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

Gastrointestinal Disease Clinical Trial

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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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00888849
• Other study ID #: CI-07-0008
• Status: Completed
• Phase: N/A
• First received: April 20, 2009
• Last updated: November 30, 2011
• Start date: April 2009
• Est. completion date: February 2011

Study information

• Verified date: November 2011
• Source: Ethicon Endo-Surgery
• Contact: n/a
• Is FDA regulated: No
• Health authority: India: Drugs Controller General of India
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 280
• Est. completion date: February 2011
• Est. primary completion date: October 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Colorectal Disease
• Digestive System Diseases
• Gastrointestinal Disease
• Gastrointestinal Diseases

Intervention

Procedure:
• Advant 55 Linear Cutter/Stapler
Advant 55 Linear Cutter/Stapler
• Suturing
Suturing

Locations

Country	Name	City	State
India	Govt General Hospital and Madras Medical College	Chennai
India	Indira Gandhi Government Medical College	Nagpur
India	GB Pant Hospital	New Delhi

Sponsors (1)

Lead Sponsor	Collaborator
Ethicon Endo-Surgery

Country where clinical trial is conducted

India, 

References & Publications (1)

Choy PY, Bissett IP, Docherty JG, Parry BR, Merrie AE. Stapled versus handsewn methods for ileocolic anastomoses. Cochrane Database Syst Rev. 2007 Jul 18;(3):CD004320. Review. Update in: Cochrane Database Syst Rev. 2011;(9):CD004320. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time of Surgery (Skin Open to Skin Close)		Day 1	No
Primary	Time of Anastomosis		Total time (minutes) from placement of stay suture to final anastomotic staple (Group II) or final anastomotic suture (Group I)	No
Primary	Return to Bowel Activity		Number of days post-surgery to appearance of peristaltic movement	No