A Single Blind, Randomized, Controlled Study to Evaluate the Safety and Effectiveness of EVICEL® as an Adjunct to Gastrointestinal Anastomosis Techniques
- Conditions
- Diseases of the digestive system
- Registration Number
- KCT0000490
- Lead Sponsor
- Johnson & Johnson Medical Korea
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot yet recruiting
- Sex
- All
- Target Recruitment
- 28
Preoperative:
1) Subjects undergoing primary elective lower anterior resection with a stapled end-toend
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:
1) Confirmed distance of anastomosis is =12cm from the anal verge, as measured using
a rigid rectoscope.
2) Anastomosis with a successful leak test.
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 for the 90 day follow up period after surgery.
Intraoperative:
1) Subject requiring protective ostomy;
2) Subjects with any intra-operative findings identified by the surgeon that may preclude conduct of the study procedures.
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Absence of clinical anastomotic leak
- Secondary Outcome Measures
Name Time Method Incidence of clinical anastomotic leak/ Incidence of stricture