PROCURE: Patient Reported Outcomes After Surgery for Deep Endometriosis Infiltrating the Muscular Layer of the Rectum: a Prospective Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 294
- 试验地点
- 3
- 主要终点
- The proportion of patients experiencing one of the following symptoms at 12 months postoperatively:
研究概览
简要总结
To describe the difference in patient reported outcomes after conservative treatment in comparison to radical rectal surgery in patients with deep endometriosis infiltrating the rectum (up to 15cm from the anus with at least involvement of the muscularis layer) and to determine predictors for radical surgery.
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 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Age: 18 - 45 years (both inclusive)
- •Complaining of infertility and/or pain
- •Deep endometriosis infiltrating the rectum on at least one imaging technique up to 15 cm from the anus and involving at least the muscularis layer in depth
排除标准
- •Refusal of bowel resection/stoma
- •History of laparotomy for endometriosis
- •(history of) Hysterectomy
- •Suspected pelvic malignancy
- •Pregnancy
- •Impossibility for postoperative follow-up in our hospital
研究组 & 干预措施
Conservative surgery
干预措施: PROMS (Other)
Radical surgery (segmental resection)
干预措施: PROMS (Other)
结局指标
主要结局
The proportion of patients experiencing one of the following symptoms at 12 months postoperatively:
时间窗: 12 months postoperatively
* constipation (1 stool/\>5 consecutive days) * frequent bowel movement (≥3 stools/day) * defecation pain * anal incontinence (involuntary loss of gas or stools) * dysuria * bladder atony requiring self-catheterization
The determination of possible risk factors for radical surgery.
时间窗: 3 months postoperatively
based on patient complaints, preoperative imaging techniques and intra operative finding
次要结局
未报告次要终点