ABVENTURE-P pilot trial of physical therapy versus standard of care following ventral hernia repair: Protocol for a randomized controlled trial.
ABVENTURE-P pilot trial of physical therapy versus standard of care following ventral hernia repair: Protocol for a randomized controlled trial.
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DOI：
10.1371/journal.pone.0289038
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发表时间：
2023
期刊：
影响因子：
3.7
通讯作者：
中科院分区：
文献类型：
--
作者：
疝病是患者寻求手术治疗的最常见原因之一，但在美国，近四分之一寻求腹疝修补术的患者患有慢性疼痛，残疾和体力活动减少。前腹壁、下背部、横膈膜和骨盆底之间的关系在提供功能和生活质量方面至关重要，但疝疾病的管理仅限于解剖结构的手术恢复，而没有考虑到腹部核心的功能关系。因此，本研究的主要目的是评估实施物理治疗以改善该人群的稳定性和功能的可行性。第二个目标是评估术前腹部核心功能是否能预测对物理治疗的反应。本研究是一项基于登记的随机对照试验（NCT 05142618：腹芯康复改善腹股沟疝修补术后结局的初探性试验（ABVENTURE-P））。所有受试者将被随机分配到两个术后治疗组之一：标准治疗加最多16次物理治疗，或仅标准治疗。主要时间点包括术前（基线）和术后10周，中间或次要时间点为术后30天、6个月和1年。在每个时间点，受试者将接受功能和患者报告的结局测试。我们还将收集关于留存率和治疗依从性的数据。所有分析计划采用意向治疗方法，使用所有随机化且在10周时间点有可用数据的受试者。这是一项初步可行性试验，因此我们的目标是确定PT干预的安全性和初步疗效，PT和对照组的保留和依从性，术前腹部核心功能是否可预测PT的反应性，并收集足够大的样本以支持未来的确定性多中心随机对照试验。
Hernia disease is one of the most common reasons patients seek surgical treatment, yet nearly 1 in 4 patients seeking ventral hernia repair in the United States suffer from chronic pain, disability, and diminished physical activity. The relationships between the anterior abdominal wall, lower back, diaphragm, and pelvic floor are critical in providing function and quality of life, yet management of hernia disease has been limited to surgical restoration of anatomy without taking into consideration the functional relationships of the abdominal core. Therefore, the primary goal of this study is to evaluate the feasibility of implementing physical therapy targeted to improving stability and function in this population. A secondary goal is to estimate whether pre-operative abdominal core function predicts responsiveness to physical therapy. This study is a registry-based randomized controlled trial (NCT05142618: Pilot Trial of Abdominal Core Rehabilitation To Improve Outcomes After Ventral Hernia Repair (ABVENTURE-P)). All participants will be randomized to one of two post-operative treatment arms: standard of care plus up to 16 sessions of physical therapy, or standard of care alone. Primary timepoints include pre-operative (baseline) and ten weeks after surgery, with intermediate or secondary timepoints 30 days, 6 months, and 1 year post-operative. At each timepoint, participants will undergo functional and patient-reported outcome testing. We will also collect data on retention rate and treatment adherence. An intention to treat approach is planned for all analyses, using all participants who were randomized and have available data at the 10-week timepoint. This is a pilot and feasibility trial, hence our goals are to establish safety and initial efficacy of the PT intervention, retention and adherence to both PT and control arms, whether pre-operative abdominal core function predicts responsiveness to PT, and to collect a large enough sample to power a future definitive multi-center randomized controlled trial.
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