- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00888849
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)
November 30, 2011 updated by: Ethicon Endo-Surgery
This study is being conducted to compare surgical and patient outcomes across stapled (Group II) versus hand-sutured (Group I) groups.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
280
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Chennai, India, 600003
- Govt General Hospital and Madras Medical College
-
Nagpur, India, 440018
- Indira Gandhi Government Medical College
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New Delhi, India, 110002
- GB Pant Hospital
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 75 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Stapling
|
Advant 55 Linear Cutter/Stapler
|
Active Comparator: Suturing
4 layered hand-sutured anastomosis
|
Suturing
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Time of Surgery (Skin Open to Skin Close)
Time Frame: Day 1
|
Day 1
|
Time of Anastomosis
Time Frame: Total time (minutes) from placement of stay suture to final anastomotic staple (Group II) or final anastomotic suture (Group I)
|
Total time (minutes) from placement of stay suture to final anastomotic staple (Group II) or final anastomotic suture (Group I)
|
Return to Bowel Activity
Time Frame: Number of days post-surgery to appearance of peristaltic movement
|
Number of days post-surgery to appearance of peristaltic movement
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
April 1, 2009
Primary Completion (Actual)
October 1, 2010
Study Completion (Actual)
February 1, 2011
Study Registration Dates
First Submitted
April 20, 2009
First Submitted That Met QC Criteria
April 27, 2009
First Posted (Estimate)
April 28, 2009
Study Record Updates
Last Update Posted (Estimate)
December 5, 2011
Last Update Submitted That Met QC Criteria
November 30, 2011
Last Verified
November 1, 2011
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CI-07-0008
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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