Chaudhary Neeraj, Varma Vibha, Kapoor Sorabh, Mehta Naimish, Kumaran Vinay, Nundy Samiran
Department of Surgical Gastroenterology and Liver Transplantation, Sir Ganga Ram Hospital, Room No 1474, Casualty Block, Old Rajinder Nagar, New Delhi, 110060, India,
J Gastrointest Surg. 2015 May;19(5):935-42. doi: 10.1007/s11605-015-2772-9. Epub 2015 Feb 18.
The implementation of a surgical safety checklist is said to minimize postoperative surgical complications. However, to our knowledge, no randomized controlled study has been done on the influence of checklists on postoperative outcomes in a developing country. We conducted a prospective randomized controlled study with parallel group study design of the implementation of WHO surgical safety checklist involving 700 consecutive patients undergoing operations in our hospital between February 2012 and April 2013. In 350 patients, the checklist was implemented with modifications-the Rc arm. The control group of 350 patients was termed the Rn arm. The checklist was filled in by a surgery resident, and only the participants in the study were blinded. Postoperative wound-related (p = 0.04), abdominal (p = 0.01), and bleeding (p = 0.03) complications were significantly lower in the Rc compared to the Rn group. The number of overall and higher-grade complications (Clavien-Dindo grades 3 and 4) per patient reduced from 0.97 and 0.33 in the Rn arm to 0.80 and 0.23 in the Rc arm, respectively. A significant reduction in mortality was noted in the Rc arm as compared to the Rn arm (p = 0.04). In a subgroup analysis, the number of overall and higher-grade complications per patient with incomplete checklists was higher than that with fully completed checklist group. Implementation of WHO surgical safety checklist results in a reduction in mortality as well as improved postoperative outcomes in a tertiary care hospital in a developing country.
据说实施手术安全检查表可将术后手术并发症降至最低。然而,据我们所知,尚未在发展中国家进行关于检查表对术后结果影响的随机对照研究。我们进行了一项前瞻性随机对照研究,采用平行组研究设计,对2012年2月至2013年4月期间在我院连续接受手术的700例患者实施世界卫生组织手术安全检查表。在350例患者中,检查表进行了修改后实施——即Rc组。350例患者的对照组称为Rn组。检查表由外科住院医师填写,只有研究参与者被设盲。与Rn组相比,Rc组术后伤口相关并发症(p = 0.04)、腹部并发症(p = 0.01)和出血并发症(p = 0.03)明显更低。每位患者的总体并发症和更高级别并发症(Clavien-Dindo 3级和4级)数量分别从Rn组的0.97和0.33降至Rc组的0.80和0.23。与Rn组相比,Rc组的死亡率显著降低(p = 0.04)。在亚组分析中,检查表填写不完整的患者每位的总体并发症和更高级别并发症数量高于检查表完全填写的组。在发展中国家的一家三级医院实施世界卫生组织手术安全检查表可降低死亡率并改善术后结果。