Laparoscopy and Robotics Anastomosis During Robot-assisted Radical Prostatectomy: Randomized Controlled Trial Comparing Barbed and Standard Monofilament Suture Jesse Sammon, Tae-Kyung Kim, Quoc-Dien Trinh, Akshay Bhandari, Sanjeev Kaul, Shyam Sukumar, Craig G. Rogers, and James O. Peabody OBJECTIVE
To compare perioperative and functional outcomes after urethrovesical anastomosis (UVA) with barbed polyglyconate and monofilament poliglecaprone in robot-assisted radical prostatectomy (RARP). Barbed polyglyconate suture was first used for the UVA during RARP beginning in January 2010; safety and feasibility were previously demonstrated in 51 patients. From May to September 2010, 64 patients meeting all the inclusion criteria participated in the present multisurgeon prospective, randomized, controlled trial and underwent posterior repair and UVA during RARP with either barbed polyglyconate (n ⫽ 33) or monofilament poliglecaprone (n ⫽ 31) suture. The primary outcomes were the anastomotic (UVA) and posterior reconstruction times. Secondary outcomes included cystogram leak, bladder neck reconstruction rate, and 6-week functional outcomes assessed by a self-administered validated patient questionnaire. Posterior reconstruction was performed within 3.3 minutes with the barbed suture versus 4.3 minutes with the monofilament poliglecaprone suture (23.3% reduction) and UVA within 10.1 versus 13.8 minutes, respectively (26.8% reduction). The absolute time difference for the 2-layer anastomosis was 4.7 minutes (a 26.0% reduction in the total anastomosis time). All other perioperative outcomes were equivalent between the 2 groups. Urinary functional outcomes, including the pad use and leakage rates, were equivalent at 6 weeks. Anastomosis during RARP with the V-Loc barbed suture can be performed safely and more efficiently than with standard monofilament suture. We demonstrated a 26% decrease in the anastomotic time with no increase in the adverse events, no instances of urinary retention and equivalent functional outcomes were measured with the self-administered patient questionnaire. UROLOGY 78: 572–580, 2011. © 2011 Elsevier Inc.
obot-assisted radical prostatectomy (RARP) was first performed in the United States in 2001.1,2 The technique of urethrovesical anastomosis (UVA) during RARP has evolved since the early reports described a single-layer, interrupted anastomosis, modeled after open retropubic radical prostatectomy.2,3 Two widely adopted modifications have been the running Van Velthoven UVA4 and reconstruction of the posterior rhabdosphincter, described by Rocco et al.5,6 We previously described the first experience using barbed polyglyconate suture (V-Loc, Covidien, Mansfield, MA), incorporating it into our 2-layer UVA during RARP. Beginning in January 2010, we demonstrated the
From the Vattikuti Urology Institute, Henry Ford Hospital, Detroit, Michigan Reprint requests: Jesse Sammon, D.O., Vattikuti Urology Institute, Henry Ford Hospital, 2799 West Grand Boulevard, Detroit, MI 48202. E-mail: [email protected]
Submitted: December 26, 2010, accepted (with revisions): March 26, 2011
© 2011 Elsevier Inc. All Rights Reserved
feasibility and safety in 51 patients.7 UVA with the barbed suture was found to be efficient, the unidirectional barbs prevented slippage, precluding the need for assistance or knot tying. The use of barbed suture has become common practice at our institution and ⬎600 cases have been performed with it within the 12 months following first use. We performed the present prospective randomized controlled trial to compare the efficiency and safety of UVA with V-Loc versus monofilament poliglecaparone (Monocryl, Ethicon, Sommerville, NJ).
MATERIAL AND METHODS Patients This was a 2-group, parallel, randomized clinical trial (RCT) performed from May to September 2010, in accordance with a study protocol approved by the institutional review board of Henry Ford Hospital. Data collection and follow-up were performed in accordance with the Health Insurance Portability 0090-4295/11/$36.00 doi:10.1016/j.urology.2011.03.069
Figure 1. Consort flow diagram of participant’s passage through study.
and Accountability Act of 1996. All consecutive patients undergoing RARP by 1 of 2 experienced robotic surgeons (J.O.P., C.G.R.) were considered for inclusion in the present study. Both surgeons had extensive experience with the barbed suture before conducting the present study and had begun using it in reconstructive prostate and kidney applications. The exclusion criteria were as follows: (a) prostate weight ⬎100 g on preoperative transrectal ultrasonography (because urinary function was a secondary outcome and a large prostate size has been associated with a delayed return to continence at our institution); (b) previous radiotherapy; and (c) participation in an alternate RCT.
Sample Size Calculation The sample size was calculated according to the findings from a preliminary feasibility study performed at our institution and comparison with data from historic controls. We anticipated a 25% reduction in anastomotic time7; with a power of 0.90 and ␣ of 0.05, the sample size was determined to be 64 patients (32 in each arm).
Surgical Technique Transperitoneal RARP with a 3-armed Da Vinci robot (Intuitive, Sunnyvale, CA), using the Vattikuti Institute prostatectomy technique, as described by Menon et al,8,9 including recent modifications, has been previously described. In brief, the surgical steps were as follows: (a) development of the extraperitoneal space (retropubic space of Retzius); (b) lymph node dissection; (c) bladder neck transection; (d) nerve sparing; (e) exposure of the prostatic apex and control of the dorsal venous complex; (f) UVA; and (g) bladder drainage, preferentially with a percutaneous suprapubic catheter. Our technique using the barbed suture for the UVA was recently described and was standardized for all cases.7 The periurethral tissue (posterior rhadbosphincter) and Denonvilliers’ fascia were reapproximated using a single 6-in., barbed, 3-0 UROLOGY 78 (3), 2011
polyglyconate suture (V-Loc, Covidien, Mansfield, MA) on a 17-mm RB-1 needle (Fig. 2A). For the UVA, a bidirectional barbed suture with 2 needles was prepared from two 6-in. 3-0 sutures by passing the needle of each suture through the looped end effecter of the other (Fig. 2B). The UVA was then performed, starting at the 5-o’clock position and directed outside-in on the posterior bladder wall. The first arm of the suture was run for 3 bites in the bladder neck and 2 in the urethra before the 2 structures were approximated. The bulk of the loop end effecters prevented the pulling through of the suture for the first throw, just as the knots of the conventional Van Velthoven4 stitch prevent pull through. The anastomosis was continued in a clockwise fashion until the 11-o’clock position was reached. The barbs prevent slippage of the suture and obviate the need to readjust throws or have an assistant maintain traction. The other arm of the suture was run counterclockwise from the 5-o’clock position to the 11-o’clock position. Because of the sutures ability to prevent slippage, no knot was tied at the conclusion of the anastomosis in the barbed suture group. A new 20F Foley catheter was then introduced, and the bladder was instilled with 240 mL of normal saline. Watertight closure of the anastomosis was verified, and a 14F percutaneous suprapubic catheter was placed.9,10 If significant hematuria is present or if a large bladder neck reconstruction was performed, the Foley catheter is used for bladder drainage. The UVA and posterior reconstruction (PR) in the control arm of the study were performed identically, with the exception of the suture material used (monofilament poliglecaparone, Monocryl, Ethicon, Sommerville, NJ), the tying of knots at the conclusion of the PR, and the use of assistants to maintain tension on the running anastomosis. Bladder neck reconstruction, when required, was performed at the conclusion of the anastomosis at the anterior urethrovesical junction. Although no longer routine practice at our institution, cystography was performed 6-8 days postoperatively to evaluate for contrast extravasation and was followed by catheter re573
measured included the perioperative and patient-specific outcomes (Table 1). The 2-sided Student t test and Wilcoxon rank sum tests were used to compare continuous variables. Fisher’s exact test and Pearson’s chi-square test were used to compare categorical variables. P ⬍ .05 was considered statistically significant. All statistical analyses were performed using SAS, version 9.2 (SAS Institute, Cary, NC).
Figure 2. (A) Important suture characteristics, including laser etched barbs, 2-cm barb-free zone immediately trailing needle and looped end effecter. (B) Two 6 –in. 3-0 V-Loc sutures made bidirectional by passing needle of each suture through opposing suture’s looped end effecter. moval. If bladder neck reconstruction was performed, the catheter was removed by postoperative day 9-14.
Randomization Randomization to the V-Loc or Monocryl anastomosis was performed after transection of the prostate-urethral junction to eliminate bias in the performance of the bladder neck and urethral dissection. The “⫽RAND()” function of Excel (Microsoft, Redmond, WA) was used to produce a random 6-digit number ⱖ0 and ⬍1. The subjects assigned a number ending in 0 or an even number were assigned to the barbed suture group and those assigned an odd number to the control group.
Outcome Measures Data were collected prospectively. The primary outcome measure was anastomotic time, with PR and UVA times measured separately. Secondary outcome measures included cystogram leak, bladder neck reconstruction rate, and the 6-week functional outcomes assessed with a modified Expanded Prostate Cancer Index Composite (EPIC) questionnaire, given to the patient at his 6-week visit and mailed back to the home institution.11 A modification was made to the EPIC questionnaire for the purpose of the present study: the patients were asked about symptoms within the past week only. The other outcomes 574
From May to August 2010, 109 patients undergoing RARP by 2 surgeons at the Vattikuti Urology Institute were assessed for inclusion in the present RCT. Figure 1 demonstrates the flow of patients through the present study. Of the 107 patients, 5 refused to participate, 4 had received previous radiotherapy, 2 had an ultrasoundestimated prostate mass ⬎100 g, and 32 had participated in an alternative RCT. The remaining 64 were assigned to and received anastomosis with Monocryl (n ⫽ 31) or V-Loc (n ⫽ 33) suture. Of these 64 patients, 4 were excluded from the analysis of functional outcomes but were included in the assessment of the perioperative outcomes because of a prostate mass ⬎100 g on the final pathologic examination (the transrectal ultrasound measurements were not available at the time of surgery); additionally 1 patient was lost to follow-up after catheter removal. Baseline patient characteristics, which did not differ between the two groups, are listed in Table 1. Although the median American Urologic Association symptom score was higher in the study group, it was not significantly so. Study outcomes are listed in Table 2. The anastomosis was performed more efficiently in the barbed suture arm, with PR performed within 3.3 minutes versus 4.3 minutes (23.3% reduction) and UVA within 10.1 versus 13.8 minutes (26.8% reduction). The absolute time difference for the 2-layer anastomosis was 4.7 minutes. All other perioperative characteristics were statistically equivalent between the Monocryl arm and the study arm, including bladder neck reconstruction (3 vs 5), catheter duration (7.6 vs 6.8 days), and the incidence of cystogram leak at 1 week (a single grade 1 vs 0).12 Three patients experienced immediate complications (within 6 weeks of RARP), 2 in the Monocryl arm and 1 in the barbed suture arm. The most significant was seen in 1 patient in the control arm who presented to the emergency room with clot retention, which was treated with Foley catheter irrigation. This patient had undergone bladder neck reconstruction after removal of his 102-g prostate (the transrectal ultrasound measurements were unavailable preoperatively), and experienced the only cystogram leak in the present study. The cystogram leak was treated with prolonged Foley catheterization (13 days). A single patient in the barbed suture arm experienced a wound infection, which was treated with antibiotics, and a patient in the control arm experienced selflimiting leg pain. No patient in either study arm had experienced bladder neck contracture at a median folUROLOGY 78 (3), 2011
Table 1. Comparison of baseline patient characteristics and perioperative parameters by study arm Characteristic Age (y) Median IQR PSA (ng/mL) Median IQR BMI (kg/m2) Median IQR AUA-SS Median IQR AUA bother score Median IQR Biopsy Gleason score 6 7 ⱖ8 Previous abdominal surgery Active smoking Alcohol use Operative time (min) Median IQR Console time (min) Median IQR Estimated blood loss (mL) Median IQR Nerve sparing performed Bilateral intrafascial* Unilateral intrafascial* Standard Wide excision Intraoperative anastomotic leak Bladder neck reconstruction Posterior layer reconstruction (min) Urethrovesical anastomosis (min) Postoperative cystogram leak Catheterization duration (min) Median IQR Mean ⫾ SD Hospital stay (d) Median IQR Complications† Pathologic stage pT2 pT3 Surgical Gleason score 6 7 ⱖ8 Prostatic mass (g) Median IQR
Monofilament (n ⫽ 31)
V-Loc (n ⫽ 33)
P Value .069
60 52.5-66 .528
.809 .333 7 3-11
.645 .965 14 (45.2) 14 (45.2) 3 (9.7) 11 (35.5) 5 (16.1) 6 (19.4)
14 (42.4) 16 (48.5) 3 (9.1) 15 (45.5) 5 (15.2) 13 (39.4)
8 (19.4) 5 (16.1) 19 (61.3) 1 (3.2) 2 (6.45) 3 (9.7) 4.3 ⫾ 0.2 13.8 ⫾ 0.7 1 (3.2)
2 (6.1) 7 (21.2) 21 (63.6) 3 (9.1) 0 (0) 5 (15.15) 3.3 ⫾ 0.2 10.1 ⫾ 0.7 0 (0)
7 6-8 7.6 ⫾ 0.3
7 6-7 6.8 ⫾ 0.3
.417 .909 .080 .973 .793 .306 .338
1 1-1 2 (6.5)
1 1-1 1 (3.0)
18 (58.1) 13 (41.9)
20 (60.6) 13 (39.4)
3 (9.7) 24 (77.4) 4 (12.9)
7 (21.2) 24 (72.7) 2 (6.1)
.138 .508 ⬍.001 ⬍.001 .298 .284 — .096 .302 .518 .836 .332
.127 49 39-64
IQR, interquartile range; PSA, prostate-specific antigen; BMI, body mass index; AUA-SS, American Urological Association Symptom Score. Data presented as numbers, with percentages in parentheses, unless otherwise noted. * Alternatively described as veil of Aphrodite, high anterior release, curtain dissection. † By 6 weeks.
UROLOGY 78 (3), 2011
Table 2. Comparison by suture type of functional outcomes 6 weeks after robot-assisted radical prostatectomy Functional Outcome Measures Follow-up for functional outcomes (d) Median IQR During the past week, how often have you leaked urine? More than once a day About once a day More than once a week About once a week Rarely or never During past week, how often have you urinated blood? More than once a day About once a day More than once a week About once a week Rarely or never During past week, how often have you had pain or burning with urination? More than once a day About once a day More than once a week About once a week Rarely or never Which of the following best describes your urinary control during the past week? No urinary control whatsoever Frequent dribbling Occasional dribbling Total control How many pads or adult diapers daily did you usually use to control leakage during the past week? None 1 full pad/d 2 pads/d ⱖ3 pads/d How big a problem, if any, has each of the following been for you during the past week? Dripping or leaking urine No problem Very small problem Small problem Moderate problem Big problem Pain or burning on urination: No problem Very small problem Small problem Moderate problem Big problem Bleeding with urination: No problem Very small problem Small problem Moderate problem Big problem Weak urine stream or incomplete emptying: No problem
Monofilament (n ⫽ 28)
V-Loc (n ⫽ 31)
P Value .268 .279
14 (50) 9 (32.1) 1 (3.6) 2 (7.1) 2 (7.1)
17 (54.8) 6 (19.4) 2 (6.5) 0 (0) 6 (19.4) .6151
— — 1 (3.60) — 27 (96.4)
— — 2 (6.5) — 29 (93.5) .666
2 (7.1) 2 (7.1) — 2 (7.1) 22 (78.6)
1 (3.2) 1 (3.2) — 1 (3.2) 28 (90.3) .139
0 (0) 7 (25) 19 (67.9) 2 (7.1)
2 (6.5) 3 (9.7) 20 (64.5) 6 (19.4) .826
14 (50) 6 (21.4) 5 (17.9) 3 (10.7)
16 (51.6) 9 (29) 4 (12.9) 2 (6.5)
7 (25) 6 (21.4) 8 (28.6) 6 (21.4) 1 (3.6)
12 (38.7) 9 (29) 4 (12.9) 4 (12.9) 2 (6.5)
19 (67.9) 7 (25) 1 (3.6) 0 (0) 1 (3.6)
27 (87.1) 3 (9.7) 0 (0) 1 (3.2) 0 (0)
26 (92.9) 2 (7.1) 0 (0) 0 (0) 0 (0)
29 (93.5) 2 (6.5) 0 (0) 0 (0) 0 (0)
.665 20 (71.4)
20 (64.5) Continued
UROLOGY 78 (3), 2011
Table 2. Continued Functional Outcome Measures Very small problem Small problem Moderate problem Big problem Waking up to urinate No problem Very small problem Small problem Moderate problem Big problem Need to urinate frequently during the day No problem Very small problem Small problem Moderate problem Big problem Overall, how big a problem has your urinary function been for you during the past week? No problem Very small problem Small problem Moderate problem Big problem Overall, how satisfied are you with the treatment you received for your prostate cancer? Extremely dissatisfied Dissatisfied Uncertain Satisfied Extremely satisfied AUA-SS Median IQR AUA-SS change Median IQR
Monofilament (n ⫽ 28)
V-Loc (n ⫽ 31)
5 (17.9) 3 (10.7) 0 (0) 0 (0)
7 (22.6) 2 (6.5) 1 (3.2) 1 (3.2)
15 (53.6) 6 (21.4) 2 (7.1) 3 (10.7) 2 (7.1)
16 (51.6) 8 (25.8) 4 (12.9) 3 (9.7) 0 (0)
.955 15 (53.6) 4 (14.3) 4 (14.3) 4 (14.3) 1 (3.6)
15 (48.4) 4 (12.9) 7 (22.6) 4 (12.9) 1 (3.2) .575
9 (32.1) 6 (21.4) 8 (28.6) 4 (14.3) 1 (3.6)
14 (45.2) 9 (29) 5 (16.1) 2 (6.5) 1 (3.2) .826
0 (0) 0 (0) 2 (7.1) 4 (14.3) 22 (78.6)
0 (0) 0 (0) 3 (9.7) 3 (9.7) 25 (80.6)
Abbreviations as in Table 1. Data presented as numbers, with percentages in parentheses, unless otherwise noted.
low-up of 9.1 months. The urinary function outcomes (secondary study outcomes) ascertained using the modified EPIC questionnaire given at 6 weeks are listed in Table 2. The treatment arms were equivalent in pad use and bother, but the barbed suture arm had a greater 6-week American Urological Association Symptom Score (8 vs 5.5; P ⫽ .040). Although a significant difference was found between the 2 groups at 6 weeks, no statistically or clinically significant change was found in the American Urological Association Symptom Score in either arm relative to their preoperative level.13
COMMENT Since the adoption of the running, bidirectional monofilament anastomosis to UVA in 2003,4 several modifications have been introduced to overcome the limitations of the closure relating to suture slippage. Ball et al14 described using a Lapra-Ty to hold the posterior approxUROLOGY 78 (3), 2011
imation tight. Berry et al15 described using 3 posterior interrupted sutures for the same purpose. The drawbacks of these techniques include the reliance on assistants, foreign bodies adjacent to the UVA, and sutures tied within the bladder neck. The barbed suture leads to increased efficiency because of its resistance to slippage, obviating the need for assistance, reliance on knots, or other fastening devices. Another widespread modification to the running UVA, largely in pursuit of improved early continence, is the reapproximation of Denonvilliers’ fascia and the posterior periurethral tissue (rhabdosphincter), often described as posterior reconstruction (PR) or the “Rocco stitch.” Originally conceptualized for use during retropubic radical prostatectomy by Klein16 in 1992 and popularized by Rocco et al.6 This technique, or a variant of periprostatic reconstruction, has been adapted to the laparoscopic and robotic environment at numerous insti577
tutions with varied effects on early continence.5,17-21 A prospective RCT by Menon et al19 failed to demonstrate the benefit to early continence with PR as a part of complete perianastomotic reconstruction. Similarly, Joshi et al18 reported, in a prospective alternate assignment, parallel-group study, no improvement in the continence rates (no leakage or pad use) between the groups at 3 (25% vs 31%; P ⫽ .391) and 6 months (49% vs 57%; P ⫽ .686) after RARP. Nevertheless, the preponderance of studies using historical controls as a comparative group have noted improved early continence with PR.5,17,20,21 The case for PR in UVA was made cogently by Stein22 and is currently the standard of care at our institution, despite our own negative RCT findings. Although the lack of uniformity in technique makes direct comparisons between any of these studies impossible, a general consensus has been reached about PR, including that it makes the UVA easier. The approximation of Denonvilliers’ fascia and the posterior urethral rhabdosphincter bring the bladder neck and urethral stump into close proximity, facilitating the delicate anastomosis. This unquantifiable increase in ease, coupled with a decreased cystographic leak rate, seen in 2 studies,17,19 and no perceived risk has induced us to continue use of the PR and incorporate it into the techniques assessed in the present study. Our initial feasibility study demonstrated that, without modification in the technique, the barbed suture could be safely and efficiently incorporated into our UVA with a 2-layer anastomotic time of 14.6 minutes (interquartile range 12-22), without adverse events.23 Tewari et al24 demonstrated similar findings when incorporating barbed suture use. They noted a reduction in anastomosis time from 13.5 to 8 minutes (P ⬍ .001). This 40% gain in efficiency was greater than the 26% seen in the present study but consistent with our findings. Williams et al25 published the first RCT incorporating the use of the barbed suture in their UVA technique, concluding that barbed polyglyconate increased the cost, required technical modifications to avoid overtightening, increased the rate of cystogram leakage, and prolonged the catheterization. Comparisons with the present study, however, should be made with caution. Several differences between our study and that by Williams et al25 are worthy of mention, particularly the difference in technique. Our study describes a technique using barbed suture exclusively in a continuous running UVA, with PR. The technique described by Williams et al25 incorporated 3 interrupted polyglactin sutures (Vicryl, Ethicon, Summerville, NJ) along the posterior aspect of the UVA, with running barbed sutures along the lateral and anterior anastomosis, without PR. They experienced significant overtightening in the first 29 barbed suture cases, which they hypothesized led to their high (27.6%) rate of day 9 cystogram leaks. After modifications to the technique were made, this rate decreased to 6.3% (1 of 16). This modification of technique tempers 578
the effect of their findings as a 2-group randomized trial, because it, in effect, produced 2 experimental arms and 1 control arm. The need for technique modification might have been in large part due to the issues of a learning curve, because the investigators had just incorporated the barbed suture into their technique at the outset of their RCT. We had performed ⬎100 anastomoses with the V-Loc barbed suture at our institution, before the initiation of the present study, making the learning curve less of a concern. That said, cystogram leakage was never increased compared with our historical experience, perhaps owing to differences in the technique described. Weld et al26 performed an in vivo porcine study comparing barbed 0 polydioxanone suture (Quill SRS PDO, Angiotech, Vancouver, CA) and 2-0 polyglactin (Vicryl, Ethicon) in the bladder neck anastomosis. They noted significantly greater lamina propria fibrosis and perianastomotic fat fibrosis but no differences in muscle fibrosis or granulation tissue. The potential effect of barbs or suture composition on the inflammatory response is unclear, but only 2 bladder neck contractures developed at our institution in patients undergoing anastomosis with the V-Loc barbed suture in the first 12 months of use (none were seen in the V-Loc arm of the present study). With ⬎600 total anastomoses performed, this rate is at least equivalent to that for anastomoses with Monocryl. The principle limitations of the present study were the selection of the primary outcome and the sample size. The argument will surely be made that a 25% reduction in anastomotic time is a clinically insignificant outcome, particularly for the experienced robotic surgeon. When we compared the results from our preliminary study with those of the historic controls, however, this was the only outcome measure that was significantly different. Moreover, in a surgeon’s early experience, a 25% reduction in anastomotic time might be more significant. Although this was a study of experienced robotic surgeons and it cannot be assumed that the gains in efficiency will be linear across all experience levels (some surgeons could expect greater efficiency gains, some less), we suspect that a novice surgeon can benefit most from the V-Loc suture’s resistance to slippage. Cost is also a perceived limitation, as discussed by Williams et al.25 The suture costs for a 2-layer anastomosis with the V-Loc suture are $70.95 (3 ⫻ $23.65), and the suture costs for the Monocryl anastomosis are $28.50 (3 ⫻ $9.50). We believe this increase in cost will be offset by the gain in efficiency and ease of performing the anastomosis we have seen.
CONCLUSIONS Anastomosis with V-Loc barbed suture can be performed safely and more efficiently than standard monofilament anastomosis. We demonstrated a 25% decrease in the anastomotic time with no increase in adverse events, no instances of urinary retention, and equivalent functional UROLOGY 78 (3), 2011
outcomes, as measured by the patient-administered questionnaire. 20.
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tients undergoing computer assisted (robotic) prostatectomy: results of a 2 group parallel randomized controlled trial. J Urol. 2008;180:1018-1023. Nguyen MM, Kamoi K, Stein RJ, et al. Early continence outcomes of posterior musculofascial plate reconstruction during robotic and laparoscopic prostatectomy. BJU Int. 2008;101:1135-1139. Tewari A, Jhaveri J, Rao S, et al. Total reconstruction of the vesico-urethral junction. BJU Int. 2008;101:871-877. Stein RJ. The case for posterior musculofascial plate reconstruction in robotic prostatectomy. Urology. 2009;74:489-491. Kaul S, Sammon J, Bhandari A, et al. A novel method of urethrovesical anastomosis during robot-assisted radical prostatectomy using a unidirectional barbed wound closure device: feasibility study and early outcomes in 51 patients. J Endourol. 2010;24:17891793. Tewari AK, Srivastava A, Sooriakumaran P, et al. Use of a novel absorbable barbed plastic surgical suture enables a “self-cinching” technique of vesicourethral anastomosis during robot-assisted prostatectomy and improves anastomotic times. J Endourol. 2010;24: 1645-1650. Williams SB, Alemozaffar M, Lei Y, et al. Randomized controlled trial of barbed polyglyconate versus polyglactin suture for robotassisted laparoscopic prostatectomy anastomosis: technique and outcomes. Eur Urol. 2010;58:875-881. Weld KJ, Ames CD, Hruby G, et al. Evaluation of a novel knotless self-anchoring suture material for urinary tract reconstruction. Urology. 2006;67:1133-1137.
EDITORIAL COMMENT Randomized controlled trials (RCTs) demonstrating strong evidence for surgical interventions are rare within urology. The authors of this report are to be congratulated on seeking to provide the best level of evidence for a new technology very early in its introduction.1 Recent urologic interest for the use of barbed sutures has been intense, predominantly for urethrovesical anastomosis (UVA) during robotic radical prostatectomy and during rennorhaphy within robotic partial nephrectomy. This is illustrated by the large number of abstracts on the subject at this year’s major urologic meetings. Interestingly, a similar, recent published RCT by Williams et al2 on the use of the barbed suture for the UVA was negative, showing an increased cystogram leak rate and resulting in prolonged catheterization times, as well as increased costs in the barbed suture arm. The high leak rate of 20% in the first 29 cases decreased substantially after a technical modification to reduce overtightening to 6% (1 incident) for the subsequent 16 cases. It can be inferred from this that this study included patients during the initial learning curve with this suture. Because the technique itself during the study period, it is not a commonly used UVA method, and the learning period seems to have been included, we would view these results carefully. The current report shows a 27% (4.7-minute) reduction in time to perform the UVA in the barbed suture group. More significantly, no increase occurred in the incidence of postoperative complications (including leakage at the UVA on the cystogram at catheter removal). The authors conclude that the barbed suture made the UVA more efficient and that this might have a positive effect positively by reducing the operative times.3 This group had performed ⱖ100 cases with the barbed suture before beginning this RCT, and all were highly experienced robotic surgeons; thus, major learning curve effects were minimal. Both RCTs on this subject demonstrate interesting and valid points. Care must be taken when extrapolating these results to 579