The Use of Barbed Suture for Bladder and Bowel Repair

The Use of Barbed Suture for Bladder and Bowel Repair

Original Article The Use of Barbed Suture for Bladder and Bowel Repair Dina Chamsy, MD*, Cara King, DO, and Ted Lee, MD From the Division of Minimall...

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Original Article

The Use of Barbed Suture for Bladder and Bowel Repair Dina Chamsy, MD*, Cara King, DO, and Ted Lee, MD From the Division of Minimally Invasive Gynecologic Surgery, Department of Obstetrics, Gynecology and Reproductive Sciences, University of Pittsburgh Medical Center, Pittsburgh, PA (all authors).

ABSTRACT Study Objective: To describe the laparoscopic repair of bladder and bowel injuries using barbed suture and review postoperative outcomes. Design: Retrospective medical chart review (Canadian Task Force classification II-3). Setting: Large academic medical institution. Patients: Thirty-three women who underwent laparoscopic repair of the bladder and/or bowel wall using barbed suture between January 2009 and July 2013. Intervention: Not applicable. Measurement and Main Results: The patients underwent a total of 9 cystotomies (27.3%), 7 enterotomies (21.2%), 4 bladder seromuscular injuries (12.1%), 12 bowel seromuscular injuries (36.4%), and 1 bladder and bowel seromuscular injury (3.0%). Of the 33 injuries, 17 (51.5%) were intentional in the setting of bladder or bowel endometriosis nodule excision, whereas the other 16 (48.5%) were accidental and occurred at the time of lysis of adhesions. Thirteen of 14 bladder injuries (92.9%) were at the dome, and 1 injury (7.1%) was at the trigone. Fifteen of 20 bowel injuries (75%) were rectal, 3 (15%) were on the colon, and 2 (10%) were on the small intestine. Cystotomies ranged in length from 1 to 5 cm, and enterotomies ranged from 1.5 to 6 cm. All bladder and bowel seromuscular injuries were repaired using a single layer of barbed suture. Twelve fullthickness bladder or bowel wall defects (75%) were repaired using 2 layers of barbed suture, and 4 defects (25%) were repaired using a layer of barbed suture and a layer of a running or interrupted smooth delayed absorbable suture. Duration of follow-up ranged from 1 month to 15 months. There were no major complications. Only 1 patient who had undergone a large enterotomy repair developed constipation secondary to a mild rectal stricture diagnosed 3 months postoperatively. Symptoms of constipation since resolved spontaneously in that patient. Conclusion: Barbed suture provides adequate tension-free bladder and bowel repair. No major complications have been encountered; therefore, the use of barbed suture for the repair of bladder or bowel defects seems feasible and safe. Journal of Minimally Invasive Gynecology (2015) 22, 648–652 Ó 2015 AAGL. All rights reserved. Keywords:

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Barbed suture; Cystotomy repair; Enterotomy repair; Laparoscopy

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The introduction of knotless barbed suture into the surgical market decreased the challenges of laparoscopic suturing Ted Lee serves as a consultant for Ethicon. Cara King and Dina Chamsy report no conflicts of interest. This study was presented as an oral abstract at the American Association of Gynecologic Laparoscopists 43rd Global Congress, November 16–21, 2014 Vancouver, Canada. Corresponding author: Dina Chamsy, MD, Magee-Womens Hospital of UPMC, 300 Halket St, Pittsburgh, PA 15213. E-mail: [email protected] Submitted December 16, 2014. Accepted for publication January 28, 2015. Available at www.sciencedirect.com and www.jmig.org 1553-4650/$ - see front matter Ó 2015 AAGL. All rights reserved. http://dx.doi.org/10.1016/j.jmig.2015.01.030

and intracorporeal knot tying. Although initially approved by the Food and Drug Administration (FDA) for soft tissue approximation, it is now being extensively used and marketed for a variety of laparoscopic surgeries, including urologic and gastrointestinal procedures [1,2]. The first published report on the use of barbed suture in gynecologic surgery was by Greenberg and Einarsson in 2008 [3]. Since then, barbed suture has gained popularity in the field of minimally invasive gynecologic surgery and is now commonly used to close the vaginal cuff in total laparoscopic hysterectomy and to reapproximate the myometrium after laparoscopic myomectomy. Barbed suture also

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Barbed Suture for Bladder and Bowel Repair

is being increasingly used to close the peritoneum following mesh placement in sacrocolpopexy procedures. Gynecologists do not commonly encounter cystotomies or enterotomies in their practice, and thus opinions on the use of barbed suture to repair bladder and bowel injuries are conflicting owing to anecdotal descriptions and lack of solid data. The majority of studies evaluating the efficacy and safety of barbed suture for bladder and bowel repair have been conducted in animals. In an vitro randomized controlled study, Gozen et al [4] demonstrated that running barbed suture for pig bladder closure is faster and more effective than traditional monofilament suture. Demyttenaere et al [5] demonstrated that 3-0 unidirectional barbed suture compared with 3-0 Maxon offers comparable, yet faster closure of pig bowel. Omotosho et al [6] also concluded that barbed suture compares favorably with monofilament suture for gastrotomy and enterotomy closure in dogs. Research conducted on human tissue is scarce. Nemecek et al [7] conducted a study on 20 human cadavers and showed that unidirectional barbed suture has a higher bursting pressure than monofilament suture in small intestinal anastomoses. Another study by Tyner et al [8] compared the use of barbed suture and traditional monofilament suture in the laparoscopic suturing of gastrojejunostomy and jejunojejunostomy in 84 obese patients undergoing gastric bypass surgery. Both groups had similar complication rates at 30 days. Although most of these studies had outcomes favoring the use of barbed suture, the results cannot be generalized, because many of these studies were conducted on animals and had small numbers of subjects. As stated by Greenberg [9] in his review on the use of barbed suture in Obstetrics and Gynecology in 2010, ‘‘the choice and use of suture in obstetrics and gynecology is based more on anecdote and experience than data.’’ Owing to the paucity of solid data supporting the use of barbed suture in bladder and bowel repair, many surgeons still comply with the traditional use of interrupted or running smooth sutures. Because our practice at Magee-Womens Hospital is a referral center for the management of advanced endometriosis, we perform a large number of advanced bladder and bowel endometriosis excisional procedures by conventional laparoscopy, and thus are well experienced with primary bladder and bowel repair. We began using unidirectional barbed suture in bladder and bowel repairs in 2009 based on the limited yet favorable data available on the use of barbed suture for bladder and bowel repair. The objective of this retrospective chart review is to describe cases of both intentional and accidental bladder or bowel injuries that were repaired laparoscopically with barbed suture, and to evaluate postoperative outcomes. Materials and Methods Approval from the University of Pittsburgh’s Institutional Review Board was obtained to search the electronic medical

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records and identify patients who had undergone laparoscopic bladder or bowel repair by a single surgeon (T.L.) between January 2009 and July 2013. Current Procedural Terminology codes for ‘‘cystotomy repair,’’ ‘‘suturing of small bowel lacerations,’’ and ‘‘suturing of large bowel laceration’’ and International Classification of Diseases, Ninth Revision codes for ‘‘endometriosis of unspecifed site,’’ ‘‘intestinal endometriosis,’’ and ‘‘accidental puncture of laceration’’ were used, and a total of 202 charts were reviewed. Inclusion criteria included cystotomy repair, enterotomy repair, and oversewing of bladder or bowel seromuscular injuries using at least 1 layer of delayed absorbable barbed suture. We excluded all cases where smooth monofilament suture was exclusively used to perform the repair. Thirtythree patients met these criteria and were included in the study. A retrospective review of medical records was then conducted to abstract information about these 33 patients. We collected demographic data including age, race, body mass index (BMI), parity, and past surgical history. We also gathered information regarding the patients’ presenting symptoms, primary surgery performed, details regarding the bladder or bowel injury including its cause, location, size, instrument used at the time the injury occurred, type of injury (mechanical vs thermal) and description of the repair including number of layers, sutures used, axis of repair, and placement of corner suspension sutures. Postoperative course was also recorded, including complications and the duration of follow-up. Results are given using descriptive statistics using Stata data analysis and statistical software (StataCorp, College Station, TX). Continuous data are given as mean, standard deviation (SD), and 95% confidence interval when normally distributed and as median and interquartile range (IQR) when not normally distributed. Categorical data are given as frequency and percentage. Results Thirty-three patients were found to have undergone bladder and/or bowel repair using barbed suture by a single surgeon at our institution between January 2009 and July 2013. Mean patient age was 40.6 (10.6) years, and mean BMI was 26.8 (5.8). Twenty-nine patients (87.9%) were white, and 4 patients (12.1%) were African American. Thirteen (39.4%) were nulliparous, and 20 (60.6%) were multiparous. Three patients (9.1%) had not undergone previous surgery, 10 (30.3%) had undergone a previous laparoscopic procedure, 11 (33.3%) had undergone a previous laparotomy, and 9 (27.3%) had undergone previous laparoscopic and open procedures. Twenty-nine patients (87.9%) presented with pelvic pain, 11 (33.3%) had abnormal uterine bleeding, and 4 (12.1%) had pelvic organ prolapse (Table 1). The primary surgical procedures were 12 total laparoscopic hysterectomies (36.5%), 13 laparoscopic excisions of endometriosis (39.4%), 3 salpingoophorectomies

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Table 1 Patient characteristics Variable

Value

Age, yr, mean (SD), 95% CI Race, n (%) White African American BMI, mean (SD), 95% CI Parity, n (%) Nulliparous Multiparous Surgical history, n (%) Negative Previous laparoscopy Previous laparotomy Previous laparoscopy and laparotomy Presenting symptoms, n (%) Pain Bleeding Prolapse

40.6 (10.6), 37.0–44.2 29 (87.9) 4 (12.1) 26.8 (5.8), 24.8–28.7 13 (39.4) 20 (60.6) 3 (9.1) 10 (30.3) 11 (33.3) 9 (27.3)

29 (87.9) 11 (33.3) 4 (12.1)

(9.1%), 3 sacrocolopexies (9.1%), and 2 trachelectomies (6.1%). Bladder and bowel injuries included 9 cystotomies (27.2%), 7 enterotomies (21.2%), 4 bladder seromuscular injuries (12.1%), 12 bowel seromuscular injuries (39.4%), and 1 bladder and bowel seromuscular injury (3.0%). Although 16 of the bladder or bowel injuries were accidental Table 2 Surgical details Variable Primary surgical procedure Total laparoscopic hysterectomy Laparoscopic excision of endometriosis Laparoscopic salpingo-ophorectomy Trachelectomy Injury Cystotomy Enterotomy Bladder seromuscular injury Bowel seromuscular injury Bladder and bowel seromuscular injury Cause of injury Accidental (lysis of adhesions) Planned (excision of endometriosis) Planned (excision of ectopic adenomyoma) Seromuscular repair One layer of barbed suture Cystotomy and enterotomy repair Two layers of barbed suture One layer of smooth delayed absorbable suture and 1 layer of barbed suture

Patients, n (%) 12 (36.5) 13 (39.4) 3 (9.1) 2 (6.1) 9 (27.2) 7 (21.2) 4 (12.1) 12 (39.4) 1 (3.0) 16 (48.5) 16 (48.5) 1 (3.0)

16 (100) 12 (75) 4 (25)

(48.5%) and occurred at the time of lysis of adhesions, 17 (51.5%) were intentional and had to be performed to excise bladder or bowel endometriosis nodules in 16 patients and to remove an ectopic adenomyoma that developed from previous morcellation in 1 patient (Table 2). Thirteen of 14 bladder injuries were at the dome (92.9%), and 1 injury was at the bladder trigone (7.1%). Fifteen of 20 bowel injuries were on the rectum (75%), 3 were on the colon (15%), and 2 were on the small intestine (10%). Cystotomies ranged in size from 1 to 5 cm, and enterotomies ranged from 1.5 to 6 cm. The surgical instrument used and the type of injury (thermal vs mechanical) were not always specified in the operative report. The 35-mm Enseal (Ethicon Endo-Surgery, Cincinnati, OH) was used in 11 bladder injuries and 8 bowel injuries. In the majority of these cases, the Enseal device was intentionally used to create a cystotomy or enterotomy to facilitate enucleation of deep infiltrating bladder or bowel endometriotic nodules. Endo Shears scissors (Covidien, Mansfield, MA) were used in 5 bowel injuries. The instruments used in the remaining 8 procedures were undocumented. The surgeon reported the injury as thermal in 1 case of bladder cystotomy and mechanical in 4 cases of bowel injury. In the remaining procedures, the nature of the injury was undocumented. All bladder or bowel seromuscular injuries were repaired using a single layer of 3-0 barbed suture. Twelve (75%) fullthickness bladder or bowel wall defects were repaired using 2 layers of 3-0 barbed suture, and 4 (25%) were repaired using a layer of barbed suture and a layer of a running or interrupted smooth delayed absorbable suture (Table 2). The V-Loc 90 unidirectional absorbable suture (Covidien) was used in 32 of 33 cases, and the Quill bidirectional barbed suture (Angiotech Pharmaceutical, Vancouver, BC, Canada) was used to repair 1 cystotomy. The axis of repair was not consistently mentioned in the operative reports; suturing along the transverse axis was performed in 2 cystotomy, 5 enterotomy, and 2 bowel seromuscular repairs. Suturing along the longitudinal axis was performed in 4 bowel seromuscular repairs. Corner stitches were placed in 3 cystotomies and 5 enterotomies using delayed absorbable sutures that were tied extracorporeally to help align the anterior and posterior edge of the defect to facilitate the suturing process. During the repair of the largest enterotomy in our series, an interrupted suture was placed in the mid-portion of the bowel defect to ensure tissue apposition. Following all enterotomy repairs, a bubble test was performed intraoperatively using a proctoscope to confirm an air-tight seal. Patients who underwent cystotomy repair were discharged home with a Foley catheter for 10 days, followed by a voiding cystourethrogram that confirmed a watertight repair. The median follow-up period was 4 months (range, 1– 15 months). All patients were evaluated in the office during postoperative week 4, and all were without complaints. One patient who had undergone a 6-cm enterotomy repair

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Barbed Suture for Bladder and Bowel Repair

following excision of deep rectal endometriosis developed constipation. A mild rectal stricture was diagnosed 3 months postoperatively by barium enema. Constipation improved with conservative management and subsequently resolved. During the duration of follow-up, 6 patients underwent reoperation for reasons not associated with the primary surgery, and none experienced complications. Discussion In our series, we encountered no major complications related to the use of barbed suture in the repair of bladder and bowel walls. We believe that this is related to the suture properties that make it ideal for bladder and bowel repairs, as well as to the use of proper surgical technique. Barbed suture offers several advantages over traditional monofilament suture. Primarily, barbs allow the suture to self-anchor to tissue, thereby decreasing the risk of suture slippage and eliminating the need for a third hand assistant to follow the thread during the suturing process. The lack of knots makes the suturing process less time-consuming and more efficient for the surgeon. Furthermore, the circumferential distribution of equally spaced barbs improves consistent wound apposition and equal distribution of tissue tension across the suture line, thereby providing a more secure wound closure. Moreover, because knots constitute the weakest point of any suture line, the lack of knots in barbed suture decreases the risk of suture breakage. In fact, both in vivo and in vitro studies have demonstrated that barbed suture has superior tensile strength and tissue-holding capacity [4], helping it withstand potential disruptive forces on the suture line from bladder or bowel wall distention [9]. As a synthetic monofilament suture, barbed suture causes minimal tissue abrasion and local inflammatory tissue reaction. This makes it suitable for bowel and bladder repairs, which are prone to bacterial contamination and infection. Many physicians fear the risk of suture barbs cutting through the bladder or bowel walls; however, this is rarely an issue if suture and tissue are handled appropriately. Barbed suture should always be pulled and tightened in the direction of the needle pass without excessive force to form a watertight seal without inflicting tissue damage. Correct surgical technique is a key component to the lack of complications when repairing bladder or bowel wall defects [10]. We typically perform cystotomy and enterotomy repairs in 2 layers, with either both layers of 3-0 barbed suture or a layer of smooth monofilament suture and a layer of barbed suture. The first layer is sutured in a continuous fashion and incorporates the full thickness of the bladder or bowel wall including the serosa, muscularis, and mucosa. The second layer consists of a continuous imbricating suture that incorporates the bladder or bowel serosa and a portion of the muscularis. When repairing cystotomies, the parietal peritoneum overlying the bladder is incorporated in the second layer. The purpose of the second layer is to reinforce the closure and take tension off the first layer. Any tissue tension

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felt during the suturing process should be addressed. Dissection of the prevesicular space is a technique for increasing tissue laxity across the bladder suture line. When suturing cystotomies in proximity to the ureteral orifices, inserting a 5-Fr ureteral catheter is crucial to identify the course of the ureters and avoid inadvertent kinking. Cystoscopy is routinely performed after cystotomy closure, to ensure proper mucosal coaptation and water tight closure. When repairing small bowel, repairing the enterotomy in a transverse fashion, perpendicular to the longitudinal axis of the bowel, is commonly recommended to prevent narrowing of the bowel lumen. In contrast, the rectosigmoid colon has a large lumen, and thus as long as a rectal probe can pass through the site of the enterotomy repair without meeting any resistance, the risk of bowel obstruction and stricture formation is minimized. Therefore, when repairing large bowel enterotomies, the orientation of the suture line should be selected based on the axis that approximates tissue with the least amount of tension without compromising the caliber of the bowel lumen. Once the enterotomy is repaired, we typically perform a bubble test using a proctoscope to confirm an airtight seal. Our minimally invasive approach to repairing bladder and bowel using barbed suture yielded good outcomes in our series of 33 patients. The lack of complications in our series is related to our proper understanding of the barbed suture properties and the use of proper surgical technique. The case of mild rectal stricture was likely related to the large enterotomy size rather than to the specific use of barbed suture for the repair. In the setting of large bladder or bowel wall defects, ensuring proper wound apposition is challenging. The larger the distance to be sutured, the more likely that tissue edges may be misaligned. This in turn increases the risks of leakage from the repair site and stricture formation. One useful approach is to tag the corners of the defect with 2 interrupted smooth delayed absorbable sutures. The purpose of these 2 sutures is to tent up the corners of the cystotomy or enterotomy and help align the anterior and posterior edges of the defect to facilitate the closure. A third delayed absorbable interrupted suture can be applied at mid-position to divide the cystotomy or enterotomy into 2 halves. Each half is then repaired separately, thereby decreasing the risk of uneven mucosal coaptation. Based on our experience, when the bowel defect encompasses .50% of the bowel circumference, it may be advisable to perform a bowel resection with end-to-end anastomosis rather than a primary enterotomy repair, to avoid the risks of leakage, stricture formation, and dehiscence. Although we have not encountered any complications pertaining to the use of this new type of suture material, complications have been reported in the literature, including case reports of bowel obstruction and volvulus [11–15]. Therefore, as this suture material becomes more commonly used in cystotomy and enterotomy closure, the incidence and prevalence of suture complications may increase. Studies describing the costs of barbed suture in minimally invasive gynecologic surgery are lacking.

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However, studies in other surgical specialties report costsaving benefits. Smith et al [16] stated that although barbed suture is more expensive than smooth monofilament suture, its use in arthroplasties is economical owing to a significant decrease in operating room time. Zorn et al [17] also reported an overall decrease in cost of prostatectomies because the use of barbed suture eliminates the need to use additional costly products, such as the absorbable suture clips, to secure the suture. Thus, we can extrapolate that the use of barbed suture in complex surgeries such as laparoscopic bladder and bowel repair may have cost-saving benefits. Our study is limited by the small sample size, summarizing data from only 33 patients. The fact that only 16 patients (49.5%) had full thickness bowel or bladder injuries further decreased the sample size when it came to assessing cystotomy and enterotomy repairs with barbed suture. Moreover, the fact that all of the procedures were conducted by a single highly skilled minimally invasive surgeon makes the results less generalizable. Complications potentially could be greater in the hands of surgeons not trained to perform advanced laparoscopic procedures. Other limitations include missing data from the operative report, such as information on the type of surgical instrument used at the time of bladder or bowel injury and whether the injury was purely mechanical or thermal. Although only 1 injury was reported as thermal, we believe that the majority of injuries were mechanical in nature. Even though a bipolar instrument (Enseal) was commonly used by the surgeon in our series, this instrument is oftentimes used to dissect and cut tissue with minimal activation of energy, especially when operating in proximity to bladder or bowel walls, to minimize thermal damage. Finally, although the duration of postoperative follow up did not exceed 15 months, we do not believe that this decreases the quality of our study, given that we would expect serious bladder and bowel complications to manifest in the acute postoperative phase rather than remote from surgery. In conclusion, unidirectional barbed suture has properties that make it ideal for bladder and bowel wall repair. Based on our experience at Magee-Womens Hospital, the use of barbed suture in bladder and bowel repair seems to be safe and effective. However, complications may arise as use of this suture becomes more widespread in the near future. Therefore, additional research comparing barbed suture and smooth monofilament suture in the setting of bladder and bowel repair is needed before formal recommendations can be made.

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References 1. Shah HN, Nayyar R, Rajamahanty S, et al. Prospective evaluation of unidirectional barbed suture for various indications in surgeoncontrolled robotic reconstructive urologic surgery: Wake Forest University experience. Int Urol Nephrol. 2012;44:775–785. 2. Covidien. Wound closure: barbed sutures. Available at: http://surgical. covidien.com/products/wound-closure/barbed-sutures#resources. Accessed October 23, 2014. 3. Greenburg JA, Einarsson JI. The use of bidirectional barbed suture in laparoscopic myomectomy and total laparoscopic hysterectomy. J Minim Invasive Gynecol. 2008;5:621–623. 4. G€ozen AS, Arslan M, Schulze M, et al. Comparison of laparoscopic closure of the bladderwith barbed polyglyconate versus polyglactin suture material in the pig bladder model: an experimental in vitro study. J Endourol. 2012;26:732–736. 5. Demyttenaere SV, Nau P, Henn M, et al. Barbed suture for gastrointestinal closure: a randomized control trial. Surg Innov. 2009;16:237–242. 6. Omotosho P, Yurcisin B, Ceppa E, et al. In vivo assessment of an absorbable and nonabsorbable knotless barbed suture for laparoscopic single-layer enterotomy closure: a clinical and biomechanical comparison against nonbarbed suture. J Laparoendosc Adv Surg Tech A. 2011; 21:893–897. 7. Nemecek E, Negrin L, Beran C, et al. The application of the V-LOC closure device for gastrointestinal sutures: a preliminary study. Surg Endosc. 2013;27:3830–3834. 8. Tyner RP, Clifton GT, Fenton SJ. Handsewn gastrojejunostomy using knotless unidirectional barbed absorbable suture during laparoscopic gastric bypass. Surg Endosc. 2013;27:1360–1366. 9. Greenberg JA. The use of barbed sutures in obstetrics and gynecology. Rev Obstet Gynecol. 2010;3:82–91. 10. Chamsy D, Lee T. The use of barbed suture in bladder and bowel surgery. Surg Technol Int. 2013;23:153–159. 11. Donnellan NM, Mansuria SM. Small bowel obstruction resulting from laparoscopic vaginal cuff closure with a barbed suture. J Minim Invasive Gynecol. 2011;18:528–530. 12. Buchs NC, Ostermann S, Hauser J, et al. Intestinal obstruction following use of laparoscopic barbed suture: a new complication with new material? Minim Invasive Ther Allied Technol. 2012;21:369–371. 13. Burchett MA, Mattar SG, McKenna DT. Iatrogenic intestinal and mesenteric injuries with small bowel volvulus following use of barbed suture during laparoscopic myomectomy. J Laparoendosc Adv Surg Tech A. 2013;23:632–634. 14. Quibel S, Roman H, Marpeau L. Volvulus following barbed suture. Gynecol Obstet Fertil. 2012;40:382–383. 15. Thubert T, Pourcher G, Deffieux X. Small bowel volvulus following peritoneal closure using absorbable knotless device during laparoscopic sacral colpopexy. Int Urogynecol J. 2011;22:761–763. 16. Smith EL, DiSegna ST, Shukla PY, Matzkin EG. Barbed versus traditional sutures: closure time, cost, and wound related outcomes in total joint arthroplasty. J Arthroplasty. 2014;29:283–287. 17. Zorn KC, Trinh QD, Jeldres C, et al. Prospective randomized trial of barbed polyglyconate suture to facilitate vesico-urethral anastomosis during robot-assisted radical prostatectomy: time reduction and cost benefit. BJU Int. 2012;109:1526–1532.