Prospective RCT of Obstructed Defecation Surgery: Comparing Transvaginal Rectopexy, Ventral Mesh Rectopexy and POP Repair (PROD Trial)

排便梗阻手术的前瞻性随机对照试验：比较经阴道直肠固定术、腹侧网状直肠固定术和 POP 修复术（PROD 试验）

• 批准号: 10660169
• 负责人: Ghazaleh Rostami Nia
• 金额: $ 62.85万
• 依托单位: NORTHSHORE UNIVERSITY HEALTHSYSTEM
• 依托单位国家: 美国
• 财政年份: 2023
• 资助国家: 美国
• 起止时间: 2023-04-01 至 2028-02-29
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10660169
• 关键词: Abdomen; Adult; Anatomy; Anus; Ataxia; Caring; Case Series; Chronic; Clinic; Clinical; Clinical Data; Clinical Trials; Complement; Computer Models; Constipation; Data; Dedications; Defecation; Defecography; Defect; Diagnosis; Diagnostic; Diagnostic Procedure; Disease; Effectiveness; Elements; Evaluation; Feces; Female; Foundations; Frequencies; Goals; Healthcare; Impairment; Institution; Intestines; Ligaments; Magnetic Resonance Imaging; Manometry; Manuals; Measures; Mechanics; Methods; Modality; Modeling; Morbidity - disease rate; Operative Surgical Procedures; Outcome; Patients; Pelvic floor structure; Pelvis; Physics; Procedures; Ptosis; Publications; Publishing; Quality of life; Randomized; Rectal Prolapse; Rectocele; Rectum; Research; Role; Shapes; Source; Surgical incisions; Symptoms; Testing; Treatment outcome; Ultrasonography; Vagina; Vaginal Prolapses; Woman; Women' s Health; Work; care burden; design; diagnostic strategy; follow-up; health related quality of life; implantation; improved; improved outcome; insight; minimally invasive; novel; novel diagnostics; novel strategies; operation; pressure; primary outcome; prospective; rectal; repaired; secondary outcome; standard of care; ultrasound

Obstructed defecation (OD), defined as incomplete emptying of stool, is a widely prevalent disorder in women’s health and resulting in major quality of life (QOL) and healthcare burden. Successful management has been impaired, historically, by deficiencies relating to both diagnosis and treatment. First, there has been a persistent misconception that OD in the absence of dyssynergia (i.e., uncoordinated contraction of pelvic floor) results from prolapse of the posterior vaginal wall (‘rectocele’) and improves after its repair. In fact, prior studies have confirmed that this form of OD results from support defects involving the rectum rather than vagina (8-10), and moreover that rectocele repairs are unreliable in relieving OD symptoms. Recent work from our center confirmed rectal detachment and hypermobility to be the major determinants of OD in the irrespective of the presence of a rectocele. Secondly, traditional diagnostic modalities to asses rectal support as the source of OD are expensive (e.g. MRI defecography) and/or invasive (e.g. anal manometry), and often generate findings with unclear clinical correlation and impact on care. Finally, available surgeries to repair rectal support defects have been limited to invasive transabdominal or perineal methods, typically involving mesh implantation and reserved for severe cases, e.g. those with overt rectal prolapse. Laparoscopic or open ventral mesh rectopexy is the most widely accepted operation to stabilize rectal support. We are testing the hypothesis that OD symptoms in the absence of dyssynergia primarily result from deficiencies in rectal support and that patients presenting OD symptoms with or without vaginal prolapse undergoing our new diagnostic evaluation and surgical treatment will have improved outcomes relative to the current standard of care at 2 years after surgery. Our study is designed to evaluate primary and secondary outcomes relating to the two rectopexy procedures on OD at 2 years follow up across two institutions. This clinical data will be complemented by a computational modeling approach that aims to provide insight into the most likely contributors to OD symptoms, i.e. vaginal versus rectal support defects. Aim 1: Compare occult rectal hypermobility as measured using posterior compartment dynamic ultrasound imaging versus MR defecography. Posterior compartment dynamic ultrasound is a novel approach for identifying the underlying anatomic cause of OD in women suffering from OD symptoms without coexisting functional bowel disorders (e.g. normal BM frequency and stool type, and absence of dyssynergia). Aim 2: Compare anatomic, functional, and health-related quality of life outcomes in female subjects with moderate to severe OD symptoms, and rectal hypermobility diagnosed by ultrasound, who are randomized to minimally invasive transvaginal rectopexy versus abdominal ventral rectopexy at 2 years after surgery. Aim 3: Develop and validate a computational finite element model and statistical shape modeling approach to describe the mechanics of normal defecation and the role of rectal and vaginal support deficiencies in causing OD symptoms.

排便障碍（OD），定义为粪便排空不完全，是一种广泛流行的 女性健康的障碍，并导致主要的生活质量（QOL）和医疗保健负担。 从历史上看，成功的管理一直受到与这两方面有关的缺陷的影响。 诊断和治疗。首先，一直有一个误解，即OD在 不存在协同失调（即，骨盆底不协调的收缩）由脱垂引起， 阴道后壁（“直肠前突”），并在修复后改善。事实上，之前的研究 证实这种形式的OD是由于涉及直肠的支撑缺陷而不是 阴道（8-10），而且直肠前突修复术在缓解OD症状方面是不可靠的。 我们中心最近的工作证实直肠脱离和过度活动是主要的 决定OD的因素，无论是否存在直肠前突。其次，传统 评估作为OD来源的直肠支持的诊断方式是昂贵的（例如MRI 排粪造影术）和/或侵入性（例如肛门测压），并经常产生不清楚的结果 临床相关性和对护理的影响。最后，可用手术修复直肠支撑 缺陷仅限于侵入性经腹或会阴方法，通常涉及 补片植入，并保留用于严重病例，例如明显的直肠脱垂。 腹腔镜或开放式腹侧网状直肠固定术是最广泛接受的手术，以稳定 直肠支持 我们正在测试的假设，即在没有协同失调的情况下， 由于直肠支持的缺陷，患者表现出OD症状， 如果没有阴道脱垂，接受我们新的诊断评估和手术治疗， 在术后2年时，相对于当前的护理标准，结果有所改善。我们 本研究旨在评价与两种直肠固定术相关的主要和次要结局 两个机构2年随访时的OD程序。这些临床数据将 辅以计算建模方法，旨在提供最深入的洞察力 可能导致OD症状，即阴道与直肠支撑缺陷。目标1：比较 后室动态超声成像测量隐性直肠运动过度 对比磁共振排粪造影。后室动态超声是一种新的方法， 确定患有OD症状的女性中OD的潜在解剖学原因， 共存的功能性肠病（例如正常的BM频率和粪便类型，以及缺乏 协同失调）。目的2：比较解剖、功能和健康相关的生活质量结局 在患有中度至重度OD症状的女性受试者中，通过以下方法诊断为直肠运动过度 超声，随机接受微创经阴道直肠固定术与经腹 术后2年腹侧直肠固定术。目标3：开发和验证计算有限 单元模型和统计形状建模方法来描述正常的力学 排便以及直肠和阴道支撑缺陷在引起OD症状中的作用。