CTRI/2009/091/000311已完成4 期
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
Johnson and Johnson Ltd0 个研究点目标入组 300 人开始时间: 待定最近更新:
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 300
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Observational
入排标准
入选标准
- •a.Able to comprehend and sign or, if illiterate, leave their thumb impression on the study informed consent document;
- •b.18 years to 75 years (inclusive);
- •c.Admitted on an emergency or elective basis requiring a single gastrointestinal anastomosis;
- •d.Willing to adhere to standard postoperative care, including ventilator support if required;
- •e.Female subject is postmenopausal (for at least 2 years) or surgically incapable of child bearing (at least 3 months post-surgical sterilizilation, with appropriate documentation);
- •f.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; and
- •g.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.
排除标准
- •a.Women of childbearing potential who are pregnant at the time of screening or at the time of surgery;
- •b.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;
- •c.Subject has connective tissue disease, renal failure necessitating chronic hemodialysis or chronic ambulatory peritoneal dialysis as evidenced by serum creatinine of > 3mg/dL;
- •d.Subject has liver failure as evidenced by CP category C;
- •e.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;
- •f.Subject has extensive disseminated malignancy and unlikely to survive for more than 3 months based on investigator judgment;
- •g.Any subject that the investigator determines is not likely to be compliant during the study period;
- •h.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;
- •i.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; and
- •j.Participation in any other investigational device or drug study (non survey based trial) within 30 days of enrollment.
研究者
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