Preservation of Inferior Mesenteric Artery Could Improve Sexual Function After Laparoscopic Colorectal Resection for Diverticular Disease
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 300
- 试验地点
- 2
- 主要终点
- Sexual disfunction 1
研究概览
简要总结
This study aims to evaluate whether IMA sparing may represent an advantage in terms of reduced incidence and severity of sexual dysfunctions after colorectal resections for diverticular disease (DD).
详细描述
Enrolled patients were randomly divided into 2 treatment groups. In the first group (IMAP) the IMA was preserved sectioning the sigmoid arteries near colonic wall while, in the second group (IMAS) the IMA was sectioned immediately below the origin of the left colic artery. Incidence and severity of sexual dysfunction and QoL were assessed by four validated questionnaire administered 6,12 months and 5 and 8 years after surgery.
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, Investigator)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •diverticular disease
- •Diverticulitis
- •BMI under 35 Kg/mq
- •ASA score from I to III
- •Standardized sigmoid, left colon or rectal resection
排除标准
- •complicated diverticulitis (Hinchey III-IV)
- •previous abdominal surgery or prostatic and/or gynecological resections
- •adverse local condition or the need of multiorgan resection or stoma creation
结局指标
主要结局
Sexual disfunction 1
时间窗: 12 months after surgery
Presence of sexual disfunction ( defined through the evaluation of sexual desire ,arousal, lubrication , orgasmic function, overall satisfaction, pain, intercourse satisfaction , erectile function)
Sexual disfunction 2
时间窗: 6 years after surgery
Presence of sexual disfunction ( defined through the evaluation of sexual desire ,arousal, lubrication , orgasmic function, overall satisfaction, pain, intercourse satisfaction , erectile function)
次要结局
- Quality of life SF-36 1(12 months after surgery)
- Sexual Function Male 1(12 month after surgery)
- Sexual Function Female 1(12 months after surgery)
- Quality of Life 1(12 months after surgery)
- Quality of Life 2(6 years after surgery)
- Quality of life SF-36 2(6 years after surgery)
- Sexual Function Male 2(6 years after surgery)
- Sexual Function Female 2(6 years after surgery)
研究者
Francesco Saverio Mari, MD, PhD, FACS
Researcher
University of Roma La Sapienza