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A Pilot Study of Local Anesthesia for Inguinal Hernia Surgery in Older Adults

老年人腹股沟疝气手术局部麻醉的初步研究

基本信息

批准号：
10697398
负责人：
Courtney J Balentine
金额：
$ 24.02万
依托单位：
UNIVERSITY OF WISCONSIN-MADISON
依托单位国家：
美国
项目类别：
财政年份：
2021
资助国家：
美国
起止时间：
2021-09-01 至 2025-08-31
项目状态：
未结题

来源：
https://reporter.nih.gov/project-details/10697398
关键词：
Acceleration Admission activity Adult Age Aging Agreement American American College of Surgeons Anesthesia procedures Anesthetics Caregivers Caring Clinical Trials Cognitive Cohort Studies Country Data Databases Elderly Eligibility Determination Enrollment Exposure to Funding General Anesthesia Geriatrics Goals Health system Hernia Hospital Administrators Hospitals Impaired cognition Individual Inguinal Hernia Institution Interview Knowledge Local anesthesia Measures Morbidity - disease rate Nurses Operative Surgical Procedures Outcome Outcome Assessment Outcome Measure Outcome Study Participant Patient-Focused Outcomes Patients Physical Function Physicians Pilot Projects Population Positioning Attribute Postoperative Complications Procedures Provider Quality of life Randomized Recovery Research Personnel Resources Site Societies Structure Surgeon System Target Populations Techniques Testing Time Training United States Department of Veterans Affairs aged arm career clinical trial analysis cognitive function comorbidity cost design functional status human old age (65+)implementation science improved improved outcome instrument member multi-site trial older patient operation pilot trial postoperative recovery professor prospective randomized trial recruit repaired surgical research trial comparing

项目摘要

Inguinal hernia repair – the most common general surgery operation in the U.S. – provides a unique opportunity to improve outcomes for older adults by changing surgical practice. Nearly 80% of inguinal hernia operations are performed under general anesthesia versus 15%-20% using local anesthesia. Although some studies suggest that exposure to general anesthesia can cause cognitive and physical decline in older adults, the evidence for choosing an anesthesia technique for inguinal hernia repair in older adults is inconclusive. Several studies demonstrated that using local anesthesia for hernia repair reduced morbidity by one-third, unplanned admissions by 20%, and operative time and costs by 15%, while other studies showed no significant differences. Unfortunately, these studies have significant shortcomings that limit their applicability for older adults, and our preliminary data suggest that the benefits of local anesthesia increase with age. The applicant is an assistant professor in surgery whose long-term career goal is to use expertise in implementation science and clinical trials to promote patient-centered outcomes for older adults before, during, and after surgery. The project goal is to obtain preliminary data to support a multisite trial comparing general versus local anesthesia for inguinal hernia repair in adults aged 65 years and older. We hypothesize that using local rather than general anesthesia for inguinal hernia repair in older adults will reduce morbidity and enhance quality of life. We propose the following specific aims: (1) Identify the optimal target population for a pilot study of general versus local anesthesia among patients aged 65 and older who are undergoing inguinal hernia repair. We will use a national database of operations in the Veterans Affairs system to determine which subsets of older patients (age, comorbidity, and functional status) are most likely to have complications or prolonged operative and recovery time with general anesthesia. (2) Determine which outcomes of inguinal hernia repair are most relevant to patients, caregivers, providers, and hospital administrators for a pilot trial of local versus general anesthesia for hernia repair in older adults. We will interview stakeholders to identify outcomes valued by each group. (3) Conduct a pilot study to assess and refine study procedures and determine feasibility of recruitment, randomization, and retention for a multisite randomized trial of local versus general anesthesia in older adults having inguinal hernia surgery. We will conduct a pilot randomized trial of local versus general anesthesia (30 patients/arm) targeting the population identified in aim 1 and assessing outcomes from aim 2. We will measure rates of enrollment among eligible patients, assess acceptability of study instruments, and verify our ability to follow patients and measure outcomes at each time point. Expected outcomes of the study are (1) crucial preliminary data for planning and executing a multisite trial comparing general versus local anesthesia for hernia repair in older adults, and (2) training and knowledge necessary for the applicant to become a leader in surgical research.

腹股沟疝修补术-在美国最常见的普通外科手术-提供了一个独特的通过改变手术实践来改善老年人的结果。近80%的腹股沟疝手术在全身麻醉下进行，而15%-20%使用局部麻醉。尽管一些研究表明暴露于全身麻醉可导致老年人的认知和身体衰退，老年人腹股沟疝修补术麻醉技术的选择尚无定论。几项研究表明，使用局部麻醉进行疝修补术可将发病率降低三分之一，计划外入院减少20%，手术时间和成本减少15%，而其他研究表明，显著差异。不幸的是，这些研究有明显的缺点，限制了它们的适用性，我们的初步数据表明，局部麻醉的好处随着年龄的增长而增加。申请人是外科助理教授，其长期职业目标是利用专业知识，实施科学和临床试验，以促进老年人以患者为中心的结果之前，期间，手术后也是如此该项目的目标是获得初步数据，以支持多中心试验，与局部麻醉用于65岁及以上成人腹股沟疝修补术的比较。我们假设在老年人腹股沟疝修补术中使用局部麻醉而不是全身麻醉将降低发病率，提高生活质量。我们提出了以下具体目标：（1）确定最佳目标人群，一项在65岁及以上接受手术的患者中进行的全身麻醉与局部麻醉的初步研究腹股沟疝修补术。我们将使用退伍军人事务系统的国家行动数据库，确定老年患者的哪些子集（年龄、合并症和功能状态）最有可能发生全身麻醉的并发症或手术和恢复时间延长。(2)确定哪些腹股沟疝修补术的结局与患者、护理人员、提供者和医院最相关管理人员进行了一项关于局部麻醉与全身麻醉用于老年人疝修补术的试点试验。我们将与利益相关者进行访谈，以确定每个群体所重视的成果。(3)开展试点研究，评估并完善研究程序，确定招募、随机化和保留的可行性，局部麻醉与全身麻醉在老年腹股沟疝患者中的多中心随机试验手术我们将进行一项局部麻醉与全身麻醉（30例患者/组）的初步随机试验，目标1中确定的人口，并评估目标2的成果。我们将测量入学率在合格患者中，评估研究工具的可接受性，并验证我们随访患者的能力，测量每个时间点的结果。研究的预期成果是：（1）关键的初步数据，计划并实施一项多中心试验，比较全身麻醉与局部麻醉用于老年人疝修补术成人，和（2）培训和知识，申请人成为外科研究的领导者所必需的。

项目成果

期刊论文数量（6）

专著数量（0）

科研奖励数量（0）

会议论文数量（0）

专利数量（0）

Chief Residents Can Safely Operate on Older and Frail Patients.

DOI：
10.1016/j.jss.2022.12.005
发表时间：
2023-05
期刊：
JOURNAL OF SURGICAL RESEARCH
影响因子：
2.2
作者：
Meier, Jennie;Stevens, Audrey;Nunez, Johanna;Jacob, Alison;Garza, Amanda;Bisgaard, Erika;Abdelfattah, Kareem;Balentine, Courtney
通讯作者：
Balentine, Courtney

Determining the Power Required for Comparing Lobectomy vs Total Thyroidectomy for Papillary Thyroid Carcinoma.

确定比较甲状腺乳头状癌的肺叶切除术与甲状腺全切除术所需的功率。

DOI：
10.1001/jamasurg.2023.1060
发表时间：
2023
期刊：
JAMA surgery
影响因子：
16.9
作者：
Balentine,Courtney
通讯作者：
Balentine,Courtney

Age is associated with increased morbidity after laparoscopic appendectomy.

DOI：
10.1016/j.surg.2022.04.008
发表时间：
2022-08
期刊：
SURGERY
影响因子：
3.8
作者：
Stevens, Audrey;Meier, Jennie;Bhat, Archana;Bhat, Sneha;Balentine, Courtney
通讯作者：
Balentine, Courtney

Is nonoperative management of appendicitis safe and effective in multi-morbid patients?

对于多病患者，阑尾炎的非手术治疗安全有效吗？

DOI：
10.1016/j.surg.2023.10.017
发表时间：
2024
期刊：
Surgery
影响因子：
3.8
作者：
Lunardi,Nicole;Meier,Jennie;Pham,ThaiH;Zarzaur,BenL;Agarwal,Suresh;Sharath,Sherene;Kougias,Panos;Balentine,CourtneyJ
通讯作者：
Balentine,CourtneyJ

Reassessing surgical guidelines for papillary thyroid cancer impact on survival: Expanding indications for lobectomy.

重新评估甲状腺乳头状癌手术指南对生存的影响：扩大肺叶切除术的适应症。

DOI：
10.1016/j.surg.2023.05.033
发表时间：
2023
期刊：
Surgery
影响因子：
3.8
作者：
Stevens,Audrey;Meier,Jennie;Bhat,Archana;Knight,SaraJ;Vanness,DavidJ;Balentine,Courtney
通讯作者：
Balentine,Courtney