The Impact of NOSE-colectomy on Fertility and Quality of Life Among Patients With Colorectal Endometriosis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 150
- 试验地点
- 2
- 主要终点
- Endometriosis Health Profile, EHP 30
研究概览
简要总结
Deep infiltrating endometriosis (DIE) represents the most severe form of endometriosis and is present in 20-35% of all women suffering from the disease. Intestinal nodules are observed in 3% to 37% of endometriosis patients. In cases of colorectal DIE, adequate therapy depends on the depth of infiltration and the size of the lesion as well as the woman's quality of life. Removal of the specimen after segmental bowel resection can be performed by either mini-laparotomy or by the natural orifice specimen extraction (NOSE) technique .
The assessment of the quality of life and fertility outcome of the patients was done by using electronic questionnaires before and after surgery.
详细描述
Endometriosis is an enigmatic disease affecting 6-10% of women of reproductive age or 176 millions of women worldwide (1). Endometriosis is defined as the presence of endometrial-like tissue outside the uterus and it induces a chronic inflammatory reaction (2). Deep infiltrating endometriosis (DIE) represents the most severe form of endometriosis (described by the invasion of anatomical structures and organs deeper than 5 mm beyond the peritoneum) and is present in 20-35% of all women suffering from the disease (3). Intestinal deep infiltrating endometriosis is known as lesions infiltrating at least the muscular layer of the bowel wall and most commonly affects the rectum, sigmoid colon and the rectovaginal septum. (4).
Even if bowel endometriosis may be totally asymptomatic, in many patients intestinal wall DIE alters significantly quality of life by provoking constipation, diarrhea, hematochezia, intestinal cramping, abdominal bloating, intestinal stenosis or obstruction and pain of defecation (5, 6). Rectal fixation to adjacent structures results in angulation of the rectum and subsequent defecatory pain and constipation. Fibrosis of nodules can lead to rectal constriction and stenosis, cyclical inflammation of the rectal wall may lead to changes in bowel habit (usually diarrhoea) with or without rectal bleeding (7).
Although the surgical laparoscopic management of endometriosis is widely accepted, the optimal type of resection, whether conservative approach (shaving, disc resection) or radical technique (involves limited resection of the bowel wall with preservation of all adjacent structures-autonomic pelvic plexus, rectal vascular supply- known as "nerve-vessel sparing limited segmental resection"), is under discussion for treatment of deep endometriosis infiltrating the rectum.
In cases of colorectal DIE, adequate therapy depends on the precise location, extent of the nodule and depth of invasion, as well as the woman's quality of life (3). Removal of the specimen after segmental bowel resection can be performed by either mini-laparotomy (conventional method) or by the natural orifice specimen extraction (NOSE) technique. (8).
The conventional method raises concerns because this could disrupt the integrity of the abdominal wall. Moreover, extraction site laparotomy is associated with higher postoperative pain scores. The occurrence of particular complications such as incisional hernias and wound infections is also higher than after conventional laparoscopic procedures (8).
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
- None
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Endometriosis Health Profile, EHP 30
时间窗: 24 months
To describe the difference in patient reported outcomes after conventional segmental bowel resection treatment in comparison to NOSE colectomy in patients with deep endometriosis infiltrating the rectum. The patients are asked to fill the questionnaires preoperatively, at 30 days, 6 months, 1 year and 2 years after the surgery. During the present study investigators are planning an average follow-up of 24 months. Impact of surgical technique on the quality of life. The outcome will be assessed using validated electronic questionnaires containing questions from Endometriosis Health Profile 30. This is a core questionnaire which consists of five scales (pain, control and powerlessness, emotional well-being, social support, and self-image) contains a total of 30 items. (10)
Gastrointestinal Quality of Life Index, GIQLI
时间窗: 24 months
To describe the difference in patient reported outcomes after conventional segmental bowel resection treatment in comparison to NOSE colectomy in patients with deep endometriosis infiltrating the rectum. The patients are asked to fill the questionnaires preoperatively, at 30 days, 6 months, 1 year and 2 years after the surgery. During the present study investigators are planning an average follow-up of 24 months. GIQLI is a 36-item patient reported outcomes instrument designed to assess GI-specific health-related quality of life in clinical practice of patients with gastrointestinal disorders. It has five domains (GI symptoms, emotion, physical function, social function and medical treatment) and subscores range from 0-4 while the total score range from 0-144. Higher scores mean better GI health-related quality of life. (11)
Infertility outcomes after colorectal resection for bowel endometriosis
时间窗: 24 months
Number of pregnancies, cumulative pregnancy rate and take home baby rate after laparoscopic bowel resection.
Psychological questionnaires:
时间窗: 24 months
To describe the difference in patient reported outcomes after conventional segmental bowel resection treatment in comparison to NOSE colectomy in patients with deep endometriosis infiltrating the rectum. The patients are asked to fill the questionnaires preoperatively, at 30 days, 6 months, 1 year and 2 years after the surgery. During the present study investigators are planning an average follow-up of 24 months. Pain catastrophizing Scale, Self-Efficacy for Managing Chronic Disease 6-item Scale to investigate the psychological aspect of the disease (14,15).
Endometriosis related pain before and after colorectal resection for DIE
时间窗: 24 months
To describe the difference in patient reported outcomes after conventional segmental bowel resection treatment in comparison to NOSE colectomy in patients with deep endometriosis infiltrating the rectum. The patients are asked to fill the questionnaires preoperatively, at 30 days, 6 months, 1 year and 2 years after the surgery. During the present study investigators are planning an average follow-up of 24 months. For the assessment of pre- and postoperative pain a Visual Analogue Scale is used (from 1-10, where 1 is the lowest and 10 is the maximum score) to assess the pre- and postoperative quality of life (dysmenorrhoea, dyspareunia, dyschezia, dysuria, CPP) (13).
LARS score before and after colorectal resection for DIE
时间窗: 24 months
To describe the difference in patient reported outcomes after conventional segmental bowel resection treatment in comparison to NOSE colectomy in patients with deep endometriosis infiltrating the rectum. The patients are asked to fill the questionnaires preoperatively, at 30 days, 6 months, 1 year and 2 years after the surgery. During the present study investigators are planning an average follow-up of 24 months. The Low Anterior Resection Syndrome (LARS) is a common complication that occures after colorectal surgery. The LARS score is a simple self-administered questionnaire measuring bowel dysfunction after rectal surgery. Contains questions regarding incontinence, emptying difficulties, urgency, and frequency. The calculated score ranges from 0 to 42, with a score of 0-20 representing no LARS, a score of 21-29 representing minor LARS and a score of 30-42 representing major LARS. (12)
次要结局
- Hospital stay after colorectal resection perfomed for the treatment of bowel endometriosis(24 months)
- Lenght of recovery after colorectal resection performed for the treatment of bowel endometriosis(24 months)
- Complication rates after conventional and NOSE-colectomy performed for colorectal endometriosis(24 months)