anti-leakage sealing
Conditions
Interventions
For all subjects, standard hospital protocol will be followed for surgical
procedure and subject care management. This is except for a few interventional
procedures required for all patients per stu
coloanal anastomoses
colorectal anastomoses
medical device
staple line seal
Sponsors
LifeBond Ltd.
Eligibility
Age
18 Years to 64 Years
Inclusion criteria
Inclusion criteria: 1. Male or female * 21 years of age at Screening Visit. 2. Written informed consent obtained from subject or subject*s legal representative and ability for subject to comply with the requirements of the study. 3. Subject is diagnosed with colorectal cancer 4. Subject is scheduled for elective open, laparoscopic or robot assisted surgery involving the creation of a circular stapled anastomosis created within 10cm from the anal verge. 5. Procedure involving Total Mesorectal Excision by an abdominal or transanal approach. 6. 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
Exclusion criteria: Pre-operative exclusion criteria: 1. Female subject who is pregnant, breastfeeding, or if of child bearing potential is unwilling to practice birth control until 3 years following surgery. 2. 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. 3. Subject has a history of hypersensitivity to porcine derived gelatin or collagen. 4. Subject has a history of hypersensitivity to microbial Transglutaminase. 5. Subject has a known dysfibrinogenimeia, hypofibrinigenimia or a fibrinogenimia, without preoperative correction of fibrinogen levels. 6. Subject participating in any other study involving an investigational (unapproved) drug or device within the past 60 days. 7. Subject participating in studies involving approved drug or device will be enrolled only following a mutual consideration of the investigator together with the Sponsor. 8. Subject with a BMI *50, which may interfere with access to the surgical site and increase overall operative risk. 9. Subject with American Society of Anesthesiology (ASA) status higher than 3. 10. Avastin use within 30 days prior to surgery. 11. Subject who has undergone a prior pelvic anastomosis. 12. Subject is scheduled for another surgery during the first 6 months following surgery (not including stoma closure,placement of port for chemotherapy or ureter stent insertion). 13. Subject with an active abdominal or pelvic infection at the operation site. 14. Subject has been previously treated with LifeSeal* Surgical Sealant.;Intra-operative Exclusion Criteria 1. Anastomosis or procedure (TME) was performed differently from what was defined in the inclusion criteria. 2. Subject received intra-operative sealant, glue or any buttressing material other than the LifeSeal* Surgical Sealant. 3. Subject has peritoneal carcinomatosis. 4. Subject requires additional unrelated anastomosis during the surgery. 5. Subject is going through another surgical procedure (other than ileostomy or adhesiolysis) during the surgery. 6. Excessive bleeding (above 500cc) identified prior to anastomosis formation with the need for intra-operative blood transfusion.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary Efficacy Endpoint - The incidence of intra-operative and postoperative (clinical and radiologic) anastomotic leaks in high risk circular stapled colorectal and coloanal anastomoses up to 17 weeks after the initial surgery. | — |
Secondary
| Measure | Time frame |
|---|---|
| The secondary endpoints of this study are designed to focus on the incidence of postoperative leaks and to assess the impact of a leak once it occurs in high risk stapled colorectal or coloanal anastomoses. The order of the secondary endpoints will be tested in a pre-defined order that will be specified in the study Statistical Analysis Plan. See also paragraph 7.2 of the protocol. | — |
Countries
Belgium, Denmark, France, Israel, Italy, Netherlands, Sweden
Outcome results
None listed