NCT00597662已完成1 期
Safety Study of Polylactide-Caprolactone-Trimethylenecarbonate Copolymer for Post-Operative Adhesion Prophylaxis
适应症
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Difference in visual analogue pain score on visit 8 after discharge minus visit 1 on admission
研究概览
简要总结
The purpose of this study is to compare adhesion prophylaxis with polylactide-caprolactone-trimethylenecarbonate copolymer to icodextrin 4% in terms of safety, side effects and usability in addition to gaining early evidence of the effectiveness of polylactide-caprolactone-trimethylenecarbonate copolymer.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •age 18-60 years
- •sex female
- •laparoscopic myomectomy indicated
- •ability and intention to conform to the study protocol
- •written informed consent
排除标准
- •pregnancy
- •indication for laparotomy
- •inflammatory bowel disease
- •additional surgical interventions
- •known or suspected intollerance or hypersensibility to the interventions
- •chronic pain
- •systemic corticoids or irradiation
- •alcohol abuse or other substance abuse
- •clinical signs of malignancy
- •psychiatric or neurological disease
- •participation in another clinical trial within 30 days
- •inability to understand the purpose of the trial or to conform to the study protocol
- •absence of written informed consent
- •inflammation of pelvic organs
- •presence of adhesions which lead to a conversion from laparoscopy to laparotomy
- •concurrent therapy with corticoids, anti-neoplastic agents or irradiation
- •maintenance therapy with non-steroidal anti-inflammatory drugs or analgesics
研究组 & 干预措施
1
Experimental
干预措施: polylactide-caprolactone-trimethylenecarbonate copolymer (Device)
2
Active Comparator
干预措施: Icodextrin 4% (Device)
结局指标
主要结局
Difference in visual analogue pain score on visit 8 after discharge minus visit 1 on admission
时间窗: 3 months
次要结局
- Usability as assessed by surgeon(Day 1)
- Use of analgesia(1, 2 and 3 days)
- Post-operative pyrexia(3 months)
- Post-operative infection(3 months)
- Requirement for re-operation(3 months)
- Dysmenorrhoea(3 months)
- Dyspareunia(3 months)
- Constipation(3 months)
- Diarrhoea(3 months)
- Nausea(3 months)
- Duration of adhesion prophylaxis(Day 1)
研究者
研究点 (1)
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