LARC Study: Three-dimensional Versus Conventional 2D-laparoscopy for Rectocele and Rectal Prolapse Repair: a Prospective, Randomized, Single Center Study.
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- objective cure rate
研究概览
简要总结
The aim is to compare proximate and remote results of 3D and conventional 2D laparoscopic interventions in terms of efficacy and safety in treatment of symptomatic rectocele and rectal prolapse.
This is a prospective randomized comparative study in parallel groups conducted in single Colorectal unit. Inclusion criteria: female patients with stage 3 rectocele (3-4 POP-Q [pelvic organ prolapse quantification] grade) and/or full-thickness rectal prolapse.
Intervention - laparoscopic ventral rectopexy. The primary outcome is objective cure rate of pelvic prolapse. Secondary outcomes include obstructive defecation and incontinence symptoms according to Wexner and Cleveland Clinic scales, and satisfaction according to Patient Global Impression of Improvement questionnaire. Operative times, intraoperative blood loss, length of hospital stay, postop pain severity, urinary incontinence, as well as surgical and mesh complications are also assessed.
The specific point of interest in this study is surgeon's tiredness after the operation assessed with Profile of Mood States questionnaire.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
盲法说明
Outcomes are assessed by 2 independent blinded coloproctologists
入排标准
- 年龄范围
- 18 Years 至 70 Years(Adult, Older Adult)
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •stage 3 rectocele (3-4 POP-Q grade) and/or full-thickness rectal prolapse
- •age 18-70 y.o.
排除标准
- •severe concomitants chronic diseases (American Society of Anesthesiologists class III - IV),
- •ongoing oncological diseases,
- •ongoing hematological diseases,
- •ongoing inflammatory diseases of the colon and pelvic organs,
- •pregnancy
结局指标
主要结局
objective cure rate
时间窗: 12 months postop
objective cure rate according to clinical POP-Q assesment
次要结局
- incontinence cure(12 months postop)
- patient's satisfaction(12 months postop)
- obstructive defecation cure(12 months postop)
研究者
Alexander Khitaryan
Professor
Private Healthcare Institution Clinical Hospital RGD-Medicine
