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

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

Official Title
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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

Conditions
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Gastrointestinal Disease, Colorectal Disease

Intervention / Treatment
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* Procedure: Advant 55 Linear Cutter/Stapler
* Procedure: Suturing


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Stapling<br> | Procedure: Advant 55 Linear Cutter/Stapler<br>* Advant 55 Linear Cutter/Stapler<br>|
| Active Comparator: Suturing<br>4 layered hand-sutured anastomosis | Procedure: Suturing<br>* Suturing<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time of Surgery (Skin Open to Skin Close) |  | Day 1 | 
| Time of Anastomosis |  | Total time (minutes) from placement of stay suture to final anastomotic staple (Group II) or final anastomotic suture (Group I) | 
| Return to Bowel Activity |  | Number of days post-surgery to appearance of peristaltic movement | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Stapling, hand sutured anastamosis, colorectal disease