A study of the safety and effectiveness of EVICEL® as a treatment in addition to standard techniques of joining the colon together
- Conditions
- Gastrointestinal Anastomosis LeakTherapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Surgical Procedures, Operative [E04]
- Registration Number
- EUCTR2011-005479-17-GB
- Lead Sponsor
- Ethicon Inc., a Johnson & Johnson Co.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- Target Recruitment
- 214
Preoperative:
1) Subjects undergoing primary elective lower anterior resection with a stapled end-to-end or end-to-side anastomosis;
2) Subjects = 18 years of age who are willing to participate in the study and provide written informed consent prior to any study-related procedures;
Intraoperative:
3) Confirmed distance of anastomosis is =12cm from the anal verge, as measured using a rigid scope or non-flexible scope alternative.
4) Anastomosis with a successful leak test.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 75
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 75
Preoperative:
1)Avastin use within 30 days prior to surgery;
2)Known hypersensitivity to the human blood products or the components of the investigational product;
3)Female subjects who are pregnant or nursing;
4)Exposure to another investigational drug or device in a clinical trial within 30 days prior to surgery or planned/intended for the 90 day follow up period after surgery.
Intraoperative:
5)Subject requiring protective ostomy;
6)Subjects with any intra-operative findings identified by the surgeon that may preclude conduct of the study procedures.
7)Use of any fibrin sealant for hemostasis during the surgical procedure.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method