Prospective study of an ultra-lightweight polypropylene Y mesh for robotic sacrocolpopexy

Abstract Introduction and hypothesis To prospectively evaluate the use of a particular polypropylene Y mesh for robotic sacrocolpopexy. Methods This was a prospective study of 120 patients who underwent robotic sacrocolpopexy. We compared preoperative and 12-month postoperative objective and subjective assessments via the Pelvic Organ Prolapse Quantification (POP-Q), the Pelvic Floor Distress Inventory, Short Form 20 (PFDI-20); the Pelvic Floor Impact Questionnaire, Short Form 7 (PFIQ-7); and the Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire 12 (PISQ-12). Objective "anatomical success" was defined as POP-Q stage 0 or 1 at all postoperative intervals. We further defined "clinical cure" by simultaneously considering POP-Q points and subjective measures. To be considered a "clinical cure," a given patient had to have all POP-Q points ≤0, apical POP-Q point C ≤5, no reported pelvic organ prolapse symptoms on the PFDI-20, and no reoperation for prolapse at all postoperative intervals. Results Of the 120 patients, 118 patients completed the 1-year follow-up. The objective "anatomical success" rate was 89 % and the "clinical cure" rate was 94 %. The PFDI-20 mean score improved from 100.4 at baseline to 21.0 at 12 months (p<0.0001); PFIQ-7 scores improved from 61.6 to 8.0 (p<0.0001); and PISQ-12 scores improved from 35.7 to 38.6 (p <0.0009). No mesh erosions or mesh-related complications occurred. Conclusion The use of this ultra-lightweight Y mesh for sacrocolpopexy, eliminated the mesh-related complications in the first postoperative year, and provided significant improvement in subjective and objective outcomes

Subjective and Objective Results 1 Year after Robotic Sacrocolpopexy using a Lightweight Y-Mesh

Introduction and hypothesis: The objective of this study was to assess outcomes following robotic sacrocolpopexy using a lightweight polypropylene Y-mesh. Methods: During our study period, all patients who underwent robotic sacrocolpopexy were enrolled in this single-arm prospective trial. Endpoints included Pelvic Organ Prolapse Quantification (POP-Q) values; Pelvic Floor Distress Inventory, short form 20 (PFDI-20); Pelvic Floor Impact Questionnaire, short form 7 (PFIQ-7); Surgical Satisfaction scores; and the Sandvik Incontinence Severity Index. All surgeries were performed with a pre-configured monofilament type 1 polypropylene Y-mesh (Alyte©, C.R. Bard, Covington, GA, USA). Cure rates at 12 months were calculated using two separate definitions: (1) \u27clinical cure\u27: no POP-Q points \u3e 0, point C ≤ −5, no prolapse symptoms on the PFDI-20, and no reoperations for prolapse and (2) \u27objective anatomic cure\u27: POP-Q stage 0 or 1, point C of ≤ −5, and no reoperations for prolapse. Results: A total of 150 patients underwent robotic sacrocolpopexy and 143 (95 %) were available for 12-month follow-up. Mean age was 58.6 ± 9.8 and mean body mass index was 26.3 ± 4.5. Mean operative time and blood loss were 148 ± 27.6 min (range 75-250 min) and 51.2 ± 32, respectively. There were no mesh erosions or exposures, and mesh edges were not palpable in any patient. At 12 months the clinical cure rate was 95 %, and the objective anatomic cure rate was 84 %. The PFDI-20 mean score improved from 98 at baseline to 17 at 12 months ( p \u3c 0.0001); PFIQ-7 scores improved from 59 to 6.5 ( p \u3c 0.0001). Conclusions: Robotic sacrocolpopexy using this lightweight polypropylene Y-mesh offers excellent subjective and objective results at 1 year. [ABSTRACT FROM AUTHOR

Prospective Cohort Study of Bowel Function After Robotic Sacrocolpopexy

Objective: This study aimed to determine bowel function changes 12 months after robotic sacrocolpopexy. Methods: We performed a single-center prospective cohort study evaluating bowel function 12 months after robotic sacrocolpopexy between 2007 and 2011. Bowel function symptoms were measured by the Colorectal-Anal Distress Inventory, Short Form 8 (CRADI-8). Specific impacts on quality of life with regard to bowel function were evaluated using the Colorectal-Anal Impact Questionnaire, Short Form 7 (CRAIQ-7). Splinting to defecate was defined as any positive response to question 4 of the Pelvic Floor Distress Inventory-20 which reads, do you ever have to push on the vagina or around the rectum to have or complete a bowel movement?. Lastly, patients were grouped according to perineorrhaphy versus no perineorrhaphy and bowel function scores were examined. Results: Of 423 consecutive patients who underwent robotic sacrocolpopexy at our institution, 393 (93%) completed a 12-month follow-up. Mean CRADI-8 scores at baseline and 12 months were 21.1 (20) and 7.3 (11), respectively (P \u3c 0.0001). Mean CRAIQ-7 scores at baseline and 12 months were 11.1 (20) and 2.4 (9), respectively (P \u3c 0.0001). Preoperatively, 152 patients reported a need to splint the vagina or perineum to complete a bowel movement. At 12 months, 70% reported complete resolution of splinting. Con comitant perineorrhaphy was performed on 87 patients and there were no differences in 12-month CRADI-8 or CRAIQ-7 scores between groups. Conclusions: Robotic sacrocolpopexy was associated with significant improvements in bowel function as measured by CRADI-8 as well as improvements in impact on quality of life as measured by CRAIQ-7

Prospective Study of an Ultra-lightweight Polypropylene Y Mesh for Robotic Sacrocolpopexy

Introduction and hypothesis: To prospectively evaluate the use of a particular polypropylene Y mesh for robotic sacrocolpopexy. Methods: This was a prospective study of 120 patients who underwent robotic sacrocolpopexy. We compared preoperative and 12-month postoperative objective and subjective assessments via the Pelvic Organ Prolapse Quantification (POP-Q), the Pelvic Floor Distress Inventory, Short Form 20 (PFDI-20); the Pelvic Floor Impact Questionnaire, Short Form 7 (PFIQ-7); and the Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire 12 (PISQ-12). Objective \u27anatomical success\u27 was defined as POP-Q stage 0 or 1 at all postoperative intervals. We further defined \u27clinical cure\u27 by simultaneously considering POP-Q points and subjective measures. To be considered a \u27clinical cure,\u27 a given patient had to have all POP-Q points ≤0, apical POP-Q point C ≤5, no reported pelvic organ prolapse symptoms on the PFDI-20, and no reoperation for prolapse at all postoperative intervals. Results: Of the 120 patients, 118 patients completed the 1-year follow-up. The objective \u27anatomical success\u27 rate was 89 % and the \u27clinical cure\u27 rate was 94 %. The PFDI-20 mean score improved from 100.4 at baseline to 21.0 at 12 months ( p \u3c 0.0001); PFIQ-7 scores improved from 61.6 to 8.0 ( p \u3c 0.0001); and PISQ-12 scores improved from 35.7 to 38.6 ( p \u3c 0.0009). No mesh erosions or mesh-related complications occurred. Conclusion: The use of this ultra-lightweight Y mesh for sacrocolpopexy, eliminated the mesh-related complications in the first postoperative year, and provided significant improvement in subjective and objective outcomes

Predictive Validity of a Training Protocol Using a Robotic Surgery Simulator

Background: Robotic surgery simulation may provide a way for surgeons to acquire specific robotic surgical skills without practicing on live patients. Methods: Five robotic surgery experts performed 10 simulator skills to the best of their ability, and thus, established expert benchmarks for all parameters of these skills. A group of credentialed gynecologic surgeons naive to robotics practiced the simulator skills until they were able to perform each one as well as our experts. Within a week of doing so, they completed robotic pig laboratory training, after which they performed supracervical hysterectomies as their first-ever live human robotic surgery. Time, blood loss, and blinded assessments of surgical skill were compared among the experts, novices, and a group of control surgeons who had robotic privileges but no simulator exposure. Sample size estimates called for 11 robotic novices to achieve 90% power to detect a 1 SD difference between operative times of experts and novices ([alpha] = 0.05). Results: Fourteen novice surgeons completed the study-spending an average of 20 hours (range, 9.7-38.2 hours) in the simulation laboratory to pass the expert protocol. The mean operative times for the expert and novices were 20.2 (2.3) and 21.7 (3.3) minutes, respectively (P = 0.12; 95% confidence interval, -1.7 to 4.7), whereas the mean time for control surgeons was 30.9 (0.6) minutes (P \u3c 0.0001; 95% confidence interval, 6.3-12.3). Comparisons of estimated blood loss (EBL) and blinded video assessment of skill yielded similar differences between groups. Conclusions: Completing this protocol of robotic simulator skills translated to expert-level surgical times during live human surgery. As such, we have established predictive validity of this protocol