Use of Bidirectional Barbed Suture in Laparoscopic Myomectomy: Evaluation of Perioperative Outcomes, Safety, and Efficacy

Use of Bidirectional Barbed Suture in Laparoscopic Myomectomy: Evaluation of Perioperative Outcomes, Safety, and Efficacy

Original Article Use of Bidirectional Barbed Suture in Laparoscopic Myomectomy: Evaluation of Perioperative Outcomes, Safety, and Efficacy J. I. Eina...

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Original Article

Use of Bidirectional Barbed Suture in Laparoscopic Myomectomy: Evaluation of Perioperative Outcomes, Safety, and Efficacy J. I. Einarsson, MD, MPH*, N. R. Chavan, MBBS, MPH, Y. Suzuki, MD, MPH, G. Jonsdottir, T. T. Vellinga, MD, and J. A. Greenberg, MD From the Department of Obstetrics and Gynecology, Brigham and Women’s Hospital, Boston, Massachusetts (all authors).

ABSTRACT Study Objective: To compare perioperative outcomes during laparoscopic myomectomy using a bidirectional barbed suture vs conventional smooth suture. Design: Retrospective analysis of 138 consecutive laparoscopic myomectomies performed by a single surgeon over 3 years (Canadian Task Force classification II-2). Setting: Major university teaching hospital. Patients: One hundred thirty-eight women with symptomatic uterine myomas. Interventions: In women undergoing laparoscopic myomectomy from February 2007 through April 2010, conventional smooth sutures were used in 31 patients, and bidirectional barbed suture in 107 patients. Measurements and Main Results: The primary indications for laparoscopic myomectomy in either group were pelvic pain or pressure and abnormal uterine bleeding. Use of bidirectional barbed suture was found to significantly shorten the mean (SD) duration of surgery (118 [53] minutes vs 162 [69] minutes; p ,.05) and reduce the duration of hospital stay (0.58 [0.46] days vs 0.97 [0.45] days; p ,.05). No significant differences were observed between the 2 groups insofar as incidence of perioperative complications, estimated blood loss, and number or weight of myomas removed during surgery. Conclusion: Use of bidirectional barbed suture seems to facilitate closure of the hysterotomy site in laparoscopic myomectomy. Journal of Minimally Invasive Gynecology (2011) 18, 92–95 Ó 2010 AAGL. All rights reserved. Keywords:

Barbed; Laparoscopic; Myomectomy; Suture

Barbed suture is a relatively new concept in gynecologic surgery. The Quill bidirectional barbed suture (Angiotech Pharmaceuticals, Inc., Vancouver, BC, Canada) was approved by the US Food and Drug Administration for soft tissue approximation in 2004 [1], and has been commercially available in the United States since 2007. Bidirectional barbed sutures are created by cutting barbs into the suture with the barbs facing in a direction opposite that of the needle. The barbs change direction at the midpoint of the suture [2], and needles are swaged onto both ends of the suture. Because of its decreased effective diameter, barbed suture is rated 1 suture size greater than smooth suture; for example, a 0 barbed suture equals a 2-0 smooth The authors have no commercial, proprietary, or financial interest in the products or companies described in this article. Corresponding author: J. I. Einarsson, MD, MPH, Brigham and Women’s Hospital, 75 Francis St, ASB 1-3, Boston, MA 02115. E-mail: [email protected] Submitted July 30, 2010. Accepted for publication October 7, 2010. Available at www.sciencedirect.com and www.jmig.org 1553-4650/$ - see front matter Ó 2010 AAGL. All rights reserved. doi:10.1016/j.jmig.2010.10.003

suture. The anchoring of bidirectional barbed suture resists migration and can be conceptualized as a ‘‘continuous interrupted’’ suture without knots, and has at least equal tissueholding performance as comparable knot anchored suture [3,4]. This offers several advantages. Because bidirectional barbed sutures self-anchor and are balanced by the countervailing barbs, no knots are required. Furthermore, barbed suture self-anchors at every 1 mm of tissue, yielding more consistent wound apposition. Knotless barbed suture can securely reapproximate tissues with less time, cost, and aggravation [5,6]. We began using the Quill bidirectional barbed suture (Angiotech Pharmaceuticals, Inc.) in March 2008 [6], and since then have used this material in more than 300 laparoscopic procedures, primarily laparoscopic myomectomy and laparoscopic total hysterectomy. Inasmuch as the application of bidirectional barbed suture is fairly new in gynecologic endoscopy, we compared perioperative outcomes in our patients who underwent myomectomy before and after implementation of barbed suture in our laparoscopic procedures. The primary outcome measure was operating time, and secondary outcome measures included

Einarsson et al.

Barbed Suture for Laparoscopic Myomectomy

perioperative outcomes such as estimated blood loss, hospital length of stay, and perioperative complication rates. Materials and Methods This was a retrospective cohort study of 138 consecutive patients who underwent laparoscopic myomectomy from February 2007 through April 2010. The last 31 patients who underwent laparoscopic myomectomy using traditional smooth suture were compared with the next 107 consecutive patients who underwent laparoscopic myomectomy using bidirectional barbed suture for hysterotomy closure. In brief, the laparoscopic myomectomy technique was as follows. In general, an umbilical camera port and 2 parallel operative ports on the left side are used. A third operative port may be used on the right side if required. The uterus is infiltrated with dilute vasopressin, 20 U in 60 mL of saline solution, taking care to use no more than 10 U each time [7]. We generally prefer to create a horizontal incision into the uterus using the Harmonic Scalpel (Ethicon Endo-Surgery, Cincinnati, OH). The myoma is then dissected out of the uterus with generous traction with a tenaculum and countertraction with an atraumatic grasper as well as the Harmonic Scalpel, as needed. In case of inadvertent entry into the uterine cavity, the endometrial defect is closed with a running 2-0 polyglactin 910 suture, taking care to avert suture entry into the uterine cavity. Before implementation of barbed suture, we used 2/0 polydioxanone suture on a CT-1 needle in continuous fashion using intracorporeal knot tying to secure each end of the suture. The hysterotomy was closed in as many layers as necessary to eliminate dead space in the myometrial defect. After converting to barbed suture, the hysterotomy has been closed in layers using a 14 ! 14-cm 0 polydioxanone suture on a 36-mm half-circle tapered needle. If the hysterotomy is longer than 8 cm, the 24 ! 24-cm suture is preferred. Tacking the first needle to the opposite anterior abdominal wall helps to prevent suture tangling. The deepest layer is closed using the first needle, and the second needle is used to close the more superficial layer and the serosa if possible. The needles are cut, and a LapraTy clip can be applied if the suture is used beyond the barbed portion of the suture, although additional anchoring of barbed sutures in not generally needed or recommended. Sometimes 3 or 4 layers are needed to close a deep myometrial defect. 2/0 Glycolide and e-caprolactone (Monoderm) can also be used for the serosa, either continuously or using a baseball stitch. The hysterotomy site is generally covered with an adhesion barrier (Interceed; Ethicon, Inc., Sommerville, NJ). Patients were generally discharged to home on the day of surgery or the following day, and were seen in the office for a postoperative visit 3 to 4 weeks after surgery. All procedures were either performed or supervised by the same surgeon (J.I.E.). In many instances, residents or fellows acted as the primary surgeon for a large portion of the procedure, including suturing of the hysterotomy site. The study was reviewed and approved by the Partners Internal Review Board.

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To our knowledge, there are no previous analytical studies available that compare perioperative outcomes using smooth vs bidirectional barbed sutures. Therefore, we extrapolated the mean (SD) observed in our cohorts to identify that a minimum sample size of 31 patients is required to achieve a power of 80% in detecting a statistically significant difference, at a 95% confidence level (STATA version 10.0; StataCorp LP, College Station, TX) for the perioperative outcomes under study; specifically for the duration of surgery and length of hospital stay. Data were analyzed using the Fisher exact test and c2 test for categorical variables, and the t test for continuous variables. All p values were 2-sided, and p ,.05 was considered statistically significant. Results Patient demographic data are given in Table 1. The most common indications for surgery were pelvic pain or pressure and abnormal uterine bleeding. Perioperative outcomes between the traditional suture group vs the bidirectional barbed suture group are given in Table 2. Total operative time was significantly shorter after implementation of barbed suture for hysterotomy closure, and hospital stay was also significantly shorter. There were no significant differences in estimated blood loss, number of myomas removed, or weight of myomas removed. These results were unchanged when the cohort of patients undergoing laparoscopic myomectomy Table 1

Patient demographic dataa Variable

Before Quill Suture (n 5 31)

After Quill Suture (n 5 107) p Value

Age, y Mean (SD) 37.97 (7.45) 39.31 (7.59) .39 Median (range) 37 (26–54) 39 (25–55) Body mass index Mean (SD) 25.86 (5.16) 25.45 (6.04) .79 Median (range) 24.7 (19.9–38.2) 23.85 (16.6–47.3) Race/ethnicityb White 10 (32.26) 47 (65.28) ,.001 African American 8 (25.81) 17 (23.61) Hispanic 8 (25.81) 0 Asian 2 (6.45) 6 (8.33) Other 3 (9.68) 2 (2.78) Premenopausal 29 (93.55) 102 (95.33) .50 Smoker 1 (3.23) 5 (4.67) .59 Previous laparoscopy 6 (9.35) 20 (18.69) .56 Previous laparotomy 9 (29.03) 30 (28.04) .54 Indication for myomectomy Pelvic pain or pressure 30 (96.77) 81 (75.70) .005 Infertility 2 (6.45) 7 (6.54) .67 Abnormal uterine 11 (35.48) 41 (38.32) .77 bleeding Urinary frequency 1 (3.23) 11 (10.28) .20 Dyspareunia 1 (3.23) 5 (4.67) .59 Menorrhagia 3 (9.68) 13 (12.15) .50 a

Unless otherwise indicated, values are given as No. (%). Comparison between 31 procedures before Quill suture use and 72 procedures after Quill suture use. b

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Journal of Minimally Invasive Gynecology, Vol 18, No 1, January/February 2011

Table 2

Table 4

Perioperative outcome after laparoscopic myomectomya

Overall incidence of complicationsa

Variable

Before Quill Suture (n 5 31)

After Quill Suture (n 5 107)

Duration of surgery, min

161.19 (68.57) 117.58 (52.63) 166 (50–289) 106 (27–335) Estimated blood loss, mL 140 (127.64) 154.17 (244.39) 100 (30–700) 50 (20–1200) No. of myomas removed 4.3 (5.04) 3.38 (3.71) 3 (1–21) 2 (1–21) Myoma weight, g 23.7 (191.15) 287.89 (294.68) 170.5 (54–814) 234 (10–2012) Hospital stay, d 0.97 (0.42) 0.58 (0.46) 1 (0.5–2.0) 0.5 (0–2) a

p Value

Complication

.003

Intraoperative Postoperative Incision site infection Urinary tract infection Ileus Blood transfusion

.76 .27 .40

using the conventional smooth sutures were compared with the first 31 patients (equal treatment-specific sample sizes) who underwent laparoscopic myomectomy using the bidirectional barbed suture (Table 3). The incidence of complications between the 2 groups is compared in Table 4. There were no conversions to laparotomy in either group, and no significant differences in complication rates were observed between the 2 cohorts.

Discussion In the present study, use of bidirectional barbed suture for hysterotomy closure at laparoscopic myomectomy significantly shortened total operative time. This was confirmed in both the original analysis of the 107 procedures using the bidirectional barbed suture and in the subgroup analysis, focusing on the first 31 procedures in which this surgical technique was used. In our clinical experience, use of barbed suture virtually eliminates backsliding of the suture, which greatly facilitates myometrial closure. We did not observe any increase in complications in this consecutive series of 107 procedures using barbed suture, which includes the first cases in our practice in which this suture material was used. However, given the low Table 3

Perioperative outcome after laparoscopic myomectomy: comparison between last 31 procedures using smooth suture and first 31 procedures using bidirectional barbed suturea Before Quill Suture (n 5 31)

After Quill Suture (n 5 31)

Duration of surgery, min

161.19 (68.57) 121.9 (51.35) 166 (50–289) 111 (27–252) Estimated blood loss, mL 140 (127.64) 111.3 (218.39) 100 (30–700) 50 (20–1200) No. of myomas removed 4.3 (5.04) 4.84 (4.58) 3 (1–21) 4 (1–21) Myoma weight, g 23.7 (191.15) 270.16 (197.24) 170.5 (54–814) 254 (14–972) Hospital stay, d 0.97 (0.42) 0.42 (0.626) 1 (0.5–2.0) 0 (0–2) a

Values are given as mean (SD) and median (range).

After Quill Suture (n 5 107)

p Value

1 (3.23)

0

.23

0 2 (6.45) 0 0

2 (1.887) 4 (3.74) 1 (0.93) 1 (0.93)

.60 .41 .78 .78

Values are given as No. (%).

.001

Values are given as mean (SD) and median (range).

Variable

a

Before Quill Suture (n 5 31)

p Value .01 .54 .66 .52 .001

incidence of complications of laparoscopic myomectomy, a larger prospective cohort study will be required to examine the incidence of complications, if any, across the 2 groups under scrutiny. Laparoscopic myomectomy is a safe option for treatment of uterine myomas [8], and seems to be associated with decreased postoperative morbidity as compared with myomectomy via laparotomy [9]. However, suturing of the myometrial defect can be technically challenging for gynecologic surgeons, and this may have limited widespread adoption of this minimally invasive procedure. In our experience, use of this suture material can greatly facilitate closure of the myometrial defect, even in experienced hands. This may enable more gynecologic surgeons to perform minimally invasive myomectomy. A limitation of our study is the retrospective nature of the analysis and the comparison of 2 periods for the same surgeon. It is possible that the surgical experience of the surgeon increased during the duration of the study, which could potentially affect the results, as evidenced by a ‘‘practiceeffect.’’ However, the primary surgeon had extensive experience in performing laparoscopic myomectomy before implementation of barbed suture; therefore, significant improvement in surgical technique is unlikely. In addition, the consecutive case series of hysterotomy closure with barbed suture included the first cases in which this suture material was used, thereby incorporating the component of a learning curve with use of barbed suture. Furthermore, inclusion of all procedures performed by a single surgeon gives the advantage of minimizing operator variability, thus eliminating potential intervention bias that could have influenced the results. Disease in our series was fairly advanced, with multiple large myomas removed on average. The advantage of barbed suture may not be so apparent in simpler cases involving a solitary small myoma in which suturing may not be so challenging and time-intensive. Owing to the retrospective nature of the study and the inclusion of successive laparoscopic myomectomy procedures, in tune with our inclusion criteria, lack of randomization is a limitation of the present study. However, the 2 cohorts under study were fairly similar, and the critical difference between the 2 operative techniques was solely the use of bidirectional barbed suture. This limits the influence of unforeseen confounding factors that could have influenced the results and lends credibility to the significantly shorter operating time with the use of bidirectional

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Barbed Suture for Laparoscopic Myomectomy

barbed suture. Moreover, the results have been consistent in the original analysis of the consecutive series of 107 laparoscopic myomectomy procedures using the bidirectional barbed suture and in the subgroup analysis based on equal treatment-specific sample sizes (n 5 31) devoid of any confounding practice-effect. Furthermore, a recent randomized clinical trial comparing hysterotomy closure time using unidirectional barbed suture vs traditional suture found a significantly shorter hysterotomy closure time with unidirectional barbed suture, which is consistent with our findings [10]. In conclusion, use of bidirectional barbed suture for hysterotomy closure significantly shortens total operating time during laparoscopic myomectomy and, in our experience, greatly facilitates laparoscopic closure of the hysterotomy site. References 1. Available at: http://www.accessdata.fda.gov/cdrh_docs/pdf4/k042075. pdf. 2004. Accessed July 2010. 2. Leung JC. Barbed suture technology: recent advances. Medical Textiles: Proceedings of the 149th International Conference and Exhibition. Pittsburgh, PA: October 26-27; 62–80.

95 3. Rashid RM, Sartori M, White LE, Villa MT, Yoo SS, Alam M. Breaking strength of barbed polypropylene sutures: rater-blinded, controlled comparison with nonbarbed sutures of various calibers. Arch Dermatol. 2007;143:869–872. 4. Rodeheaver GT, Pineros-Fernandez A, et al. Barbed sutures for wound closure: in vivo wound security, tissue compatibility and cosmesis measurements. Society for Biomaterials 30th Annual Meeting Transactions. 2004;229:232. 5. Greenberg JA, Einarsson JI. The use of bidirectional barbed suture in laparoscopic myomectomy and total laparoscopic hysterectomy. J Minim Invasive Gynecol. 2008;15:621–623. 6. Moran ME, Marsh C, Perrotti M. Bidirectional-barbed sutured knotless running anastomosis v classic Van Velthoven suturing in a model system. J Endourol. 2007;21:1175–1178. 7. Frishman G. Vasopressin: if some is good, is more better? Obstet Gynecol. 2009;113:476–477. 8. Malzoni M, Sizzi O, Rossetti A, Imperato F. Laparoscopic myomectomy: a report of 982 procedures. Surg Technol Int. 2006;15:123–129. 9. Cicinelli E, Tinelli R, Colafiglio G, Saliani N. Laparoscopy vs minilaparotomy in women with symptomatic uterine myomas: a prospective randomized study. J Minim Invasive Gynecol. 2009;16:422–426. 10. Alessandri F, Remorgida V, Venturini PL, Ferrero S. Unidirectional barbed suture versus continuous suture with intracorporeal knots in laparoscopic myomectomy: a randomized Study [published online ahead of print July 31, 2010]. J Minim Invasive Gynecol. 2010;17:725–729.