Study to Evaluate the Efficacy and Safety of Anti-Adhesion Product in the Prevention of Intraperitoneal Adhesions
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 46
- 试验地点
- 14
- 主要终点
- Incidence of adhesions around the rectal stump and/or incision line
研究概览
简要总结
The objective of this study was to evaluate the efficacy of the Anti-Adhesion Product (AAP) in preventing or reducing post-operative adhesion formation and re-formation in a subject population having abdominal surgery and being left with a rectal stump and a temporary stoma from a first procedure and scheduled for a laparoscopy/ laparotomy as a second procedure in the normal treatment of the subjects' disease. In both study groups, surgical measures to prevent adhesions were taken, e.g. using minimum traumatizing surgical technique, using powder-free gloves. In the investigational product group, AAP was applied to the rectal stump and the incision line while no specific additional treatment was applied in the control group. The surgeon assessed preexisting adhesions during the first surgery. Newly developed and re-formed adhesions were evaluated during the second surgery by a surgeon or assistant who did not know the result of randomization. The safety of the study drug was also monitored.
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Written informed consent obtained from the subject or the subject's legally authorized representative prior to study entry
- •Male or female subjects > 18 years of age
- •Subjects undergoing abdominal surgery with the possibility that a rectal stump would remain due to one or more of the following reasons: inflammatory bowel diseases, neoplasm, colon diverticulitis, colonic obstruction, colon polyposis, peritoneal trauma, fistula, incontinence, or other reasons
- •Subjects for whom a second abdominal surgery is planned within approximately eight months of the first surgical procedure.
排除标准
- •Pre operative:
- •Pregnancy and lactation period
- •Subjects concurrently participating in another clinical trial with a drug or a device
- •Subjects who have participated in a clinical trial with a drug or a device within 30 days prior to this study
- •Subjects who have had abdominal/pelvic surgery within six months prior to this study
- •Subjects who have received or will receive (approximately within the next eight months) abdominal/pelvic irradiation
- •Intra operative:
- •Subjects with peritonitis
- •Subjects with gastrointestinal metastatic cancer, or cancer growing per continuitatem into surrounding tissues
- •Subjects treated with hemostatic agents (e.g. fibrin sealant, collagen, oxidized cellulose) during the first surgery
- •Subjects treated with adhesion prevention agents other than the Anti-Adhesion Product (AAP) (e.g. Intergel® Adhesion Prevention Solution, Seprafilm® Membrane) during the first surgery
- •Subjects with major fecal contamination needing an abdominal lavage during the first surgery
研究组 & 干预措施
Investigational product group
Anti-Adhesion Product was applied to the rectal stump and the incision line.
Like in the control group, surgical measures to prevent adhesions were also taken, e.g. using minimum traumatizing surgical technique, using powder-free gloves.
干预措施: Anti-Adhesion Product (Biological)
Control group
Only surgical measures to prevent adhesions were taken, e.g. using minimum traumatizing surgical technique, using powder-free gloves. No specific additional treatment was applied.
结局指标
主要结局
Incidence of adhesions around the rectal stump and/or incision line
次要结局
- Extent and severity of adhesions around the rectal stump
- Extent and severity of adhesions at the incision line
- Number of subjects with no adhesions
- Incidence, extent and severity of adhesions at sites other than the rectal stump and incision line
- Time to reach and free the rectal stump
- Safety (laboratory evaluation, recording of adverse experiences)