Department of Visceral Surgery and Medicine, Inselspital, Bern University Hospital, University of Bern, Bern, Switzerland.
Institute for Work and Organizational Psychology, University of Neuchâtel, Neuchâtel, Switzerland.
Trials. 2022 Oct 18;23(1):878. doi: 10.1186/s13063-022-06775-y.
Surgical care, which is performed by intensely interacting multidisciplinary teams of surgeons, anesthetists, and nurses, remains associated with significant morbidity and mortality. Intraoperative communication has been shown to be associated with surgical outcomes, but tools ensuring efficient intraoperative communication are lacking. In a previous study, we developed the StOP?-protocol that fosters structured intraoperative communication. Before the critical phases of the operation, the responsible surgeon initiates and leads one or several StOP?s. During a StOP?, the surgeon informs about the progress of the operation (status), next steps and proximal goals (objectives), and possible problems (problems) and encourages all team members to voice their observations and ask questions (?). In a before-after study performed mainly in visceral surgery, we found effects of the StOP?-protocol on mortality, length of hospital stay, and reoperation. We intend to assess the impact of the StOP?-protocol in a cluster randomized trial, in a wider variety of surgical specialties (i.e., general, visceral, thoracic, vascular surgery, surgical urology, and gynecology). The primary hypothesis is that the consistent use of the StOP?-protocol by the main surgeon reduces patient mortality within 30 days after the operation. The secondary hypothesis is that the consistent use of the StOP?-protocol by the main surgeon reduces unplanned reoperations, length of hospital stay, and unplanned hospital readmissions.
This study is designed as a multicenter, cluster-randomized parallel-group trial. Board-certified surgeons of participating clinical departments will be randomized 1:1 to the StOP? intervention group or to the standard of care (control) group. The intervention group will undergo a training to use the StOP?-protocol and receive regular feedback on their compliance with the protocol. The surgeons in the control group will communicate as usual during their operations. The unit of observation will be operations performed by cluster surgeons. Consecutive patients will be enrolled over 4 months per cluster. A total of 400 surgeons will be recruited, and we expect to collect patient outcome data for 14,000 surgical procedures.
The StOP?-protocol was designed as a tool to structure communication during surgical procedures. Testing its effects on patient outcomes will contribute to implementing evidenced-based interventions to reduce surgical complications.
ClinicalTrials.gov NCT05356962. Registered on May 2, 2022.
外科手术由外科医生、麻醉师和护士等多学科团队密切合作完成，但仍与较高的发病率和死亡率相关。术中沟通已被证明与手术结果相关，但缺乏确保高效术中沟通的工具。在之前的一项研究中，我们开发了 StOP?-protocol，以促进术中的结构化沟通。在手术的关键阶段之前，负责的外科医生启动并主导一个或多个 StOP?s。在 StOP?期间，外科医生会报告手术进展（现状）、下一步和近端目标（目标）以及可能出现的问题（问题），并鼓励所有团队成员发表意见并提问（？）。在一项主要在内脏外科中进行的前后研究中，我们发现 StOP?-protocol 对死亡率、住院时间和再次手术有影响。我们打算在一项更广泛的外科专业（即普通外科、内脏外科、胸外科、血管外科、外科泌尿科和妇科）的聚类随机试验中评估 StOP?-protocol 的影响。主要假设是主刀医生持续使用 StOP?-protocol 可降低术后 30 天内的患者死亡率。次要假设是主刀医生持续使用 StOP?-protocol 可减少非计划性再次手术、住院时间和非计划性住院再入院。
本研究设计为多中心、聚类随机平行组试验。参与临床科室的认证外科医生将以 1:1 的比例随机分为 StOP?干预组或标准护理（对照组）组。干预组将接受使用 StOP?-protocol 的培训，并定期收到其遵守协议的反馈。对照组的外科医生将在手术过程中照常进行沟通。观察单位将是聚类外科医生进行的手术。每个聚类将在 4 个月内连续招募患者。预计将招募 400 名外科医生，并收集 14000 例手术的患者结局数据。
StOP?-protocol 被设计为一种在手术过程中进行沟通的工具。测试其对患者结局的影响将有助于实施基于证据的干预措施以减少手术并发症。
ClinicalTrials.gov NCT05356962。注册于 2022 年 5 月 2 日。
