Efficacy and Safety of LifeSeal Kit for Staple Line Sealing in Colorectal and Coloanal Anastomoses: A Prospective Randomized Study
Bruce Robb, MD
Primary Investigator
Overview
The primary objective of this study is to assess the efficacy and safety of LifeSeal? Kit as measured by the change in overall anastomotic leak rates in subjects undergoing low anterior resection with an anastomosis below 10 cm from the anal verge, over the first 17 weeks after surgery.
Description
The purpose of this study is to assess the efficacy and safety of LifeSeal Kit as measured by the change in overall anastomotic leak rates in subjects undergoing low anterior resection with an anastomosis below 10 cm for the anal verge, over the first 17 weeks after surgery.
Eligibility
You may be eligible for this study if you meet the following criteria:
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Conditions:
colorectal cancer
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Age: Between 21 Years - 100 Years
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Gender: All
Inclusion Criteria
Diagnosed with colorectal cancer
Scheduled for elective open, laparoscopic or robot assisted surgery involving the creation of a circular stapled anastomosis created within 10cm from the anal verge
Procedure involving Total Mesorectal Excision by an abdominal or transanal approach
Female subjects in child bearing age must be using acceptable contraception methods such as hormonal contraception or two forms of barrier contraception. Acceptable contraception must be used consistently from 30 days before screening until 3 years following surgery
Exclusion Criteria
Female who is pregnant, breastfeeding, or if of child bearing potential is unwilling to practice birth control until 3 years following surgery
Presence of a condition or abnormality that in the opinion of the Investigator would compromise the safety of the subject or the quality of the data
Has a history of hypersensitivity to porcine derived gelatin or collagen
Has a history of hypersensitivity to microbial Transglutaminase
Has a known dysfibrinogenemia, hypofibrinogenemia or a fibrinogenemia, without preoperative correction of fibrinogen levels
Participating in any other study involving an investigational (unapproved) drug or device within the past 60 days
Participating in studies involving approved drug or device will be enrolled only following a mutual consideration of the investigator together with the Sponsor
BMI ≥50, which may interfere with access to the surgical site and increase overall operative risk
Avastin use within 30 days prior to surgery
Has undergone a prior pelvic anastomosis
Scheduled for another surgery during the first 6 months following surgery (not including stoma closure ,placement of port for chemotherapy or ureter stent insertion)
Have an active abdominal or pelvic infection at the operation site
Has been previously treated with LifeSeal™ Surgical Sealant
Anastomosis or procedure (TME) was performed differently from what was defined in the inclusion criteria
Received intra-operative sealant, glue or any buttressing material other than the LifeSeal™ Surgical Sealant
Has peritoneal carcinomatosis
Requires additional unrelated anastomosis during the surgery
Going through another surgical procedure (other than ileostomy or adhesiolysis) during the surgery
Excessive bleeding (above 500cc) identified prior to anastomosis formation with the need for intra-operative blood transfusion