None listed
Conditions
Interventions
Drug : Standard of Care (Control Group):
Standard of Care (SoC) is a stapled end-to-end or end-to-side anastomosis without the use of a Fibrin Sealant or adjunctive treatment for sealing.
EVICEL® Fib
Sponsors
Johnson & Johnson Medical Korea
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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.
Exclusion criteria
Exclusion criteria: 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Absence of clinical anastomotic leak | — |
Secondary
| Measure | Time frame |
|---|---|
| Incidence of clinical anastomotic leak/ Incidence of stricture | — |
Countries
Korea, Republic of
Contacts
Public ContactIn Jeong
Asan Medical Center
Outcome results
None listed