Elizabeth Rose Mueller1, Kimberly Kenton2, Jennifer T Anger3, Catherine Bresee4, Christopher Tarnay5. 1. Departments of Obstetrics/Gynecology and Urology, Loyola University Chicago Stritch School of Medicine, Maywood, Illinois. Electronic address: emuelle@lumc.edu. 2. Departments of Obstetrics/Gynecology and Urology, Northwestern University Feinberg School of Medicine, Chicago, Illinois. 3. Division of Urology, Department of Surgery, Cedars-Sinai Medical Center, Los Angeles, California. 4. Biostatistics and Bioinformatics Research Center, Cedars-Sinai Medical Center, Los Angeles, California. 5. Department of Obstetrics/Gynecology, David Geffen School of Medicine, University of California, Los Angeles, Los Angeles, California.
Abstract
STUDY OBJECTIVE: To prospectively measure trocar site appearances 1 year after surgery in women participants in the Abdominal Colpopexy: Comparison of Endoscopic Surgical Strategies Trial, a 2-center randomized surgical trial (NCT01124916). DESIGN: Supplementary analysis of a surgical trial that randomized women to robotic or laparoscopic sacrocolpopexy (Canadian Task Force classification I). SETTING: Operative trial. PATIENTS: Women undergoing clinically indicated sacrocolpopexy for symptomatic stage≥II pelvic organ prolapse were randomized to laparoscopic abdominal sacrocolpopexy (LASC) or robotic abdominal sacrocolpopexy (RASC). Trocar skin incision closure was standardized by using Dermabond (Ethicon, Somerville, NJ). MEASUREMENTS AND MAIN RESULTS: Photographs of all incision sites were taken at baseline (immediately), 6 weeks, 6 months, and 1 year after surgery. Study coordinators scored each incision with the validated Stony Brook Evaluation Scale (SBES), a 5-point wound evaluation scale. We calculated the average of all scars scores per case to determine the percent of optimal wound healing (0%-100%) for each case as well as the proportion of cases meeting 100% wound repair scoring. Wound repair scores across groups were tested with the Wilcoxon rank sum test. The overall proportion of cases in each group meeting "optimal" wound recovery (scores of 100%) was tested with the Fisher exact test. Seventy-eight women with a mean age of 59 years (range, 26-79 years) were randomized to LASC (n = 38) or RASC (n = 40). We did not detect significant differences in baseline characteristics or rates of dropout between the 2 study groups (5 in LASC and 7 in RASC, p = .60). Pain in the initial postoperative period was higher in the robotic arm although groups were similar at 2 weeks. Nearly all cases (75/78) contributed wound repair data (36 laparoscopic and 39 robotic). Laparoscopic surgeries require significantly fewer incisions (median = 4; range, 4-6) than robotic surgeries (median = 5; range, 4-6; p < .001). SBES scores at 6 weeks were not different for LASC and RASC (p = .426). By 6 months, the scores were better in the LASC group (84.8% ± 8.8% vs 78.5% ± 7.2%, p = .031), and this finding remained at 1 year (93.4% ± 7.2% vs 85.9% ± 8.8%, p = .001). The proportion of cases with optimal wound repair (score of 100%) was higher in the laparoscopic arm at 1 year after surgery (12/27 vs 4/33, p = .008). INTERVENTIONS: Women were randomized to robotic assisted laparoscopy or laparoscopy. CONCLUSION: Wound appearance using the SBES was better in the LASC group, suggesting that there may be alterations in the mechanism for wound initiation and/or healing based on the minimally invasive route used for sacrocolpopexy.
RCT Entities:
STUDY OBJECTIVE: To prospectively measure trocar site appearances 1 year after surgery in womenparticipants in the Abdominal Colpopexy: Comparison of Endoscopic Surgical Strategies Trial, a 2-center randomized surgical trial (NCT01124916). DESIGN: Supplementary analysis of a surgical trial that randomized women to robotic or laparoscopic sacrocolpopexy (Canadian Task Force classification I). SETTING: Operative trial. PATIENTS: Women undergoing clinically indicated sacrocolpopexy for symptomatic stage ≥II pelvic organ prolapse were randomized to laparoscopic abdominal sacrocolpopexy (LASC) or robotic abdominal sacrocolpopexy (RASC). Trocar skin incision closure was standardized by using Dermabond (Ethicon, Somerville, NJ). MEASUREMENTS AND MAIN RESULTS: Photographs of all incision sites were taken at baseline (immediately), 6 weeks, 6 months, and 1 year after surgery. Study coordinators scored each incision with the validated Stony Brook Evaluation Scale (SBES), a 5-point wound evaluation scale. We calculated the average of all scars scores per case to determine the percent of optimal wound healing (0%-100%) for each case as well as the proportion of cases meeting 100% wound repair scoring. Wound repair scores across groups were tested with the Wilcoxon rank sum test. The overall proportion of cases in each group meeting "optimal" wound recovery (scores of 100%) was tested with the Fisher exact test. Seventy-eight women with a mean age of 59 years (range, 26-79 years) were randomized to LASC (n = 38) or RASC (n = 40). We did not detect significant differences in baseline characteristics or rates of dropout between the 2 study groups (5 in LASC and 7 in RASC, p = .60). Pain in the initial postoperative period was higher in the robotic arm although groups were similar at 2 weeks. Nearly all cases (75/78) contributed wound repair data (36 laparoscopic and 39 robotic). Laparoscopic surgeries require significantly fewer incisions (median = 4; range, 4-6) than robotic surgeries (median = 5; range, 4-6; p < .001). SBES scores at 6 weeks were not different for LASC and RASC (p = .426). By 6 months, the scores were better in the LASC group (84.8% ± 8.8% vs 78.5% ± 7.2%, p = .031), and this finding remained at 1 year (93.4% ± 7.2% vs 85.9% ± 8.8%, p = .001). The proportion of cases with optimal wound repair (score of 100%) was higher in the laparoscopic arm at 1 year after surgery (12/27 vs 4/33, p = .008). INTERVENTIONS:Women were randomized to robotic assisted laparoscopy or laparoscopy. CONCLUSION: Wound appearance using the SBES was better in the LASC group, suggesting that there may be alterations in the mechanism for wound initiation and/or healing based on the minimally invasive route used for sacrocolpopexy.
Authors: E R Mueller; K Kenton; C Tarnay; L Brubaker; A Rosenman; B Smith; K Stroupe; C Bresee; A Pantuck; P Schulam; J T Anger Journal: Contemp Clin Trials Date: 2012-05-27 Impact factor: 2.226
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Authors: Marie Fidela R Paraiso; J Eric Jelovsek; Anna Frick; Chi Chung Grace Chen; Matthew D Barber Journal: Obstet Gynecol Date: 2011-11 Impact factor: 7.661
Authors: Jennifer T Anger; Elizabeth R Mueller; Christopher Tarnay; Bridget Smith; Kevin Stroupe; Amy Rosenman; Linda Brubaker; Catherine Bresee; Kimberly Kenton Journal: Obstet Gynecol Date: 2014-01 Impact factor: 7.661
Authors: R M Freeman; K Pantazis; A Thomson; J Frappell; L Bombieri; P Moran; M Slack; P Scott; M Waterfield Journal: Int Urogynecol J Date: 2012-08-03 Impact factor: 2.894