 3.
Statistical Analysis
Statistical analysis was performed using SPSS software version 24 (IBM Corp., Armonk, NY). Continuous variables with a normal distribution are presented as mean § standard deviation.
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A total of 150 women were screened and 73 were randomized, as follows: 38 patients were randomized to a uterine repair with a two-layer technique using BKBS (group A), and in 35 patients we used polyglactin (group B); three patients from group A were excluded because of intervention unavailability at the time of surgery. A total of 70 participants were statistically analyzed for the primary outcome, as shown in the Figure. Maternal demographic, medical, and surgical characteristics were similar between groups (Table 1). The number of participants planned for a primary CS, first repeat CS, and second repeat CS was not significantly different between groups A and B (18 and 17, 13 and 10, four and eight, respectively). The most common reason for delivery by CS in both groups was a previous CS with refusal to attempt a trial of labour (34% and 37% in groups A and B, respectively). Antepartum and intrapartum characteristics were similar between the groups (Table 2). Uterine incision length in millimeters was similar in groups A and B (84.2 § 9.6 and 81.8 § 10.6, respectively). Maximal myometrial thickness in millimeters was not different between groups A and B (13.5 § 3.4 mm and 13 § 4.9 mm, respectively; P > 0.05). The primary outcome of time required to complete uterine repair was 308 § 57 seconds in group A and 411 § 74 seconds in group B (95% confidence interval 64.5−124.5; P < 0.001) (Table 3). When stratified according to only primary CS, the results were 282 § 49 seconds and 362 § 57 seconds (P < 0.001) for groups A and B, respectively. In repeat operations the results were 336 § 62 seconds and 432 § 78 seconds (P < 0.001) for groups A and B, respectively. Additional hemostatic sutures were used less frequently in group A versus group B (31% [11 of 35] vs. 71% [25 of 35]; RR 0.44; 95% confidence interval 0.25−0.74; P = 0.002). Hemostatic agents were also used less frequently in group A versus group B (11% [four of 35] vs, 34% [12 of 35]; RR 0.33; 95% confidence interval 0.11−0.93; P = 0.03). The total number of surgical procedures where additional uterotonic medications besides
Barbed Versus Conventional Suture for Uterine Repair During Caesarean Section
Table 1. Baseline demographics P value
BKBS group
Polyglactin group
Baseline characteristic
N = 35 (%)
N = 35(%)
Maternal age, mean § SD
32.4 § 5.4
32.9 § 6.1
0.6
3.1 § 2
2.9 § 1.2
0.56
Gravidity Parity
1.6 § 1.8
1.5 § 1
0.23
Body mass index, average § SD
30.7 § 5.9
32.6 § 6.4
0.15
<30 (%)
18 (51)
13 (37)
0.1
30−39.9 (%)
14 (40)
20 (57)
0.44
40−-49.9 (%)
3 (9)
2 (6)
0.8
0
18 (51)
17 (49)
0.8
1
13 (37)
10 (29)
0.4
2
4 (12)
8 (22)
0.2
Previous Caesarean deliveries (%)
Previous emergency Caesarean sections (%) Hemoglobin before surgery, average § SD
8 (22)
11 (31)
0.64
11.0 § 1.2
11.5 § 1.4
0.1
4 (15)
2 (8)
0.7
0
0
—
1 (4)
0
0.65
Medical history (%) Tobacco use Pre-gestational diabetes Chronic hypertension BKBS: bidirectional knotless barbed suture; SD: standard deviation.
Table 2. Antepartum and intrapartum characteristics Characteristics (%) Gestational age at delivery, mean § SD, weeks
BKBS group
Polyglactin group
38 § 2
38 § 2
1
0
0
2
P value 0.8
Gestational diabetes
3 (8)
2 (5)
0.64
Gestational hypertension
1 (2)
2 (5)
0.56
Group B Streptococcus colonization
2 (7)
0
0.4
3209 § 550
3070 § 653
0.3
12 (34)
13 (37)
0.15
Maternal request
4 (11)
5 (14)
0.69
Breech presentation
7 (20)
8 (23)
0.8
Suspected macrosomia
4 (12)
2 (6)
0.69
Multiple gestation
8 (23)
7 (20)
0.3
Maximal myometrial thickness (mm), mean § SD
13.5 § 3.4
13 § 4.9
0.63
Incision length (mm), mean § SD
84.2 § 9.6
81.8 § 10.6
0.34
Birth weight (g), mean § SD Indication for Caesarean delivery (%) Repeat Caesarean delivery
Uterine incision dimensions
BKBS: bidirectional knotless barbed suture; SD: standard deviation.
oxytocin were used was not significantly different between groups A and B (11 of 35 and 12 of 35, respectively; P = 0.8). Total surgery duration did not differ between the groups (33.4 § 8.8 minutes in group A vs. 33.2 § 7.5 in group B;
P > 0.05). Delta hemoglobin levels were not significantly different between groups A and B at intervals of 6, 18, and 72 hours postoperatively. The incidence of uterine incision site hematoma as measured by ultrasound scan on postoperative day 3 was nine of 35 and 10 of 35 cases in groups
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Table 3. Primary outcomes BKBS group N = 35 (%)
Polyglactin group N = 35 (%)
P value (95% CI)
Uterine repair time all cases (seconds)
308 § 57 (100)
411 § 74 (100)
<0.001a (64.5−124.5)
Uterine repair time primary CS (seconds)
282 § 49 (51)
362 § 57 (49)
<0.001a (43.5−116.5)
Uterine repair time repeat CS (seconds)
336 § 62 (49)
432 § 78 (51)
<0.001a (47.3−144.6)
Variable
a
BKBS: bidirectional knotless barbed suture; CI: confidence interval; CS: Caesarean section.
Table 4. Secondary outcomes BKBS group N = 35 (%)
Polyglactin group N = 35 (%)
P value (95% CI)
33.4 § 8.8
33.2 § 7.5
0.92 (¡4.1 to 3.7)
Additional hemostatic sutures (%)
11 (31)
25 (71)
0.002 (0.25−0.74)a
Use of hemostatic agents (n)
4 (11)
12 (34)
0.03 (0.11−0.93)a
Delta hemoglobin, 6 hours (mg/dL)
0.04 § 1.4
0.16 § 1.1
0.69 (¡0.48 to 0.72)
Delta hemoglobin, 18 hours (mg/dL)
0.38 § 1.4
0.71 § 1.3
0.3 (¡0.39 to 0.81)
Delta hemoglobin, 72 hours (mg/dL)
0.75 § 2.4
0.58 § 2
0.76 (¡0.28 to 0.65)
Estimated blood loss (mL)
Outcome Secondary outcomes Total surgery duration (minutes)
Blood loss parameters
735 § 248
704 § 168
0.54 (¡132.03 to 70.03)
Transfusion of packed cells (n)
1 (2)
0
0.68
Total additional uterotonics (n)
11 (31)
12 (34)
0.25 (0.46−1.79)
Methylergonovine (n)
5 (14)
8 (22)
0.36
Misoprostol (n)
8 (22)
4 (11)
0.21
Carboprost tromethamine (n)
3 (8)
0
0.18
Postoperative follow-up Uterine incision site hematoma incidence
a
9 (26)
10 (29)
0.27 (0.5−2.3)
Uterine incision site hematoma length (mm)
45 § 14.5
39 § 13.4
0.36 (¡19.5 to 7.5)
Uterine incision site hematoma width (mm)
14 § 7.7
17.7 § 11.5
0.41 (¡7.42 to 14.42)
Endometritis or wound infection (n)
0
0
—
Maternal morbidity (n)
0
0
—
BKBS: bidirectional knotless barbed suture; CI: confidence interval.
A and B, respectively (RR 0.9; 95% confidence interval 0.41−1.93; P > 0.78. The average size of incision site hematoma (length £ width) did not differ between the study and control groups (45 § 14.5 mm £ 14 § 7.7 mm and 39 § 13.4 mm £ 17.7 § 11.5 mm, respectively; P > 0.05). All other pre-specified secondary outcomes showed no significant differences (Table 4). DISCUSSION
In this randomized clinical trial involving women undergoing planned CS, we showed that the use of BKBS was effective in reducing the time required for repair of the
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uterine incision with fewer applications of additional sutures and hemostatic agents. However, total operative time was not significantly different. There was no difference in the rate of short-term complications between the traditional suture group and the barbed suture group. The BKBS provides key advantages over polyglactin. These include reduced suturing time by eliminating the need to tie surgical knots and better local hemostasis because of the barbed texture of BKBS and the fact it maintains tension on the suture line during suturing. We believe that those characteristics led to the results we found in our study.
Barbed Versus Conventional Suture for Uterine Repair During Caesarean Section
Our findings corroborate those of previous studies from the field of gynaecological laparoscopy10,11 and obstetric surgery,16,17 which reported similar advantages with the use of a barbed suture. The use of BKBS was associated with a reduction in operating time and an improvement in hemostasis.9−12,18−20 In corroboration of these findings, we found a reduction in the use of hemostatic agents in the BKBS group. This decline may reflect the advantage of a BKBS that maintains constant tension on the suture line and results in better control of bleeding from adjacent small blood vessels. We did not detect a significant difference in the total time of the operation. We suspect that this is because total surgery time is affected by multiple factors. These include, aside from uterine repair, the presence or absence of adhesions, the time needed to deliver the baby, and the time required for uterine contraction after delivery and closure of the fascia. Because the use of BKBS influences only uterine repair, its effect on the total surgery time could not be shown. The causes of hemorrhage in obstetric surgery are robust, and the main force that controls bleeding in obstetrics is proper contraction of the myometrium. Therefore, in contrast to the findings shown in gynaecological procedures,9,11,12 we did not demonstrate a difference in blood loss between the groups. The shorter uterine repair time did not translate to a decrease in blood loss, probably because of the minor contribution of this parameter relative to other factors such as uterine contraction.
However, in our study we found that the need for additional hemostatic sutures was significantly higher in the polyglactin group (Table 4). Postoperative bowel obstruction is one of the possible complications of CS. In the current series, we did not have any case with bowel obstruction in a short postoperative period. However, we agree that in future studies, the subject of bowel obstruction and severe intra-abdominal adhesions should be discussed. The strengths of our study include the randomized prospective methodology and the meticulous analysis of the surgical parameters. We accurately timed the stages of surgery, the use of uterotonic and hemostatic agents, delta hemoglobin in different intervals, and postoperative parameters including measurements of uterine incision site hematoma by ultrasound scan. Our main limitations were the inability to blind the surgeons to the intervention, thus resulting in potential user bias, and the inclusion of a heterogeneous population of patients with primary and repeat CS. We were able to show a significantly shorter uterine repair time in both primary and repeat CS using BKBS. We showed that the BKBS has some advantages over the standard suture, mainly reduced uterine closure time and, most importantly, no increase in short-term complications. CONCLUSION
We tried to evaluate the effect of the different sutures on uterine bleeding localized to the uterine incision site. On postoperative day 3, we performed an ultrasound scan to assess the presence or absence of uterine hematoma. We could not detect any difference between the groups in the incidence of cases with apparent hematoma or in hematoma size. An essential aspect of this finding is that although suturing the uterus was significantly faster with BKBS, it was not associated with an increased incidence of uterine incision site hematoma.
Although we were able to show a shorter uterine incision repair time with the novel barbed knotless suture compared with a standard smooth suture, it did not reduce total surgery time or blood loss. Further investigation in specific clinical conditions, including emergency CS, is warranted. The potential effect of the novel barbed suture on longterm outcomes including Caesarean scar defect and integrity during subsequent pregnancies is to be discovered in future studies.
Our study did not assess the potential effects of the BKBS on longer-term outcomes, such as functional integrity of the uterine scar during subsequent pregnancies, chronic pelvic pain, and infertility. To date, studies investigating long-term consequences have failed to demonstrate a clinically significant advantage of a particular technique that would result in better outcomes.3,21
Acknowledgements
The authors would like to thank the residents and midwives who assisted in patient recruitment and Mrs. Kremer for coordinating between the investigators and the staff of the labour and delivery department.
REFERENCES
In our study, we did not evaluate the cost-effectiveness of the BKBS. According to our department data, the price of one BKBS is equivalent to that of four polyglactin sutures.
1. Lumbiganon P, Laopaiboon M, G€ulmezoglu AM, et al. Method of delivery and pregnancy outcomes in Asia: the WHO global survey on maternal and perinatal health 2007-08. Lancet 2010;375:490–9.
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2. Villar J, Valladares E, Wojdyla D, et al. Caesarean delivery rates and pregnancy outcomes: the 2005 WHO global survey on maternal and perinatal health in Latin America. Lancet 2006;367:1819–29.
13. Iavazzo C, Mamais I, Gkegkes ID. The role of knotless barbed suture in gynecologic surgery: systematic review and meta-analysis. Surg Innov 2015;22:528–39.
3. Abalos E, Addo V, Brocklehurst P, et al. Caesarean section surgical techniques: 3 year follow-up of the CORONIS fractional, factorial, unmasked, randomised controlled trial. Lancet 2016;388:62–72.
14. Anteby EY, Kruchkovich J, Kapustian V, et al. Short-term effects of closure versus non-closure of the visceral and parietal peritoneum at Cesarean section: a prospective randomized study. J Obstet Gynaecol Res 2009;35:1026–30.
4. Abalos E, Addo V, Brocklehurst P, et al. Caesarean section surgical techniques (CORONIS): a fractional, factorial, unmasked, randomised controlled trial. Lancet 2013;382:234–48. 5. Dodd JM, Anderson ER, Gates S, et al. Surgical techniques for uterine incision and uterine closure at the time of caesarean section. Cochrane Database Syst Rev 2014(7):CD004732. 6. Berghella V, Baxter JK, Chauhan SP. Evidence-based surgery for Cesarean delivery. Am J Obstet Gynecol 2005;193:1607–17. 7. Dahlke JD, Mendez-Figueroa H, Rouse DJ, et al. Evidence-based surgery for Cesarean delivery: an updated systematic review. Am J Obstet Gynecol 2013;209:294–306. 8. CAESAR Study Collaborative Group. Caesarean section surgical techniques: a randomised factorial trial (CAESAR). BJOG 2010;117:1366–76. 9. Zhang Y, Ma D, Li X, et al. Role of barbed sutures in repairing uterine wall defects in laparoscopic myomectomy: a systemic review and meta-analysis. J Minim Invasive Gynecol 2016;23:684–91. 10. Tulandi T, Einarsson JI. The use of barbed suture for laparoscopic hysterectomy and myomectomy: a systematic review and meta-analysis. J Minim Invasive Gynecol 2014;21:210–6. 11. Song T, Kim TJ, Kim WY, et al. Comparison of barbed suture versus traditional suture in laparoendoscopic single-site myomectomy. Eur J Obstet Gynecol Reprod Biol 2015;185:99–102. 12. Huang MC, Hsieh CH, Su TH, et al. Safety and efficacy of unidirectional barbed suture in mini-laparotomy myomectomy. Taiwan J Obstet Gynecol 2013;52:53–6.
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15. Kapustian V, Anteby EY, Gdalevich M, et al. Effect of closure versus nonclosure of peritoneum at cesarean section on adhesions: a prospective randomized study. Am J Obstet Gynecol 2012;206:56. e1−4. 16. Zayed MA, Fouda UM, Elsetohy KA, et al. Barbed sutures versus conventional sutures for uterine closure at cesarean section; a randomized controlled trial [e-pub ahead of print]. J Matern Fetal Neonatal Med doi:10.1080/14767058.2017.1388368, accessed February 18, 2018. 17. Peleg D, Ahmad RS, Warsof SL, et al. A randomized clinical trial of knotless barbed suture vs conventional suture for closure of the uterine incision at Cesarean delivery. Am J Obstet Gynecol 2018;218:343. e1−7. 18. Bogliolo S, Musacchi V, Dominoni M, et al. Barbed suture in minimally invasive hysterectomy: a systematic review and meta-analysis. Arch Gynecol Obstet 2015;292:489–97. 19. Tinelli R, Litta P, Angioni S, et al. A multicenter study comparing surgical outcomes and ultrasonographic evaluation of scarring after laparoscopic myomectomy with conventional versus barbed sutures. Int J Gynaecol Obstet 2016;134:18–21. 20. Manoucheri E, Einarsson JI. The use of barbed suture in hysterectomy and myomectomy. Surg Technol Int 2013;23:133–6. 21. Di Spiezio Sardo A, Saccone G, McCurdy R, et al. Risk of Cesarean scar defect following single- vs double-layer uterine closure: systematic review and meta-analysis of randomized controlled trials. Ultrasound Obstet Gynecol 2017;50:578–83.