Clinical trial NCT02907385: Efficacy and Safety of LifeSeal™ Kit for Colorectal Staple Line Sealing
Official title: Efficacy and Safety of LifeSeal™ Kit for Staple Line Sealing in Colorectal and Coloanal Anastomoses: A Prospective Randomized Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Rectal Cancer
Anastomotic Leak
Keywords: Rectal Cancer
Low Anterior Resection
LifeSeal
Surgical Sealant
Lead sponsor: LifeBond Ltd.
Sponsor class: INDUSTRY
First posted: 2016-09-20
Enrollment: 736
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: LifeSeal™ Kit, surgical sealant designed for staple-line reinforcement that is applied over the anastomotic line to prevent bowel content leakage until full physiological function is restored.

RATIONALE : Postoperative anastomotic leakage is one of the most devastating and feared complications in colorectal surgery. The risk of postoperative anastomotic leakage varies widely depending on the level of anastomosis while the risk is higher in low anastomosis.

In order to best demonstrate the benefits of LifeSeal™ in providing staple line reinforcement and helping to reduce leaks, the study includes high risk anastomoses, defined as colorectal and coloanal anastomoses performed within 10 cm from the anal verge.

STUDY DESIGN: This study is designed as a prospective, multi-center, multinational randomized, single-blind, double armed study PRIMARY OBJECTIVE: 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.

SECONDARY OBJECTIVES: The secondary objective of this study is to assess the incidence of post-operative leaks and additional benefits that could be related to the use of LifeSeal™ Kit such as reducing the severity and improving the outcome of a leak once it has occurred. In addition, the study will allow for collection and analysis of additional safety data and usability assessment of the device, medical resource utilization, and health related quality of life measures.


Eligibility 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:

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 dysfibrinogenemia, hypofibrinogenemia or a fibrinogenemia, 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.

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Primary outcomes:
measure: Incidence of overall anastomotic leak
timeFrame: Up to 17 weeks post surgery
Secondary outcomes:
measure: Incidence of post operative anastomotic leaks
timeFrame: Up to 17 weeks post surgery
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: University of Southern CA
state: California
city: Stanford
country: United States
facility: Stanford University
state: California
city: Florida City
country: United States
facility: Florida Hospital
state: Florida
city: Tampa
country: United States
facility: Tampa General Hospital
state: Florida
city: Weston
country: United States
facility: Cleveland Clinic Florida
state: Florida
city: Chicago
country: United States
facility: University of Chicago
state: Illinois
city: Indianapolis
country: United States
facility: Franciscan
state: Indiana
city: Indianapolis
country: United States
facility: Indiana University
state: Indiana
city: Jefferson
country: United States
facility: Ochsner Clinic Foundation
state: Louisiana
city: Baltimore
country: United States
facility: Johns Hopkins Hospital
state: Maryland
city: Worcester
country: United States
facility: Medical University SC (MUSC)
state: Massachusetts
city: Worcester
country: United States
facility: University of Massachusetts
state: Massachusetts
city: Grand Rapids
country: United States
facility: Spectrum Health
state: Michigan
city: Saint Louis
country: United States
facility: Washington University
state: Missouri
city: Albany
country: United States
facility: Albany medical center
state: New York
city: New York
country: United States
facility: New York University
state: New York
city: Cleveland
country: United States
facility: Cleveland Clinic
state: Ohio
city: Cleveland
country: United States
facility: University Hospital Cleveland Medical Center
state: Ohio
city: State College
country: United States
facility: Penn state university
state: Pennsylvania
city: Durham
country: United States
facility: Duke University
state: South Carolina
city: Burlington
country: United States
facility: University of Vermont
state: Vermont
city: Charlottesville
country: United States
facility: University of Virginia
state: Virginia
city: Milwaukee
country: United States
facility: Medical College of Wisconsin
state: Wisconsin
city: Aalst
country: Belgium
facility: OLV Ziekenhuis Aalst
city: Genk
country: Belgium
facility: Ziekenhuis Oost-Limburg
city: Gent
country: Belgium
facility: Gent University Hospital
city: Leuven
country: Belgium
facility: University Hospital Leuven
city: Copenhagen
country: Denmark
facility: Bispebjerg Hospital
city: Roskilde
country: Denmark
facility: Zealand University Hospital
city: Petah Tikva
country: Israel
facility: Beilinson Rabin Medical Center
city: Tel Aviv
country: Israel
facility: Sourasky Medical Center
city: Tzrifin
country: Israel
facility: Assaf Harofeh Medical Center
city: Bologna
country: Italy
facility: Policlinico S.Orsola Malpighi
city: Milano
country: Italy
facility: Humanitas Research Hospital
city: Padova
country: Italy
facility: University of Padova
city: Eindhoven
country: Netherlands
facility: Catharina Hospital Eindhoven
city: Malmö
country: Sweden
facility: Lund University Hospital
city: Stockholm
country: Sweden
facility: Karolinska University Hospital
city: Uppsala
country: Sweden
facility: Uppsala University Hospital
Study officials:
References: