Cosmetic Appearance of Port-site Scars 1 Year After Laparoscopic Versus Robotic Sacrocolpopexy: A Supplementary Study of the ACCESS Clinical Trial

Abstract

STUDY OBJECTIVE To prospectively measured trocar site appearances 1-year following surgery in women participants in the Abdominal Colpopexy: Comparison of Endoscopic Surgical Strategies (ACCESS) Trial, a 2-center randomized surgical trial (NCT01124916). DESIGN Supplementary analysis of a surgical trial that randomized women to a robotic or laparoscopic sacrocolpopexy DESIGN CLASSIFICATION I. Evidence pulled from a properly designed, randomized controlled trial SETTING Operative trial PATIENTS Women undergoing a clinically indicated sacrocolpopexy for symptomatic stage ≥ II POP and were randomized to a laparoscopic (LASC) or robotic (RASC) technique. Trocar skin incision closure was standardized by using Dermabond. MEASUREMENTS 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 to 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’s exact test. RESULTS 78 women with a mean age of 59 years (range 26–79) were randomized: LASC (n=38) and RASC (n=40). We did not detect significant differences in baseline characteristics or rates of drop-out between the two study groups (5 in LASC and 7 in RASC, p=0.60). Pain in the initial post-operative period was higher in the robotic arm, although groups were similar at two weeks. Nearly all cases (75/78) contributed wound repair data (36 laparoscopic, 39 robotic). Laparoscopic surgeries require significantly fewer incisions (median 4, range 4 to 6) than robotic surgeries (median 5, range 4 to 6; p<0.001). SBES scores at 6 weeks were not different for LASC and RASC (p=0.426). By 6 months the scores were better in the LASC group (84.8+/−8.8% vs. 78.5+/−7.2%, p =0.031) and this finding remained at one year (93.4+/−7.2% vs. 85.9+/−8.8%, p=0.001). The proportion of cases with optimal wound repair (score of 100%) was higher in the laparoscopic arm at one year (12/27 vs 4/33 p=0.008) one year after surgery. 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.

Surgical Updates in the Treatment of Pelvic Organ Prolapse

“…This was confirmed by a multicenter randomized trial of laparoscopic versus robotic sacrocolpopexy performed by Anger et al, which also found increased hospital costs, longer operating room times, and higher pain scores in the robotic arm, without any differences in symptom bother, POP stage at 6 months, or adverse events 57. A planned ancillary study of the Anger trial comparing the wound healing of laparoscopic versus robotic port site incisions showed an improved cosmetic appearance from laparoscopic incisions over robotic 58. However, laparoscopic skills are known to require a steeper, more difficult, learning curve and skilled assistants.…”

“… 57 A planned ancillary study of the Anger trial comparing the wound healing of laparoscopic versus robotic port site incisions showed an improved cosmetic appearance from laparoscopic incisions over robotic. 58 However, laparoscopic skills are known to require a steeper, more difficult, learning curve and skilled assistants. For this reason, robotic sacrocolpopexy has been adopted by many surgeons who wish to offer minimally invasive repairs with a faster and easier learning curve and improved optics.…”

Research quality and transparency, outcome measurement and evidence for safety and effectiveness in robot-assisted surgery: systematic review

“…Using only the most recent time point of ‘long‐term follow‐up’ of primary outcomes for a given study population yielded 103 principal studies 14–116 for detailed analysis ( Table S1 , supporting information). There were 99 two‐arm studies (96·1 per cent) and four three‐arm studies (3·9 per cent), with a median of 78 (range 6–1516) patients.…”

The surgical ‘Robot’ in gynaecology: It isn’t a robot at all, and it doesn’t make anything better

“…Furthermore, the post‐operative appearance of the incisions appears to be compromised. A randomised trial comparing laparoscopic sacrocolpexy with and without microprocessor support demonstrated objective evidence of prolonged healing for women randomised to da Vinci‐assisted laparoscopic surgery, fully a year after the procedure, with cosmetic‐based incision scores significantly lower than those for women with the standard technique …”