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)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Ethicon Endo-Surgery
ClinicalTrials.gov Identifier:
NCT00888849
First received: April 20, 2009
Last updated: November 30, 2011
Last verified: November 2011
  Purpose

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


Condition Intervention
Gastrointestinal Disease
Colorectal Disease
Procedure: Advant 55 Linear Cutter/Stapler
Procedure: Suturing

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Ethicon Endo-Surgery:

Primary Outcome Measures:
  • Time of Surgery (Skin Open to Skin Close) [ Time Frame: Day 1 ] [ Designated as safety issue: No ]
  • 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) ] [ Designated as safety issue: No ]
  • Return to Bowel Activity [ Time Frame: Number of days post-surgery to appearance of peristaltic movement ] [ Designated as safety issue: No ]

Enrollment: 280
Study Start Date: April 2009
Study Completion Date: February 2011
Primary Completion Date: October 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Stapling Procedure: Advant 55 Linear Cutter/Stapler
Advant 55 Linear Cutter/Stapler
Active Comparator: Suturing
4 layered hand-sutured anastomosis
Procedure: Suturing
Suturing

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00888849

Locations
India
Govt General Hospital and Madras Medical College
Chennai, India, 600003
Indira Gandhi Government Medical College
Nagpur, India, 440018
GB Pant Hospital
New Delhi, India, 110002
Sponsors and Collaborators
Ethicon Endo-Surgery
  More Information

Publications:
Responsible Party: Ethicon Endo-Surgery
ClinicalTrials.gov Identifier: NCT00888849     History of Changes
Other Study ID Numbers: CI-07-0008
Study First Received: April 20, 2009
Results First Received: October 18, 2011
Last Updated: November 30, 2011
Health Authority: India: Drugs Controller General of India

Keywords provided by Ethicon Endo-Surgery:
Stapling
hand sutured anastamosis
colorectal disease

Additional relevant MeSH terms:
Gastrointestinal Diseases
Digestive System Diseases

ClinicalTrials.gov processed this record on August 27, 2014