A Randomized, Controlled, Clinical Trial to Assess the Effect and Safety of the C-Qur™ fiLm, an antI-adhesive Barrier for the PrevEntion of sUrgical adhesionS
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- adhesions at the incision site
研究概览
简要总结
Adhesions develop in more than 90% of patients undergoing an intra-abdominal surgical leading to serious consequences and complications at reoperation.
The investigators initiate a prospective, randomized, controlled, multicenter trial to assess whether the use of C-Qur™ Film decreases the incidence of adhesion formation in subjects undergoing colorectal surgery. Treatment with the application of C-Qur™ Film as an adhesion prevention barrier for colorectal surgery will be compared with the control group at the second stage ostomy takedown procedure. The primary outcome evaluation will be assessment of adhesions to the incision site.
详细描述
Rationale:
Adhesions are fibrous bands that connect tissue surfaces where anatomical connections do not normally exist. Adhesion tenacity appears to be related to maturity, as they can be filmy or heavily vascularized with sensory nerve fibers. Adhesions are formed after a tissue surface has been injured (abrasion, desiccation, lysis, etc.) and the subsequent process of fibrinolysis is interrupted. Adhesions develop in more than 90% of patients undergoing an intra-abdominal surgical procedure. The clinically relevant symptoms of adhesion formation are small bowel obstruction, secondary infertility and pain. Other consequences and complications of postsurgical intra-abdominal adhesion formation include inadvertent enterotomy and increased dissection time due to adhesiolysis during repeat surgery. The C-Qur™ Film offers reduction of adhesion formation and the corresponding potential reductions in small bowel obstruction, secondary infertility, pain and incidence of enterotomies and prolonged dissection time during subsequent abdominal surgery.
Objective:
The primary objective is to assess whether the use of C-Qur™ Film decreases the incidence of adhesion formation in subjects undergoing colorectal surgery with a temporary loop ileostomy or loop/split colostomy. Treatment with the application of C-Qur™ Film as an adhesion prevention barrier for colorectal surgery will be compared with the control group at the second stage ostomy takedown procedure. The primary outcome evaluation will be assessment of adhesions to the incision site.
Safety objective is to assess the number and type of post-operative complications.
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
- Triple (Participant, Investigator, 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
- •Patients undergoing either open or hand assisted laparoscopic colonic and/or rectal resection whereby an incision is made of 6 cm or longer
- •Patients willing and capable of providing written informed consent prior to study enrolment
排除标准
- •Pregnant women
- •Patients for whom it is known, prior to the initial procedure, that loop ileostomy or colostomy closure between 8 and 16 weeks is not feasible for any reason
- •Patients with known/active intra-abdominal infection such as peritonitis, abdominal abscess, anastomotic leakage or fistula (Interloop abscesses in the resection specimen is not an exclusion criterion)
- •Patients with endometriosis
- •Patients with known allergies to any component of the C-Qur Film device
- •Patients requiring an additional procedure at the time of loop ileostomy or colostomy takedown deemed interfering with adhesion assessment by the treating surgeon.
- •Patients in whom it is intended to use intraoperative lavage/irrigation with any anti-adhesion solutions other than lactated ringers and/or saline (e.g. dextran, heparin, corticosteroids, ADEPT, any other irrigant that is believed to have anti-adhesion properties ) or an adhesion barrier other than C-Qur Film™.
- •Patients who have received within the last 30 days or are planned to receive systemic agents prior to the index procedure with the intention to prevent adhesion formation
- •Planned chemotherapy and/or abdominal radiotherapy between index surgery and loop ileostomy or colostomy takedown
- •Patients taking immune system suppressants deemed by the surgeon to interfere with wound healing (patients taking daily doses of corticosteroids exceeding 20mg within the prior 30 days are to be excluded). Patients requiring perioperative corticosteroid supplementation are not to be excluded.
- •Patients with impaired immune system function or coagulation disorders deemed by the surgeon to interfere with wound healing
- •Patients with a known history of severe multiple drug allergies
- •Patients who have a life expectancy of less than 6 months because of a medical condition or disease state
- •Any patient with a medical condition or other serious condition which will interfere with compliance and/or ability to complete this study protocol or who in the opinion of the investigator would not be a good candidate for enrolment
- •Patients participating in a study of another investigational device or drug
结局指标
主要结局
adhesions at the incision site
时间窗: 8-16 weeks after index surgery
The incidence of adhesions at the incision site
次要结局
未报告次要终点
研究者
Drs. M.W.J. Stommel
MD
University Medical Center Nijmegen