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
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Gastrointestinal Disease
Colorectal Disease
Keywords: Stapling
hand sutured anastamosis
colorectal disease
Lead sponsor: Ethicon Endo-Surgery
Sponsor class: INDUSTRY
First posted: 2009-04-28
Enrollment: 280
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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


Eligibility 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.

Primary outcomes:
measure: Time of Surgery (Skin Open to Skin Close)
timeFrame: Day 1
measure: Time of Anastomosis
timeFrame: Total time (minutes) from placement of stay suture to final anastomotic staple (Group II) or final anastomotic suture (Group I)
measure: Return to Bowel Activity
timeFrame: Number of days post-surgery to appearance of peristaltic movement
Secondary outcomes:
Other outcomes:
Locations:
city: Chennai
country: India
facility: Govt General Hospital and Madras Medical College
city: Nagpur
country: India
facility: Indira Gandhi Government Medical College
city: New Delhi
country: India
facility: GB Pant Hospital
Study officials:
References:
citation: 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.