Comparison of barbed suture versus traditional suture in laparoendoscopic single-site myomectomy

Comparison of barbed suture versus traditional suture in laparoendoscopic single-site myomectomy

European Journal of Obstetrics & Gynecology and Reproductive Biology 185 (2015) 99–102 Contents lists available at ScienceDirect European Journal of...

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European Journal of Obstetrics & Gynecology and Reproductive Biology 185 (2015) 99–102

Contents lists available at ScienceDirect

European Journal of Obstetrics & Gynecology and Reproductive Biology journal homepage: www.elsevier.com/locate/ejogrb

Comparison of barbed suture versus traditional suture in laparoendoscopic single-site myomectomy Taejong Song a,b,1, Tae-Joong Kim c,1, Woo Young Kim a, San-Hui Lee d,* a

Department of Obstetrics & Gynecology, Kangbuk Samsung Hospital, Sungkyunkwan University School of Medicine, Seoul, Republic of Korea Department of Obstetrics & Gynecology, CHA Gangnam Medical Center, CHA University, Seoul, Republic of Korea c Department of Obstetrics & Gynecology, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Republic of Korea d Department of Obstetrics & Gynecology, National Health Insurance Service Ilsan Hospital, Goyang, Republic of Korea b

A R T I C L E I N F O

A B S T R A C T

Article history: Received 5 August 2014 Received in revised form 6 November 2014 Accepted 17 November 2014

Objective: To compare the surgical outcomes between uterine wall repairs using barbed suture versus traditional suture during laparoendoscopic single-site myomectomy (LESS-M). Study design: Data were prospectively collected from 60 consecutive patients with uterine myomas at three institutions. Patients were managed by LESS-M with either traditional suture (the first 30 patients) or barbed suture (the next 30 patients). Operative time, blood loss, and technical difficulty were assessed for each patient. Results: Patient characteristics (age, body mass index, other demographic data, number of myomas, and location and size of the largest myoma) were similar between the two study groups. No significant differences in operative complications, failure rate of the intended surgeries, degree of postoperative pain, or hospital stay duration were observed between the two groups. The use of barbed suture significantly reduced the suturing time for treating the uterine wall defects (P = 0.014), as well as the total operative time (P = 0.027). The use of barbed suture was also associated with less operative blood loss (P = 0.040) and less technical difficulty (P = 0.001) compared with traditional suture. Conclusion: The use of barbed suture in LESS-M effectively reduces the time required for suturing, thereby decreasing the total operative time, the operative blood loss, and the surgical difficulty. ß 2014 Elsevier Ireland Ltd. All rights reserved.

Keywords: Myomectomy Barbed suture V-Loc Laparoendoscopic single-site Laparoscopy

Introduction Uterine myomas, also referred to as leiomyomas or fibroids, are very common tumors in women of childbearing age. Uterine myomas are clinically diagnosed in 20–50% of all women, with their incidence increasing in the later portion of a woman’s reproductive years [1]. Laparoscopic myomectomy is an established alternative to standard transabdominal myomectomy for managing uterine myomas, and is associated with significant advantages including less postoperative pain, shorter hospital stays, faster recoveries, and improved cosmetic satisfaction [2–7]. Recently, conventional laparoscopy with multiple trocars has been replaced by laparoendoscopic single-site (LESS) surgery, which has the advantage of improving the cosmetic results by reducing the

* Corresponding author at: Department of Obstetrics & Gynecology, National Health Insurance Service Ilsan Hospital, 1232 Baekseok 1-dong, Ilsandong-gu, Goyang 410-719, Republic of Korea. Tel.: +82 31 900 0218; fax: +82 31 900 0138. E-mail address: [email protected] (S.-H. Lee). 1 These authors have contributed equally to this paper. http://dx.doi.org/10.1016/j.ejogrb.2014.11.022 0301-2115/ß 2014 Elsevier Ireland Ltd. All rights reserved.

number of incisions [8–13]. However, LESS myomectomy (LESS-M) has not been widely performed due to its technical difficulties. In particular, laparoscopic suturing of uterine wall defects is one of the most difficult and time-consuming tasks when performing in LESS-M. Barbed suture is a new technology that has the potential to greatly facilitate laparoscopic suturing. Among the available equipment for barbed suture, the V-Loc wound closure device (Covidien, Mansfield, MA, USA) consists of a unilateral barbed absorbable thread, armed with a surgical needle at one end and a loop at the other end, which is used to secure the suture. The barb and loop ends allow the approximation of tissues without the need to tie surgical knots. Barbed suture has been used in a number of conventional laparoscopies using multiple trocars, including hysterectomies [14], myomectomies [15,16], colectomies [17], hernia repairs [18], and gastrointestinal anastomoses [19] with good results. However, the use of barbed suture has not yet been tested for LESS-M. Therefore, the aim of this study was to compare the surgical outcomes of barbed versus traditional suture in the repair of uterine wall defects during LESS-M.

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Materials and methods This is a cohort study including 60 consecutive patients who underwent LESS-M between February 2012 and April 2013 at three institutions (CHA, Gangnam Medical Center, Seoul, Republic of Korea; National Health Insurance Service Ilsan Hospital, Goyang, Republic of Korea; Samsung Medical Center, Seoul, Republic of Korea). Data for the first 30 patients, who underwent LESS-M using traditional intracorporeal suture, were compared with data for the next 30 patients, who underwent LESS-M using an absorbable unidirectional knotless barbed suture device to repair the uterine wall defects. After institutional review board approval had been obtained for this study, all patients gave written informed consent for their data to be analyzed prospectively. All patients underwent transvaginal and/or transabdominal ultrasonography within 30 days before surgery, in which the number, sizes, and locations of the myomas were assessed and recorded. The inclusion criteria for this study included: women with myomas causing symptoms such as menorrhagia, pelvic pressure/pain, or infertility; women who were planning to undergo laparoscopic myomectomy; women who had 3 myomas, with the largest myoma 12 cm; women who were not pregnant at the time of presentation; and women between 18 and 55 years of age. Exclusion criteria included: women with a dominant pedunculated subserosal or submucosal type myoma; women who underwent concomitant complex surgical procedures at the time of laparoscopic myomectomy, such as severe adhesiolysis or resection for severe endometriosis; women with any suggestion of malignant uterine or adnexal diseases; women with major medical comorbidities or psychiatric illnesses, which could affect follow-up and/or compliance; and women who refused to participate or give consent to the procedures. One surgeon from each participating institution performed all the surgeries at that institution. All participating surgeons had comparable surgical skills and a preference for LESS surgery. After the introduction of general anesthesia, patients were placed in the Trendelenburg position, and a single multi-channel port was inserted through the umbilicus. The use of various ports and laparoscopic instruments was allowed during the LESS-M procedures, based on each surgeon’s preference. Before initiating the uterine incision, a local vasoconstrictor such as dilute vasopressin was injected into the serosal and/or overlying myometrium, and just around the myoma, to reduce blood loss. Using a Harmonic Scalpel (Ethicon Endo-surgery, Cincinnati, OH, USA) or a SonoSurge (Olympus Medical, Tokyo, Japan), a longitudinal myometrial incision was made over the myoma. After identifying the cleavage plane, the myoma was enucleated by means of adequate traction with a laparoscopic myoma screw or forceps. Coagulation of significant bleeding was obtained with bipolar forceps. In the traditional suture group, myometrial closure was performed in one to two layers, depending on their size and depth. Closure was performed in a continuous manner with Vicryl 1-0 sutures (Ethicon, Somerville, NJ, USA), using intracorporeal knots to secure each suture end. In the barbed suture group, myometrial closure was performed in a single or double layer. Closure was performed using a 30-cm 1-0 polyglyconate unidirectional barbed suture with a 37-mm half circle taper-point needle (V-Loc 180; Covidien). The first stitch was locked by a loop at one end of the uterine incision, and then a continuous suture was passed through to the opposite end of the uterine incision and cut without tying a knot. The myomas, which were placed into the specimen retrieval endopouch, were removed transumbilically with a knife morcellation protected with a wound retractor connected to a single-port system. On occasion, the myomas were removed with an electrosurgical morcellator (Wisap, Sauerlach-Munchen, Germany) through the 10-mm channel of the umbilical port. The procedure

was completed by establishing control of uterine hemostasis, washing the pelvic cavity, and absorbing any clots that had formed. A specific form was designed to prospectively collect data concerning patient characteristics, intraoperative details, surgical outcomes, and perioperative complications. The total operative time, which was electronically recorded, was defined as the time from skin incision to skin closure. The times required to perform each phase, including the enucleation time for all myomas, the suturing time for all uterine wall defects, and the morcellation times, were measured and calculated with the digital time counter. Operative blood loss was calculated by the anesthesiology unit as the difference between the total amount of suction and irrigation plus the difference between the total gauze weight before and after surgery. Failure of the intended operation was defined as the use of one or more additional ports (entailing a conversion to conventional laparoscopy using multiple ports) and conversion to laparotomy. At the end of each operation, the degree of total surgical difficulty, enucleation difficulty, and suturing difficulty were evaluated by the operator using a visual analog scale (VAS) varying from 1 (low difficulty) to 10 (high difficulty), as described by Vassiliou et al. [20]. Postoperative pain assessments were performed using a VAS at 12, 24, and 48 h postsurgery by several assessors who were not associated with the investigators. The scale was presented as a 10-cm line with verbal descriptors indicating ‘‘no pain’’ and ‘‘pain as bad as it could be’’. In both groups, a blood sample was taken within 24 h after surgery. The hemoglobin change was defined as the difference between the preoperative hemoglobin level and the hemoglobin level on postoperative day 1. Patients were discharged from the hospital after restoration of bowel activity, successful ambulation, the absence of postoperative fever, and when they no longer needed narcotic analgesics. The length of the hospital stay was defined as the time from the operation day to the day of discharge. All intraoperative and postoperative complications arising within 30 days of the surgery were recorded. All patients were scheduled for follow-up examinations at 1 week and 1 month postsurgery. All statistical analyses were performed using SPSS 13.0 (SPSS Inc., Chicago, IL, USA). Data are presented as means  standard deviation (SD) or medians (range) for continuous variables, and frequencies (percentages) for categorical variables. Baseline clinical characteristics and study outcomes were compared between the two groups using Student’s t-test or the Mann–Whitney test for continuous variables, and the chi-squared test or Fisher’s exact test for categorical variables, as appropriate. P-values < 0.05 were considered to be statistically significant. Results Baseline characteristics including age, body mass index, marital status, parity, menopausal status, abdominal surgical history, and preoperative hemoglobin concentration were similar between the two study groups (Table 1). The mean age and body mass index of the study patients were 39.2  5.4 years and 22.0  3.3 kg/m2, respectively. The main indication for myomectomy, number of uterine myomas, and diameter and location of the largest myoma also did not differ between the two groups (P > 0.05 for all). The surgical outcomes of each group are shown in Table 2. The median operative time for the entire surgical procedure was shorter in the barbed suture group than in the traditional suture group (69 min [25–215 min] versus 91 min [32–218 min], P = 0.027). The time required for uterine defect suturing was also shorter in the barbed suture group than in the traditional suture group (19 min [6–65 min] versus 27 min [9–100 min], P = 0.014). However, no differences were observed between the groups for the other operative time segments, including myoma enucleation time and morcellation time. The degree of surgical difficulty for the overall procedure and the uterine defect suturing were lower in the

T. Song et al. / European Journal of Obstetrics & Gynecology and Reproductive Biology 185 (2015) 99–102 Table 1 Patient baseline characteristics.

Age (years) Body mass index (kg/m2) Parity Nulliparous Parous Married Menopause History of abdominal surgery Preoperative hemoglobin (mg/dL) Main indication for myomectomy Pelvic pain or pressure Abnormal uterine bleeding Rapid growing or infertility Number of uterine myomas Diameter of largest myoma (cm) Location of largest myoma Anterior Posterior Lateral or fundal Adhesiolysis

Traditional suture in LESS-M (n = 30)

Barbed suture in LESS-M (n = 30)

P-value

39.8  5.0 21.7  3.3

38.6  5.7 22.3  3.2

0.377 0.530 0.559

7 (23%) 23 (77%) 3 (10%) 2 (7%) 8 (27%) 12.6  1.3

9 (30%) 21 (75%) 3 (10%) 0 8 (27%) 12.4  1.4

14 (47%) 6 (20%) 10 (33%) 1 (1–3) 6.4  1.9

15 (50%) 8 (27%) 7 (23%) 1 (1–3) 6.8  1.9

14 12 4 2

10 12 8 1

(47%) (40%) (13%) (7%)

(33%) (40%) (27%) (3%)

>0.999 0.246 >0.999 0.698 0.654

0.724 0.468 0.368

>0.999

LESS-M, laparoendoscopic single-site myomectomy. Data are expressed as the means  SD, medians (range), or frequencies (percentages), as appropriate.

barbed suture group than in the traditional suture group (P = 0.001 and P < 0.001, respectively), while the degree of surgical difficulty for myoma enucleation was similar between the two groups (P = 0.756). When subgroup analyses were conducted by confining them to women who had the largest myoma >6 cm, the results remained unchanged. The amount of operative blood loss was also lower in the barbed suture group than in the traditional suture group (145 mL [40–350 mL] versus 100 mL [15–450 mL], P = 0.040). The change in hemoglobin levels in the barbed suture group seemed to be lower than in the traditional suture group (1.7  1.8 mg/dL versus 2.2  0.9 mg/dL), although this difference did Table 2 Surgical results. Traditional suture in LESS-M (n = 30) Operative time (min) Total operative time Myoma enucleation time Suturing time Morcellation time Degree of surgical fatiguea Overall procedure Myoma enucleation Suturing Operative blood loss (mL) Hemoglobin change (mg/dL) Transfusion Failure of intended surgery Conversion to multi-port oneb Conversion to laparotomy Postoperative pain score At 12-h postsurgery At 24-h postsurgery At 48-h postsurgery Length of hospital stay (days) Operative complications Intraoperative complications Postoperative complications

91 20 27 13

(32–218) (5–71) (9–100) (1–43)

7 (2–10) 5 (1–10) 7 (1–10) 145 (40–350) 2.2  0.9 2 (7%) 2 (7%) 0 2 (7%) 3 3 2 3 0 0 0

(3–6) (2–4) (1–6) (2–5)

Barbed suture in LESS-M (n = 30) 69 22 19 12

P-value

(25–215) (5–68) (6–65) (1–62)

0.027 0.894 0.014 0.917

4 (2–10) 5 (1–10) 4 (2–10) 100 (15–450) 1.7  1.8 1 (3%) 0 0 0

0.001 0.756 <0.001 0.040 0.061 >0.999 0.246

3 3 2 3 0 0 0

(2–8) (1–5) (0–6) (2–5)

0.430 0.329 0.364 0.563 >0.999

a The degree of surgical difficulty was evaluated subjectively by the operator using a visual analog scale ranging from 1 (low difficulty) to 10 (high difficulty). b Indicates that the use of additional port or ports was needed.

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not reach a statistical significance (P = 0.061). Regarding the failure rate of intended LESS-M, two procedures failed in the traditional suture group, whereas no failures occurred in the barbed suture group. Conversion to laparotomy was needed in two cases of the traditional suture group, in order to promptly control severe uterine hemorrhage. Transfusion rates, postoperative pain scores, and the lengths of hospital stay did not differ between the study groups. During the follow-up period, no significant intraoperative or postoperative complications developed in either group. Comments In this multicenter study, we prospectively collected and analyzed data regarding the experiences of three surgeons who performed LESS-M on a total of 60 consecutive patients. No complications occurred in either the traditional suture group or the barbed suture group. However, the use of barbed suture effectively reduced the time required for suturing, thereby reducing the total operative time, the total amount of operative blood loss, and the surgical difficulty of the procedure. To the best of our knowledge, this is the first study to compare the surgical outcomes of barbed suture versus traditional suture in LESS-M. As surgeons seek more time-effective and labor-effective surgical methods, we are confident that barbed suture will be received as a promising technique for the laparoscopic suturing in LESS-M, based on the results presented here. Laparoscopic suturing is widely considered to be one of the most difficult and time-consuming tasks performed during laparoscopy. The main reason why laparoscopic suturing is so difficult is that multiple sutures must be tied in a confined cavity with limited visibility. These limitations are even more pronounced in LESS surgery, due to the even narrower range of movement and the frequent clashing between instruments. Therefore, in order to avoid the technical difficulties that often accompany intracorporeal suturing of the uterine wall defects during LESS-M, alternative methods have been developed. These alternative methods include the use of a Hem-o-lock ligation clip [8], the generation of uterine traction with extracorporeal multi-directional stitches [21], and the use of an extracorporeal knot-pusher device [22]. Here, we provide new evidence that the repair of uterine wall defects with barbed suture is efficient when performing LESS-M. In this study, the suturing time for uterine wall defects was shorter in the barbed suture group than in the traditional suture group (P = 0.014). Moreover, the degree of surgical difficulty for uterine defect suturing was also lower in the barbed suture group than in the traditional suture group (P < 0.001). These results are consistent with those presented in a study of LESS-total laparoscopic hysterectomy (TLH) [23], in which the use of barbed suture in LESS-TLH was associated with a shorter suturing time (P < 0.001) and less technical difficulty (P < 0.001). Even in conventional laparoscopic myomectomy using multiple trocars, the use of barbed suture has been shown to reduce the time required to suture the uterine wall defect (P < 0.001) and the amount of the intraoperative blood loss (P < 0.001) when compared with traditional suture [15]. Taken together, these data indicate that the use of barbed suture helps surgeons to facilitate suturing by providing an even distribution of tensile strength throughout the repair procedure [24–26]. As previously reported [15], one major limitation of increasing the implementation of barbed suture is that this technique is more expensive than traditional suture; however, the reduction in surgical time may compensate for this increased cost. This idea is supported by a report by Massoud et al. [27], who performed a costeffectiveness analysis of robotic-assisted radical prostatectomy using unidirectional barbed suture compared with traditional suture and found the former to be more economical.

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Fig. 1. Surgical techniques did not improve as the study progressed.

This study had some limitations. First, the study had a nonrandomized comparative design, and patient data collected during two different study periods were compared. Thus, it is possible that surgical technique improved as the study progressed, which could potentially have introduced a ‘‘practice effect’’ into the results. However, the operator at each institution had extensive experience in performing LESS-M before the commencement of this study, and thus it is unlikely that substantial improvements in surgical technique would have occurred. In support of this idea, no differences were observed between the two study groups in terms of other operative time segments such as myoma enucleation time and morcellation time; the only difference observed was in the suturing time. Furthermore, Spearman correlation analysis revealed no significant correlation of operative experience over time affecting the results (Fig. 1). Second, a larger sample size would have facilitated a better evaluation of operative complications; moreover, long-term follow-up data would have provided more information about results of LESS surgery. Meanwhile, the strength of this study is that the procedures were performed by multiple surgeons in multiple institutions; thus, our results may easily be applicable to other surgeons. In conclusion, the use of barbed suture in LESS-M was associated with a shorter operative time, less operative blood loss, and reduced technical difficulty. Since LESS surgery is challenging for surgeons and requires high degree of skill and ambidexterity, our results will potentially benefit all surgeons interested in performing minimally invasive surgical procedures. References [1] Sami Walid M, Heaton RL. The role of laparoscopic myomectomy in the management of uterine fibroids. Curr Opin Obstet Gynecol 2011;23:273–7. [2] Alessandri F, Lijoi D, Mistrangelo E, Ferrero S, Ragni N. Randomized study of laparoscopic versus minilaparotomic myomectomy for uterine myomas. J Minim Invasive Gynecol 2006;13:92–7. [3] Holzer A, Jirecek ST, Illievich UM, Huber J, Wenzl RJ. Laparoscopic versus open myomectomy: a double-blind study to evaluate postoperative pain. Anesth Analg 2006;102:1480–4. [4] Jin C, Hu Y, Chen XC, et al. Laparoscopic versus open myomectomy—a metaanalysis of randomized controlled trials. Eur J Obstet Gynecol Reprod Biol 2009;145:14–21. [5] Mais V, Ajossa S, Guerriero S, Mascia M, Solla E, Melis GB. Laparoscopic versus abdominal myomectomy: a prospective, randomized trial to evaluate benefits in early outcome. Am J Obstet Gynecol 1996;174:654–8. [6] Palomba S, Zupi E, Russo T, et al. A multicenter randomized, controlled study comparing laparoscopic versus minilaparotomic myomectomy: short-term outcomes. Fertil Steril 2007;88:942–51.

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