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临床试验/NCT04817150
NCT04817150Unknown不适用

LARC Study: Three-dimensional Versus Conventional 2D-laparoscopy for Rectocele and Rectal Prolapse Repair: a Prospective, Randomized, Single Center Study.

Alexander Khitaryan2 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2021年3月10日最近更新:
适应症

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

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

发起方
Alexander Khitaryan
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Alexander Khitaryan

Professor

Private Healthcare Institution Clinical Hospital RGD-Medicine

研究点 (2)

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