The satisfaction rates with currently available mechanical staplers were low. Japanese surgeons with small hands felt more stress when using the staplers. Ergonometric consideration is necessary in stapler design.
BackgroundThe clinical benefit of cetuximab combined with oxaliplatin-based chemotherapy remains under debate. The aim of the present multicenter open-label Phase II study was to explore the efficacy and safety of biweekly administration of cetuximab and mFOLFOX-6 or XELOX as first-line chemotherapy in patients with metastatic colorectal cancer.MethodsSixty-two patients with previously untreated KRAS/BRAF wild-type metastatic colorectal cancer were recruited to the study between April 2010 and May 2011. Patients received one of two treatment regimens, either cetuximab plus mFOLFOX-6 (FOLFOX + Cmab) or cetuximab plus biweekly XELOX (XELOX + Cmab), according to their own preference. Treatment was continued until disease progression or the appearance of intolerable toxicities. The primary endpoint was response rate; secondary endpoints were progression-free survival, overall survival, disease control rate, dose intensity, conversion rate to surgical resection, and safety.ResultsThe response rates in the FOLFOX + Cmab (n = 37) and XELOX + Cmab (n = 25) groups were 64.9 % (24/37) and 72.0 % (18/25), respectively. The median PFS in the FOLFOX + Cmab and XELOX + Cmab groups was 13.1 months (95 % confidence interval [CI] 12.1–17.5) and 13.4 months (95 % CI 10.1–17.9), respectively. Neutropenia was the most frequent grade 3/4 adverse event in both groups (33.9 %), followed by anorexia, acneiform eruption, skin fissure and paronychia. A waterfall plot of tumor diameter showed prominent shrinkage of the tumors in 88.7 % of patients.ConclusionsThe results of the present study indicate that biweekly cetuximab plus mFOLFOX-6/XELOX is an effective and tolerable treatment regimen. Biweekly administration of cetuximab requires only one hospital visit every 2 weeks, and may become a convenient treatment option for patients with KRAS/BRAF wild-type metastatic colorectal cancer.Trial registrationThis study is registered with University Hospital Medical Information Network (UMIN 000003253). Registration date is 02/24/2010.Electronic supplementary materialThe online version of this article (doi:10.1186/s12885-015-1685-z) contains supplementary material, which is available to authorized users.
Purpose The satisfaction rating of currently available mechanical staplers for Japanese surgeons with small hands is low. To identify the issue, we examined the relationship of hand dimensions and grip force with the operation force of a mechanical circular stapler. Methods Hand dimensions and grip force were measured in 113 Japanese surgeons (52 men and 61 women). We then evaluated the relationship between grip width and the operation force required to push the lever of the stapler, at three points on the lever, using a digital force gauge. Results The optimal grip width of the dominant hand was 62.5 ± 8.5 mm for men and 55.5 ± 5.9 mm for women (p \ 0.001). The maximum grip force of the dominant hand was 44.2 ± 6.1 kg for men and 29.7 ± 4.5 kg for women (p \ 0.001) and the maximum operation force required to push the lever 7.0, 45.0, and 73.0 mm from the end of the lever was 21.8, 28.6, and 42.4 kg, respectively. Conclusions To our knowledge, this is the first ergonomic study of a surgical stapler to be conducted in Asia. Firing the stapler by gripping the proximal side of the lever is physically impossible for most Japanese women surgeons since the required operation force exceeds the maximum grip force, which probably accounts for the stress perceived by these women.
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