Department of Surgery, Kampala International University Western Campus, Ishaka, Uganda.
Endocrinology Unit, Department of Surgery, Mulago National Referral Hospital, Kampala, Uganda.
Trials. 2023 May 31;24(1):368. doi: 10.1186/s13063-023-07387-w.
Endemic goiter is highly prevalent in Uganda at 60.2%, contributing to the high surgical burden. While compelling evidence suggest that in selected cases, thyroidectomy under local anesthesia (LA) is associated with fewer post-operative complications, low costs, and short hospital stays, local anesthesia is not considered a priority technique for thyroidectomy in resource-constrained settings such as Uganda, despite having fewer general anesthesia (GA) and critical care providers. The objective of this trial is to compare euthyroidectomy under local versus general anesthesia among patients with grade 1-2 uncomplicated euthyroid goiter in Uganda.
This prospective equivalence randomized, single-blind controlled trial protocol will be conducted among eligible participants with grade 1-2 uncomplicated euthyroid goiters. The recruitment processes will start in October 2022 and end in April 2023. Consenting participants with an indication for thyroidectomy will be randomized into two arms of 29 participants in each arm during the Bulamu Health Care Organization surgical camps in Uganda.
The primary outcome of this trial protocol is to compare the early post-operative complications of euthyroidectomy done under LA versus GA. The outcome variables include post-operative pain based on visual analogue scale, nausea, vomiting, hematoma formation, and transient voice changes determined at an interval of 6, 12, and 24 h and at 30 days. In addition, we shall compare the surgical site infection rates, procedure costs, hospital stay, and patients' level of satisfaction based on a 5-point Likert scale and their willingness to undergo a similar surgery using the same anesthetic technique between the two groups. We hypothesize that euthyroidectomy under LA could potentially offer similar benefits as GA, reduce costs related to procedure, complications, and hospital stay while at the same time mitigating the unmet need for surgery attributable to shortage of general anesthesia providers and critical care facilities in low-income settings.
Pan African Clinical Trial Registry PACTR202208635457430. Registered on 11 August 2022. All items from the WHO trial registration data set are within the protocol. Version number and date: version 3, 15/03/2023.
地方性甲状腺肿在乌干达的患病率高达 60.2%，这是导致手术负担沉重的主要原因。有确凿的证据表明，在某些情况下，局部麻醉（LA）下的甲状腺切除术与较少的术后并发症、较低的成本和较短的住院时间相关，但在资源有限的环境中，如乌干达，局部麻醉并未被视为甲状腺切除术的优先技术，尽管那里的全身麻醉（GA）和重症监护提供者较少。本试验的目的是比较局部麻醉与全身麻醉在乌干达 1-2 级无并发症单纯性甲状腺肿患者中的效果。
本前瞻性等效随机、单盲对照试验方案将在符合条件的 1-2 级无并发症单纯性甲状腺肿患者中进行。招募过程将于 2022 年 10 月开始，2023 年 4 月结束。在乌干达 Bulamu 医疗保健组织的外科营地中，对有甲状腺切除术指征的同意参与者进行随机分组，每组 29 人。
本试验方案的主要结果是比较 LA 与 GA 下进行的甲状腺切除术的早期术后并发症。结果变量包括术后 6、12 和 24 小时以及 30 天时基于视觉模拟量表的术后疼痛、恶心、呕吐、血肿形成和短暂性声音变化，以及根据 5 分李克特量表评估的手术部位感染率、手术费用、住院时间和患者满意度，以及他们是否愿意使用相同的麻醉技术接受类似的手术。我们假设 LA 下的甲状腺切除术可能具有与 GA 相似的益处，可以降低与手术、并发症和住院时间相关的成本，同时缓解由于中低收入环境中全身麻醉提供者和重症监护设施短缺而导致的未满足的手术需求。
泛非临床试验注册中心 PACTR202208635457430。于 2022 年 8 月 11 日注册。世界卫生组织试验注册数据集中的所有项目均在方案内。版本号和日期：第 3 版，2023 年 3 月 15 日。
