Extensive Abdominal Lavage Following Laparoscopic Full Thickness Resection of Deep Endometriosis Involving the Bowel, Effects on Post-Operative Inflammation: a Randomised Controlled Trial
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- KU Leuven
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Post-operative C-reactive protein blood values
研究概览
简要总结
Surgical treatment of deep endometriosis with bowel involvement is widely accepted to require complete excision of all endometriosis also when invading the bowel. In case of opening of the bowel a subsequent inflammatory reaction follows the surgery, as demonstrated by the increase in blood levels of C-reactive protein during the first post-operative week. Furthermore it increases the risk of post-operative bowel complications. In case of peritonitis the general surgeons use extensive lavage in order to decreases mortality, morbidity and post-operative adhesions formation, as demonstrated in animal models and clinically in patients with peritonitis. Considering the efficacy of extensive lavage for peritonitis and the inflammatory reaction as judged by the increased C-reactive protein (CRP) following full thickness deep endometriosis resection from the bowel, the study aims to evaluate, in women undergoing this procedure, the effect of extensive abdominal lavage on abdominal inflammation and post-operative bowel complications.
详细描述
In a consecutive series 20 women with full thickness resection for deep endometriosis received randomly, at the end of the procedure, a standard abdominal rinsing (n=10) or extensive abdominal lavage with 8 Liters of saline (n=10). C-reactive protein and white blood cell count values were collected daily for 7 days. Women were observed for complications during the first post-operative week and during the follow up at 1 and 6 months.
The primary end point was to evaluate the effects of extensive abdominal lavage on post-operative inflammation. Secondary end-point was to explore the potential protective rule against post-operative bowel complications.
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 50 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •The patients (aged 18-50 years) were all recruited from a single, tertiary referral hospital at Leuven University, Belgium, specializing in the surgical treatment of severe endometriosis.
- •All the women were scheduled for a surgical excision of a rectovaginal nodule.
- •Women with a full thickness involvement of the bowel requiring discoid resection were included.
排除标准
- •evidence on chest x-ray in the previous 3 months of old or currently active TB, even if adequately treated;
- •evidence of serious infections (such as pneumonia or pyelonephritis) in the previous 3 months
- •evidence of a documented HIV infection, active hepatitis-B or C, or an opportunistic infection (e.g. herpes zoster, cytomegalovirus, pneumocystis carinii, aspergillosis, histoplasmosis, or mycobacteria other than TB) in the previous 6 months
- •Previous transplant surgery, a lymphoproliferative disorder or other malignancy
- •Positive cervical cytology in the previous 6 months
- •Any haematological or biochemical abnormalities on routine screening.
结局指标
主要结局
Post-operative C-reactive protein blood values
时间窗: Daily for 1 week
次要结局
- Bowel complications rate(By the clinicians during the first post-operative week and at 1 and 6 months)