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

NCT00888849 | Completed Results

• 1 other identifier: CI-07-0008
• Study Type: interventional
• Target: 280
• Locations: 1 country
• Sites: 3

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

Outcome Measures

Primary Outcomes (3)

• Time of Surgery (Skin Open to Skin Close)

  Day 1

• Time of Anastomosis

  Total time (minutes) from placement of stay suture to final anastomotic staple (Group II) or final anastomotic suture (Group I)

• Return to Bowel Activity

  Number of days post-surgery to appearance of peristaltic movement

Study Arms (2)

Stapling

EXPERIMENTAL

Procedure: Advant 55 Linear Cutter/Stapler

Suturing

ACTIVE COMPARATOR

4 layered hand-sutured anastomosis

Procedure: Suturing

Interventions

Advant 55 Linear Cutter/Stapler PROCEDURE

Advant 55 Linear Cutter/Stapler

Stapling

Suturing PROCEDURE

Suturing

Suturing

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Able to comprehend and sign or, if illiterate, leave their thumb impression on the study informed consent document
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ethicon Endo-Surgery: lead

Study Sites (3)

Govt General Hospital and Madras Medical College

Chennai, 600003, India

Location

Indira Gandhi Government Medical College

Nagpur, 440018, India

Location

GB Pant Hospital

New Delhi, 110002, India

Location

Related 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. doi: 10.1002/14651858.CD004320.pub2.

  PMID: 17636751 BACKGROUND

MeSH Terms

Conditions

Gastrointestinal Diseases

Interventions

Sutures

Condition Hierarchy (Ancestors)

Digestive System Diseases

Intervention Hierarchy (Ancestors)

Surgical Fixation Devices; Surgical Equipment; Equipment and Supplies

Results Point of Contact

• Title: Sheryl Helsinger/Clinical Affairs Director
• Organization: Ethicon Endo Surgery, Inc

shelsing@its.jnj.com

513-337-3079

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 20, 2009
• First Posted: April 28, 2009
• Study Start: April 1, 2009
• Primary Completion: October 1, 2010
• Study Completion: February 1, 2011
• Last Updated: December 5, 2011
• Results First Posted: November 24, 2011

Record last verified: 2011-11

Locations

IN (3)