跳至主要内容
临床试验/NCT03245086
NCT03245086Unknown不适用

Multi-center, Non-randomized Prospective Observation Study Comparing Ferguson Hemorrhoidectomy and Transanal Hemorrhoidal Dearterialization (THD) for Prolapsed, Nonincarcerated, Reducible Hemorrhoids in Terms of 1-year Recurrence

Stony Brook University1 个研究点 分布在 1 个国家目标入组 492 人开始时间: 2016年8月17日最近更新:
适应症

试验速览

阶段
不适用
入组人数
492
试验地点
1
主要终点
1-year recurrence rates

研究概览

简要总结

This study will compare Ferguson hemorrhoidectomy and THD in terms of one-year recurrence in a large population (N=492). Recurrence is defined as prolapsing internal hemorrhoids at physical examination performed by a colorectal surgeon.

详细描述

This is a multicenter, parallel arm, non-randomized prospective data collection trial comparing Ferguson hemorrhoidectomy and THD in terms of recurrence rates at one-year. All subjects will already be scheduled for either Ferguson or THD hemorrhoidectomy, the surgery is NOT part of the research. Although a randomized study would control for variation among surgeons, this study design provides the best patient safety since the surgeons will perform the technique they do most frequently. Variability in the patient population will be managed with a conservative sample size, which allows for a multivariate analysis of the sample populations if any confounding variables are noted during initial data analyses. In addition, the variability will be minimized with stringent and detailed inclusion/exclusion criteria in terms of hemorrhoidal disease. Patients will be enrolled and followed for one year. Participating surgeons will be credentialed and each participating surgeon will enroll up to ten consecutive patients.

The primary endpoint of this study is to compare Ferguson hemorrhoidectomy and THD in terms of recurrence rates at one-year. Recurrence is defined as prolapsing internal hemorrhoids at physical examination performed by a colorectal surgeon.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patient must be:
  • At least 18 years-old
  • Able to sign informed consent
  • Presenting with prolapsed, non-incarcerated, reducible hemorrhoids in at least 3 columns at physical examination and scheduled for either Ferguson or THD hemorrhoidectomy.

排除标准

  • Any prior anorectal surgery except for conventional office-based interventions (rubber band ligation, sclerotherapy, and infrared coagulation)
  • Prior pelvic radiotherapy
  • Inflammatory bowel diseases
  • Pre-existing fecal incontinence (Wexner score5 ≥8)
  • Pre-existing chronic anal diseases
  • Grades III and IV gynecological and obstetrical trauma per medical history and/or physical examination
  • Connective tissue disorders
  • Subject is pregnant
  • Subject is under incarceration

结局指标

主要结局

1-year recurrence rates

时间窗: 1-year

The primary endpoint of this study is to compare Ferguson hemorrhoidectomy and THD in terms of recurrence rates at one-year. Recurrence is defined as prolapsing internal hemorrhoids at physical examination performed by a colorectal surgeon.

次要结局

  • Postoperative complications(30 days)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

George Angelos

George Angelos, MD, MS

Stony Brook University

研究点 (1)

Loading locations...

相似试验