Efficacy and Safety of LifeSeal Kit for Staple Line Sealing in Colorectal and Coloanal Anastomoses: A Prospective Randomized Study

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