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临床试验/NCT03779256
NCT03779256已完成不适用

ENDO - Bowel ENDOmetriosis; Evaluation of Diagnostics and Quality of Life (ENDO1, ENDO2, ENDO3)

Oslo University Hospital3 个研究点 分布在 3 个国家目标入组 207 人开始时间: 2018年12月10日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
207
试验地点
3
主要终点
ENDO3: Measurements of bowel lesion size with MRI compared to 2D TVS and surgery

研究概览

简要总结

Endometriosis on the bowel is a benign condition that can cause major complaints and severely affect the quality of life of women of fertile age. If medical treatment is not enough to improve pain and/or other symptoms it may be necessary to undergo major surgical treatment and removal of the endometriosis nodule on the bowel. Such extensive surgical treatment carries risks of serious complications. Therefore, a thorough diagnostic work-up before surgery is important to know the extent of disease. This will provide women with the best possible information and for the surgeon to plan the operation. The risk of complications increases as the bowel endometriosis is localized closer to the anus as well and/or if the bowel nodule is large.

The distance between the anus and the nodule and the size of the nodule can be measured with two dimensional (2D) vaginal ultrasound. Additionally, Magnetic resonance imaging (MRI) is also used in some countries for these same measurements. Our study would like to investigate the diagnostic value of 2D ultrasound and MRI as well as learn more about women's quality of life before and after surgery. The investigators have designed the study to evaluate the following three questions into three studies ENDO1, ENDO2 and ENDO3:

  • ENDO1: How good is 2D transvaginal ultrasound at measuring the size of the bowel endometriosis nodule and the distance between anus and the lower part of the bowel nodule compared to measurements done during surgery?
  • ENDO2: What is the quality of life, sexual and bowel function of women before and 3- and 12-months after surgery due to bowel endometriosis? Questionnaires will be used.
  • ENDO3: How good is 2D transvaginal ultrasound at measuring the size of the bowel endometriosis nodule compared to magnetic resonance imaging (MRI) and measurements done during surgery?

详细描述

Mild endometriosis normally affects the peritoneum. More advanced form of endometriosis is termed deep infiltrating endometriosis (DIE). In women suffering from DIE, the endometriotic tissue invades the tissue >5mm below the peritoneal surface, affecting organs in the pelvis like the ovaries, uterus, vagina, bladder, ureters and/or bowel. In women with suspected endometriosis, the prevalence of DIE affecting the bowel is found to range from 24.0 to 73.3%. The symptoms of DIE can be debilitating with dysmenorrhoea, dyspareunia, altered bowel motions, dyschezia and/or dysuria. Thus, it may have an immense impact on women's quality of life with societal consequences.

The risk of complications with surgery for deep infiltrating endometriosis (DIE) of the bowel can be severe like anastomotic leak and rectovaginal fistula. Evidence show that there is an increased risk of anastomotic leaks bowel if the anastomosis <5-8cm from the anal verge. DIE of the rectosigmoid colon can be diagnosed by widely available and low-cost two-dimensional transvaginal sonograhpy (2D-TVS) with a high sensitivity and specificity. MRI is comparable to TVS in diagnosis of intestinal endometriosis but is costlier and less available than TVS. MRI has the advantage over 2D-TVS that it is reproducible, the area of interest can be viewed in many planes and the images can be reviewed and compared by same or different examiners over time.

There are two surgical approaches used in women suffering from bowel endometriosis, namely segmental resection of rectosigmoid or nodule excision. Nodule excision may be performed by shaving (not opening the rectum) or disc excision (removing bowel nodule with surrounding rectal wall). The success of pelvic pain reduction following surgery in women suffering from DIE is related to the radicality of surgery. However, some argue a more symptom-guided approach to surgery.

Endometriosis itself and surgical treatment may have immense impact endometriosis can have on a woman's life. Thus, it is essential to discuss the severity of symptoms, any implications of surgery as well as the risk of complications to enable women informed consent. The pre-operative information and decision making is based on symptoms, fertility wish, the clinical examination and diagnostic tests. Consequently, diagnostic tools such as TVS and MRI are important factors to plan and perform a safe procedure with the best possible outcomes for the women.

There are, to the investigator's knowledge, no studies, which demonstrate if there is a correlation between measurement of the size of an endometriotic rectosigmoid lesion with 2D-TVS compared to the actual lesion size in the resected bowel. Additionally, there are no studies that investigate the correlation between the distance between the rectosigmoid lesion and the anal verge, to plan appropriate surgery and estimate risk of serious complications. Furthermore, there are no known studies evaluating the correlation of measurements of bowel lesions when comparing transvaginal 2D-TVS, MRI and surgery. The aim of surgery is to improve women's quality of life and thus it is essential to evaluate results before and after surgery for bowel endometriosis.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 50 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Women of reproductive age, ≥ 18 years old, scheduled for planned laparoscopic or open bowel surgery for deep infiltrating endometriosis with suspected symptomatic bowel lesions.

排除标准

  • Postmenopausal women, women < 18 years old, women with previous bowel surgery. Women who do not speak and read fluent English or Norwegian.

结局指标

主要结局

ENDO3: Measurements of bowel lesion size with MRI compared to 2D TVS and surgery

时间窗: Before and during scheduled surgery

Millimeter measurements of the bowel lesion in three orthogonal planes i.e. mid-sagittal, anteroposterior and transverse according to the IDEA group.

ENDO1AMeasurements on the distance between the lower margin of the rectal lesion and anal verge with 2D-TVS

时间窗: Before scheduled surgery

Millimeter distance measured on 2D TVS

ENDO1A: Measurements on the distance between the lower margin of the rectal lesion and anal verge

时间窗: During scheduled surgery

Millimeter distance measured during surgery

ENDO1B: Size of bowel lesion measured with 2D-TVS.

时间窗: Before scheduled surgery.

Millimeter measurements of the bowel lesion in three orthogonal planes i.e. mid-sagittal, anteroposterior and transverse according to the IDEA group.

ENDO3: Correlation between Lesion to anal verge distance (LAVD) measured with 2D-TVS, MRI and measurements during surgery

时间窗: Pre-operatively and during surgery

Millimeters of lesion to anal verge distance measured

ENDO2: Incidence of low anterior resection syndrome (LARS)

时间窗: Preoperatively, 3- and 12-months postoperatively

LARS questionnaire consisting of five questions, each response correlates to a score. Lowest score is 0-20 i.e. no LARS, score 21-29 i.e. minor LARS and score 30-42 i.e. major LARS.

ENDO1B: Size of bowel lesion measured on the excised bowel lesion.

时间窗: During surgery.

Millimeter measurements of the bowel lesion in three orthogonal planes i.e. mid-sagittal, anteroposterior and transverse according to the IDEA group.

次要结局

  • ENDO2: Quality of life Endometriosis Health Profile-30(Preoperatively, 3 and 12 months postoperatively)
  • ENDO2: Quality of life after bowel surgery(12 months)
  • ENDO1: Type and frequency of complications after bowel surgery(Through study completion, an average of 1 year)
  • ENDO1: Numerical analogue scale (NAS) score of dysmenorrhea, dyspareunia, dyschezia, dysuria.(Preoperatively, 3 and 12 months postoperatively)
  • ENDO2: Sexual function(Preoperatively, 3 and 12 months postoperatively)
  • ENDO2: Quality of life before bowel surgery(Before surgery)

研究者

发起方
Oslo University Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Kristine Aas-Eng

Principal investigator

Oslo University Hospital

研究点 (3)

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