Background

Risk of mortality following surgery in patients across Africa is twice as high as the global average. Most of these deaths occur on hospital wards after the surgery itself. We aimed to assess whether enhanced postoperative surveillance of adult surgical patients at high risk of postoperative morbidity or mortality in Africa could reduce 30-day in-hospital mortality.

Methods

We did a two-arm, open-label, cluster-randomised trial of hospitals (clusters) across Africa. Hospitals were eligible if they provided surgery with an overnight postoperative admission. Hospitals were randomly assigned through minimisation in recruitment blocks (1:1) to provide patients with either a package of enhanced postoperative surveillance interventions (admitting the patient to higher care ward, increasing the frequency of postoperative nursing observations, assigning the patient to a bed in view of the nursing station, allowing family members to stay in the ward, and placing a postoperative surveillance guide at the bedside) for those at high risk (ie, with African Surgical Outcomes Study Surgical Risk Calculator scores ≥10) and usual care for those at low risk (intervention group), or for all patients to receive usual postoperative care (control group). Health-care providers and participants were not masked, but data assessors were. The primary outcome was 30-day in-hospital mortality of patients at low and high risk, measured at the participant level. All analyses were done as allocated (by cluster) in all patients with available data. This trial is registered with ClinicalTrials.gov, NCT03853824.

Findings

Between May 3, 2019, and July 27, 2020, 594 eligible hospitals indicated a desire to participate across 33 African countries; 332 (56%) were able to recruit participants and were included in analyses. We allocated 160 hospitals (13 275 patients) to provide enhanced postoperative surveillance and 172 hospitals (15 617 patients) to provide standard care. The mean age of participants was 37·1 years (SD 15·5) and 20 039 (69·4%) of 28 892 patients were women. 30-day in-hospital mortality occurred in 169 (1·3%) of 12 970 patients with mortality data in the intervention group and in 193 (1·3%) of 15 242 patients with mortality data in the control group (relative risk 0·96, 95% CI 0·69–1·33; p=0·79). 45 (0·2%) of 22 031 patients at low risk and 309 (5·6%) of 5500 patients at high risk died. No harms associated with either intervention were reported.

Interpretation

This intervention package did not decrease 30-day in-hospital mortality among surgical patients in Africa at high risk of postoperative morbidity or mortality. Further research is needed to develop interventions that prevent death from surgical complications in resource-limited hospitals across Africa.

Funding

Bill & Melinda Gates Foundation and the World Federation of Societies of Anaesthesiologists.

Translations

For the Arabic, French and Portuguese translations of the abstract see Supplementary Materials section.

中文翻译：

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增强术后监测与标准护理以降低非洲成人手术患者的死亡率 (ASOS-2)：一项整群随机对照试验

背景

非洲患者手术后死亡的风险是全球平均水平的两倍。这些死亡大多数发生在手术后的医院病房里。我们旨在评估加强对非洲术后发病率或死亡率高风险的成年手术患者的术后监测是否可以降低 30 天院内死亡率。

方法

我们对整个非洲的医院（集群）进行了一项双臂、开放标签、集群随机试验。如果医院提供手术并在术后过夜，则符合条件。通过最小化招募块 (1:1) 随机分配医院，为患者提供一揽子增强的术后监测干预措施（将患者纳入更高的护理病房，增加术后护理观察的频率，将患者分配到护理站的视图，允许家属留在病房，并在床边放置术后监测指南）对高危患者（即，非洲手术结果研究手术风险计算器评分≥10）和常规护理低风险（干预组），或所有患者接受常规术后护理（对照组）。卫生保健提供者和参与者没有被屏蔽，但数据评估员被屏蔽了。主要结果是低风险和高风险患者的 30 天院内死亡率，在参与者级别进行测量。所有分析都是在所有具有可用数据的患者中按分配（按集群）进行的。该试验已在 ClinicalTrials.gov 注册，NCT03853824。

发现

2019 年 5 月 3 日至 2020 年 7 月 27 日期间，594 家符合条件的医院表示希望参与 33 个非洲国家；332 (56%) 名能够招募参与者并被纳入分析。我们分配了 160 家医院（13 275 名患者）提供增强的术后监测，并分配了 172 家医院（15 617 名患者）提供标准护理。参与者的平均年龄为 37·1 岁 (SD 15·5)，28 892 名患者中有 20 039 (69·4%) 名女性。干预组 12 970 名有死亡数据的患者中有 169 名 (1·3%) 发生了 30 天院内死亡，而对照组的 15 242 名有死亡数据的患者中有 193 名 (1·3%)（相对风险0·96，95% CI 0·69–1·33；p=0·79）。22 031 名低风险患者中的 45 名 (0·2%) 和 5500 名高风险患者中的 309 名 (5·6%) 死亡。没有报告与任何一种干预相关的危害。

解释

该干预方案并未降低非洲术后发病率或死亡率高风险的手术患者的 30 天院内死亡率。需要进一步研究以制定干预措施，以防止整个非洲资源有限的医院因手术并发症而死亡。

资金

比尔和梅琳达盖茨基金会和世界麻醉师学会联合会。

翻译

有关摘要的阿拉伯语、法语和葡萄牙语翻译，请参阅补充材料部分。