Status:
COMPLETED
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
Lead Sponsor:
Ethicon Endo-Surgery
Conditions:
Gastrointestinal Disease
Colorectal Disease
Eligibility:
All Genders
18-75 years
Phase:
NA
Brief Summary
This study is being conducted to compare surgical and patient outcomes across stapled (Group II) versus hand-sutured (Group I) groups.
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
April 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2011
Estimated Enrollment :
280 Patients enrolled
Trial Details
Trial ID
NCT00888849
Start Date
April 1 2009
End Date
February 1 2011
Last Update
December 5 2011
Active Locations (3)
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1
Govt General Hospital and Madras Medical College
Chennai, India, 600003
2
Indira Gandhi Government Medical College
Nagpur, India, 440018
3
GB Pant Hospital
New Delhi, India, 110002