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

NCT ID: NCT00888849

Last Updated: 2011-12-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 280 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-04-30
• Study Completion Date: 2011-02-28

Brief Summary

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

Conditions

Gastrointestinal Disease; Colorectal Disease

Keywords

Stapling; hand sutured anastamosis; colorectal disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Stapling

Group Type: EXPERIMENTAL

Advant 55 Linear Cutter/Stapler

Intervention Type: PROCEDURE

Advant 55 Linear Cutter/Stapler

Suturing

4 layered hand-sutured anastomosis

Group Type: ACTIVE_COMPARATOR

Suturing

Intervention Type: PROCEDURE

Suturing

Interventions

Advant 55 Linear Cutter/Stapler

Advant 55 Linear Cutter/Stapler

Intervention Type: PROCEDURE

Suturing

Suturing

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ethicon Endo-Surgery

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Govt General Hospital and Madras Medical College

Chennai, , India

Indira Gandhi Government Medical College

Nagpur, , India

GB Pant Hospital

New Delhi, , India

Countries

India

References

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. doi: 10.1002/14651858.CD004320.pub2.

Reference Type: BACKGROUND

PMID: 17636751 (View on PubMed)

Other Identifiers

CI-07-0008

Identifier Type: -

Identifier Source: org_study_id