Analysis of Surgical Outcomes in Women Undergoing Mesenteric Vascular and Nerve Sparing Surgery in Laparoscopic Segmental Colorectal Resection for Deep Infiltrating Endometriosis
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 50
- 主要终点
- Change in endometriosis related dyschezia evaluated by Numeric Rating Scale for Pain
研究概览
简要总结
Colorectal resection is a standard surgical treatment of bowel deep infiltrating endometriosis (DIE). Nevertheless, concerns about different bowel functional outcomes related to radical surgery versus conservative surgery as shaving technique is a topic leading to much debate. Different surgical approach are used to perform colorectal resection and there is not a standardized technique. For the same concerns, studies have addressed the mesenteric vascular and nerve preservation both in oncological and benign intestinal disease with improved functional outcome. Therefore, the aim of this prospective study is to analyze feasibility and safety of mesenteric vascular and nerve Sparing Surgery in laparoscopic segmental colorectal resection for DIE with short and long term follow up. Women with DIE ,that underwent laparoscopic segmental colorectal resection, will undergo resection performed with inferior mesenteric artery and branching arteries preservation by dissecting adherent to the intestinal wall with mesenteric vascularization and innervation entirely preserved. Personal history, clinical data, surgical data, short and long term surgical complications and long term outcomes will be recorded. Symptoms and bowel function will be evaluated before and after 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
- 20 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Patients referred for bowel endometriosis requiring colorectal resection
排除标准
- 未提供
结局指标
主要结局
Change in endometriosis related dyschezia evaluated by Numeric Rating Scale for Pain
时间窗: Change from baseline dyschezia at 60 days after surgery and at 1 year after surgery
Dyschezia in 0 - 10 range according to the Numeric Rating Scale for Pain
Change in endometriosis related dysuria evaluated by Numeric Rating Scale for Pain
时间窗: Change from baseline dysuria at 60 days after surgery and at 1 year after surgery
Dysuria in 0 - 10 range according to the Numeric Rating Scale for Pain.
Change in bowel symptoms evaluated by Constipation Assessment Scale
时间窗: Change from baseline bowel symptoms at 60 days after surgery and at 2 year after surgery
Bowel symptoms in 0 - 16 range according to the Constipation Assessment Scale. Constipation Assessment Scale includes eight items, each of which is self-rated by the patient as 'no problem' (score of 0), 'some problem' (score of 1), or 'severe problem' (score of 2). The item ratings are then summed, so the overall score may range from 0 (no constipation) to 16 (worst possible constipation).
Change in endometriosis related dysmenorrhea evaluated by Numeric Rating Scale for Pain
时间窗: Change from baseline dysmenorrhea at 60 days after surgery and at 1 year after surgery
Dysmenorrhea in 0 - 10 range according to the Numeric Rating Scale for Pain
Change in endometriosis related dyspareunia evaluated by Numeric Rating Scale for Pain
时间窗: Change from baseline dyspareunia at 60 days after surgery and at 1 year after surgery
Dyspareunia in 0 - 10 range according to the Numeric Rating Scale for Pain.
Change in endometriosis related pelvic chronic pain evaluated by Numeric Rating Scale for Pain
时间窗: Change from baseline pelvic chronic pain at 60 days after surgery and at 1 year after surgery
Pelvic chronic pain in 0 - 10 range according to the Numeric Rating Scale for Pain.
次要结局
- Endometriosis characteristics(intraoperative)
- Complication rate(Within 6 months after surgery)
研究者
Antonio Simone Laganà
Medical Doctor
Università degli Studi dell'Insubria