Endoluminal and Needlescopic Assisted Repair of Rectal Prolapse With Abdominal Fixation Under Sedation and Local Anesthesia
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 10
- 试验地点
- 2
- 主要终点
- rectal prolapse recurrence
研究概览
简要总结
The purpose of this study is to evaluate the safety and feasibility of endoluminal rectal prolapse repair under sedation and local anesthesia using CO2 colonoscopy to fix the rectum with sutures to the abdominal wall under needlescopic control. Further, investigators will evaluate the short and long-term clinical outcomes after this novel approach to treating rectal prolapse.
详细描述
.Aims/Objective The purpose of this study is to evaluate the safety and feasibility of endoluminal rectal prolapse repair under sedation and local anesthesia using CO2 colonoscopy to fix the rectum with sutures to the abdominal wall under needlescopic control. Further, we will evaluate the short and long-term clinical outcomes after this new procedure.
Primary Outcomes
- Feasibility: successful completion of endoluminal rectal prolapse repair with needlescopic assistance
- Safety: measured by the incidence of the Intraoperative complications (bowel perforation, organ injury and bleeding requiring blood transfusion)
- Sedation and local anesthesia feasibility: surgery completed without patient intubation
- Clinical Outcomes: rectal prolapse recurrence within 30 days, length of hospital stay and postsurgical complications
- Long Term Clinical Outcomes: Rectal Prolapse Recurrence
Methods Design: A prospective pilot study with 10 patients who will be undergoing Combined Needlescopic and Endoluminal (Colonoscopic) Surgery under sedation and local anesthesia for Rectal Prolapse Repair with the Colon and Rectal Surgeons at WCMC. Data will be collected prospectively before, during, and after surgery.
Settings: Colon and Rectal Surgery at WCMC-NYPH Population: Patients male and female above 75 years of age, with rectal prolapse will be invited to participate in the study after surgery is deemed necessary for standard treatment of their medical conditions.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 75 Years 至 100 Years(Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age, 75 years and older, Male and Female
- •BMI above 18 and ≤30
- •ASA class 1-3
- •willing to participate in the study
排除标准
- •ASA class 4-5
- •Previous Abdominal Surgeries including abdominal wall repair with mesh
结局指标
主要结局
rectal prolapse recurrence
时间窗: 12 months
次要结局
未报告次要终点
