An Open-label, Randomized, Prospective Study of the Effectiveness, Safety, and Clinical Outcomes of Stapled Anastomoses Versus Hand-Sutured Anastomoses in Patients Undergoing Gastrointestinal End to End or Side to Side Anastomoses (Tiger)

Ethicon

Status

Completed

Conditions

Colorectal Disease

Gastrointestinal Disease

Treatments

Procedure: Advant 55 Linear Cutter/Stapler

Procedure: Suturing

Study type

Interventional

Funder types

Industry

Identifiers

CI-07-0008

Details and patient eligibility

About

This study is being conducted to compare surgical and patient outcomes across stapled (Group II) versus hand-sutured (Group I) groups.

Enrollment

280 patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:a.

Able to comprehend and sign or, if illiterate, leave their thumb impression on the study informed consent document
18 years to 75 years (inclusive)
Admitted on an emergency or elective basis requiring a single gastrointestinal anastomosis
Willing to adhere to standard postoperative care, including ventilator support if required
Female subject is postmenopausal (for at least 2 years) or surgically incapable of child bearing (at least 3 months post-surgical sterilization, with appropriate documentation)
If female subject is capable of child bearing, must use an acceptable method of birth control (hormonal or IUD) for at least 3 months prior to surgery and continue use throughout the study; maintained normal menstrual pattern for the past three months and has a negative urine pregnancy test prior to day of surgical procedure
Absence of medical history of psychiatric disorders that could limit the subject's ability to understand the procedure, comply with medical, surgical, and/or behavioral recommendations.

Exclusion Criteria:

Women of childbearing potential who are pregnant at the time of screening or at the time of surgery
Subject is on treatment with Corticosteroid maintenance therapy (equivalent to > 10mg/day of Prednisone), immunosuppressive or chemotherapeutic agents within 14 days prior to enrollment; or likely to receive one of these drugs during study period
Subject has connective tissue disease, renal failure necessitating chronic hemodialysis or chronic ambulatory peritoneal dialysis as evidenced by serum creatinine of > 3mg/dL
Subject has liver failure as evidenced by CP category C
Immunocompromised subjects (hematological malignancies, history of bone marrow transplantation, splenectomized subjects, genetic disorders such as Lupus, severe combined immunodeficiency, etc.) or a positive HIV test result
Subject has extensive disseminated malignancy and unlikely to survive for more than 3 months based on investigator judgment
Any subject that the investigator determines is not likely to be compliant during the study period
Subjects determined or suspected to engage in substance abuse, or any subject who is currently, or has in the past 6 months, undergone substance abuse therapy
The investigator feels that the primary anastomosis is not feasible due to local conditions of the bowel or subject has unstable hemodynamic status requiring stoma
Participation in any other investigational device or drug study (non survey based trial) within 30 days of enrollment.