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.

障碍物（OD）被定义为粪便的排空不完整，很普遍 妇女健康的疾病，导致重大质量（QOL）和医疗保健负担。 从历史上看，成功的管理因与两者的缺陷而受到损害 诊断和治疗。首先，存在一个持续的误解 缺乏异性痛（即骨盆底的不协调收缩）是由于脱垂而导致的 阴道后壁（“直肠”）修复后改善。实际上，先前的研究有 确认这种形式的OD是由于涉及直肠的支持缺陷而不是 阴道（8-10），此外，直肠修理在缓解OD症状方面是不可靠的。 我们中心的最新工作证实了直肠脱离和超级运动是主要的 OD的决定因素在直肠内的存在下。其次，传统 作为OD的来源，驴子支持的诊断方式很昂贵（例如MRI 缺陷）和/或侵入性（例如肛门测量法），通常会产生不清楚的发现 临床相关性和对护理的影响。最后，可修复直肠支撑的可用手术 缺陷仅限于侵入性的腹部或会阴方法，通常涉及 网状植入并保留用于严重病例，例如那些明显的直肠脱垂的人。 腹腔镜或开放式腹侧网状直肌是稳定最广泛的操作 直肠支持。 我们正在检验以下假设：在缺乏异性恋的情况下，OD症状 直肠支持的缺陷以及与OR呈现OD符号的患者有关 如果没有阴道脱垂进行我们的新诊断评估和手术治疗 相对于手术后2年的当前护理标准的预后改善。我们的 研究旨在评估与两个直肠有关的主要和次要结果 在两个机构中，OD的2年跟进程序。该临床数据将是 通过计算建模方法完成，旨在提供最深入的见解 可能是OD符号的贡献者，即阴道和直肠支撑缺陷。目标1：比较 使用后隔室动态超声成像测量的神秘直肠直肠过敏性 与先生的缺陷学。后室动态超声是一种新颖的方法 确定患有OD症状的妇女的OD的根本解剖原因 并存功能性肠病（例如正常的BM频率和粪便类型，并且没有 Dyssynergia）。目标2：比较解剖，功能和与健康相关的生活质量结果 在具有中度至重度OD符号的女性受试者中，直肠超直运动诊断 超声检查，他们被随机分配到微创的经阴道直肠与腹部 手术后2年时腹侧直肌。目标3：开发和验证计算饰面 元素模型和统计形状建模方法来描述正常机制 排便以及直肠和阴道支持缺陷在引起OD症状中的作用。