Comparison of the learning curves of a suturing device & standard Laparoscopy

Steven Leeds, MD², Lizzy Wooley, BBA, EMT¹, Ganesh Sankaranarayanan, PhD¹, James Fleshman, MD, FACS, FACRS², Sanket Chauhan, MD¹. ²Baylor University Medical Center, ¹Center for Evidence Based Simulation, Baylor Scott and White Health

Introduction: Endo 360TM (EndoEvolution, LLC; Raynham, MA) is a suturing device aimed to decrease the long learning curve associated with conventional laparoscopic suturing and knot tying. The aim of this study is to compare the learning curves between conventional laparoscopy and Endo360TM .

Materials and Methods: In this prospective single blinded non-randomized controlled crossover study, we recruited 20 general surgery residents ranging from beginner (PGY1-2, n=12) to competent (PGY3-5, n=8). They were assigned to perform laparoscopic knot tying and suturing tasks using either Endo 360 or Laparoscopic needle holders (in no particular order) before crossing over to the other device. The proficiency standards were developed by collecting the data for Task Completion Time (TCT in sec), Dots on Target (DoT in n) and total Deviation (D in mm) on 5 expert attending MIS surgeons (Mean ± 2SD). The test subjects were “proficient” when they reached these standards 2 consecutive times.

The task consisted of applying a standard square knot at one end on a physical model based 5 cm “incision” followed by passing running sutures through pre-marked dots (5 mm apart) on each side of incision. T tests and generalized linear model analysis (GLMA) were performed.

Results: On matched pair t-test of beginner group, significant difference was observed between mean numbers of attempts to reach proficiency for Lap vs Endo360 (p=0.0027). This difference was not statistically significant in competent group. On t-test, there was significant difference for number of attempts to attain proficiency between both Endo 360 (p=0.0126) and Lap (p<0.0001)

The GLMA for TCT demonstrated significantly less time for Endo360 vs Lap task (p<0.0001), beginner vs competent (p=0.0003) and increasing number of trials (p=0.0005). There were significantly less DoT for Endo360 as compared to Laparoscopy (p<0.0001). Similarly, analysis on the D demonstrated a significant deviation in Endo 360 compared to laparoscopy (p<0.0001). However, no significant difference was observed between both beginners and competent or increasing number of trials for both DoT and D.

Conclusions: The learning curve for Endo 360 is shorter than standard laparoscopy for beginners, but not for more advanced surgeons. It is consistently associated with significantly less time for suturing and knot tying for surgeons across varied level of skill set. This  comes at the expense of accuracy with standard laparoscopy associated with more dots on target and less total deviation from targets. However, the validity of such metrics in clinical environment remains to be validated.