UNLABELLED: Study Type - RCT (randomized trial) Level of Evidence 2b. What's known on the subject? and What does the study add? In a previous randomized controlled trial, barbed polyglyconate suture for vesico-urethral anastomosis was associated with more frequent cystogram leaks, longer mean catheterization times and greater suture costs per case. In the current randomized controlled trial, we show that barbed polyglyconate suture is associated with decreased anastomosis time, decreased need to readjust suture tension, cost reduction, and equal continence and early/late urinary complication rates. OBJECTIVE: To examine the effectiveness of barbed polyglyconate suture (V-Loc 180; Covidien, Mansfield, MA, USA) compared with standard monofilament for posterior reconstruction (PR) and vesico-urethral anastomosis (VUA) during robot-assisted radical prostatectomy (RARP). PATIENTS AND METHODS: A prospective randomized controlled trial was conducted in 70 consecutive RARP cases by a single surgeon (K.C.Z.). Standard VUA was performed using three 4-0 poliglecaprone 25 (Monocryl; Ethicon Endosurgery, Cincinnati, OH, USA) sutures secured with absorbable suture clips (LapraTy, Ethicon; one single 6-inch [15.2 cm] for PR and two attached 6-inch [15.2 cm] for VUA). Barbed suture VUA was performed using two 3-0 6-inch (15.2 cm) barbed polyglyconate sutures. Time to complete the suture set-up by the nursing team, anastomosis time and need to adjust suture tension were recorded. Suture-related complications, validated-questionnaire continence and cost were also examined. RESULTS: Compared with a conventional reconstruction technique, there was a significant reduction in mean nurse set-up time (31 vs. 294 s; P < 0.01) and reconstruction time (13.1 vs. 20.8 min; P < 0.01) for the barbed suture technique. Need to readjust suture tension or to place additional suture clips for watertight closure was greater in the standard monofilament group than in the barbed suture group (6% vs. 24%; P= 0.03). • A cost reduction was recorded at our institution (48.05 vs. 70.25 $CAN) with the barbed suture technique. • With a mean follow-up of 6.2 months, no delayed anastomotic leak or bladder neck contracture was observed in either group. • Pad-free continence outcomes for the monofilament suture vs the barbed suture groups at 1 (64 vs. 69%, P= 0.6), 3 (76 vs. 81%, P= 0.5) and 6 months (88 vs. 92%, P= 0.7) were similar. CONCLUSIONS: • Compared with standard monofilament suture, the unidirectional barbed polyglyconate suture appears to provide safe, efficient and cost-effective PR and VUA during RARP. • Use of the interlocked barbed polyglyconate suture technique prevents slippage, precluding the need for assistance, knot-tying and constant reassessment of anastomosis integrity.
RCT Entities:
UNLABELLED: Study Type - RCT (randomized trial) Level of Evidence 2b. What's known on the subject? and What does the study add? In a previous randomized controlled trial, barbed polyglyconate suture for vesico-urethral anastomosis was associated with more frequent cystogram leaks, longer mean catheterization times and greater suture costs per case. In the current randomized controlled trial, we show that barbed polyglyconate suture is associated with decreased anastomosis time, decreased need to readjust suture tension, cost reduction, and equal continence and early/late urinary complication rates. OBJECTIVE: To examine the effectiveness of barbed polyglyconate suture (V-Loc 180; Covidien, Mansfield, MA, USA) compared with standard monofilament for posterior reconstruction (PR) and vesico-urethral anastomosis (VUA) during robot-assisted radical prostatectomy (RARP). PATIENTS AND METHODS: A prospective randomized controlled trial was conducted in 70 consecutive RARP cases by a single surgeon (K.C.Z.). Standard VUA was performed using three 4-0 poliglecaprone 25 (Monocryl; Ethicon Endosurgery, Cincinnati, OH, USA) sutures secured with absorbable suture clips (LapraTy, Ethicon; one single 6-inch [15.2 cm] for PR and two attached 6-inch [15.2 cm] for VUA). Barbed suture VUA was performed using two 3-0 6-inch (15.2 cm) barbed polyglyconate sutures. Time to complete the suture set-up by the nursing team, anastomosis time and need to adjust suture tension were recorded. Suture-related complications, validated-questionnaire continence and cost were also examined. RESULTS: Compared with a conventional reconstruction technique, there was a significant reduction in mean nurse set-up time (31 vs. 294 s; P < 0.01) and reconstruction time (13.1 vs. 20.8 min; P < 0.01) for the barbed suture technique. Need to readjust suture tension or to place additional suture clips for watertight closure was greater in the standard monofilament group than in the barbed suture group (6% vs. 24%; P= 0.03). • A cost reduction was recorded at our institution (48.05 vs. 70.25 $CAN) with the barbed suture technique. • With a mean follow-up of 6.2 months, no delayed anastomotic leak or bladder neck contracture was observed in either group. • Pad-free continence outcomes for the monofilament suture vs the barbed suture groups at 1 (64 vs. 69%, P= 0.6), 3 (76 vs. 81%, P= 0.5) and 6 months (88 vs. 92%, P= 0.7) were similar. CONCLUSIONS: • Compared with standard monofilament suture, the unidirectional barbed polyglyconate suture appears to provide safe, efficient and cost-effective PR and VUA during RARP. • Use of the interlocked barbed polyglyconate suture technique prevents slippage, precluding the need for assistance, knot-tying and constant reassessment of anastomosis integrity.
Authors: Vito De Blasi; Olivier Facy; Martine Goergen; Virginie Poulain; Luigi De Magistris; Juan Santiago Azagra Journal: Obes Surg Date: 2013-01 Impact factor: 4.129
Authors: Khanh N Pham; Bryan S Sack; R Corey O'Connor; Michael L Guralnick; Peter Langenstroer; William A See; Kenneth Jacobsohn Journal: Can Urol Assoc J Date: 2013 Nov-Dec Impact factor: 1.862