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

梗阻排便(OD)是一种广泛流行的疾病，其定义是大便排空不全。 妇女健康紊乱，导致严重的生活质量和医疗负担。 从历史上看，成功的管理一直受到与两者相关的缺陷的影响 诊断和治疗。首先，人们一直有一种误解，认为吸食过量 无协同失调(即，盆底收缩不协调)是由下垂引起的 阴道后壁(直肠前突)，修复后有所改善。事实上，之前的研究已经 确认这种形式的OD是由于直肠的支持缺陷造成的，而不是 阴道(8-10)，而且直肠前突修复在缓解OD症状方面是不可靠的。 我们中心最近的研究证实直肠脱离和过度活动是主要的 与直肠前突的存在无关的OD的决定因素。其次，传统的 将直肠支持作为OD来源进行评估的诊断方法非常昂贵(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发现 临床相关性和对护理的影响。最后，修复直肠支持的可用手术 缺陷仅限于侵入性的经腹或会阴方法，通常涉及 网片植入和保留严重的情况下，例如那些明显的直肠脱垂。 腹腔镜或开腹网状直肠固定术是最广泛接受的稳定手术 直肠支持。 我们正在检验这样一种假设，即缺乏协同作用的服药过量症状主要是 由于直肠支持不足以及出现OD症状的患者或 如果没有接受我们新的诊断评估和手术治疗的阴道脱垂 与目前的护理标准相比，术后2年的结果有所改善。我们的 这项研究旨在评估与两种直肠固定术相关的主要和次要结果 服药过量的程序在两个机构中进行了两年的跟踪调查。这一临床数据将是 辅以计算建模方法，旨在提供对大多数 可能导致过多症状的因素，即阴道和直肠的支撑缺陷。目标1：比较 后室动态超声成像测量隐匿性直肠高活动度 对阵排粪造影术。后室动态超声是一种新的超声检查方法 确定患有OD症状的女性发生OD的潜在解剖学原因 共存的功能性肠病(例如，正常的BM频率和大便类型，以及缺乏 协同失调)。目标2：比较解剖、功能和健康相关的生活质量结果 在女性受试者中，有中度到重度的OD症状，并且直肠运动过度，由 超声随机分为经阴道微创直肠固定术与经腹微创直肠固定术 腹直肠固定术，术后2年。目标3：开发和验证计算有限元 描述正态力学的单元模型和统计形状建模方法 排便和直肠和阴道支持不足在引起OD症状中的作用。

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.