BACKGROUND: Needleholders with in-line handles (ILH) and those with pistol-grip handles (PGH) were compared in terms of operative end-product quality (OEPQ), procedure effectiveness (PE), and surgeon forearm workload (SFWL) during suturing in a laparoscopic simulator. METHODS: A 90% power crossover design at alpha 0.05 required 46 surgeons. Block randomization generated ILH-PGH or PGH-ILH sequence allocation. The task involved suturing a perforated ulcer on a foam stomach in a simulator. In this study, OEPQ was measured by tissue damage, accuracy error, water leak; PE by operating time and motion analysis including goal-directed actions (GDA) and non-goal-directed actions (NGDA); and SFWL by electromyogram (EMG) of six forearm and thumb muscles. RESULTS: The 46 surgeons performed the tasks as allocated. All the variables but two were significantly different between the first and second tasks, ignoring the handle type. There was no evidence of an unequal carryover effect when the comparison was stratified by ILH-PGH or PGH-ILH sequence. As compared with ILH, PGH tissue damage (0.1 vs 0.2 mm; p = 0.06) and NGDA (1 vs 1 p = 0.09) were different, whereas accuracy error, leak rates, operating time, GDA, and EMG were not. CONCLUSIONS: As compared with ILH needleholders, the use of PGH needleholders led to increased tissue damage and non-goal-directed actions during a suturing task in a simulator.
RCT Entities:
BACKGROUND: Needleholders with in-line handles (ILH) and those with pistol-grip handles (PGH) were compared in terms of operative end-product quality (OEPQ), procedure effectiveness (PE), and surgeon forearm workload (SFWL) during suturing in a laparoscopic simulator. METHODS: A 90% power crossover design at alpha 0.05 required 46 surgeons. Block randomization generated ILH-PGH or PGH-ILH sequence allocation. The task involved suturing a perforated ulcer on a foam stomach in a simulator. In this study, OEPQ was measured by tissue damage, accuracy error, water leak; PE by operating time and motion analysis including goal-directed actions (GDA) and non-goal-directed actions (NGDA); and SFWL by electromyogram (EMG) of six forearm and thumb muscles. RESULTS: The 46 surgeons performed the tasks as allocated. All the variables but two were significantly different between the first and second tasks, ignoring the handle type. There was no evidence of an unequal carryover effect when the comparison was stratified by ILH-PGH or PGH-ILH sequence. As compared with ILH, PGH tissue damage (0.1 vs 0.2 mm; p = 0.06) and NGDA (1 vs 1 p = 0.09) were different, whereas accuracy error, leak rates, operating time, GDA, and EMG were not. CONCLUSIONS: As compared with ILH needleholders, the use of PGH needleholders led to increased tissue damage and non-goal-directed actions during a suturing task in a simulator.
Authors: Gyusung Lee; Tommy Lee; David Dexter; Carlos Godinez; Nora Meenaghan; Robert Catania; Adrian Park Journal: Surg Endosc Date: 2008-09-25 Impact factor: 4.584